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1. Modes of death and prognostic outliers in chronic heart failure.

Author

Canepa M, Ameri P, Lucci D, Nicolosi GL, Marchioli R, Porcu M, Tognoni G, Franzosi MG, Latini R, Maseri A, Tavazzi L, and Maggioni AP

Subjects
Aged, Area Under Curve, Cause of Death, Female, Heart Failure physiopathology, Humans, Incidence, Male, Probability, Prognosis, Risk Assessment, Stroke Volume, Death, Sudden, Cardiac epidemiology, Heart Failure mortality
Abstract

Background: The impact of incident sudden cardiac death (SCD) on the predictive accuracy of prognostic risk scores for patients with chronic heart failure (HF) has rarely been examined. We assessed the relationship between estimated probability of death and modes of death in this population, as well as the predictors of death and survival in prognostic outliers., Methods and Results: The MAGGIC 3-year probability of death was estimated in 6,859 participants of the GISSI-HF trial (mean age 67±11 years, 78% men, 91% with ejection fraction <40%, mean follow-up 3.5±1.3 years, observed mortality 28.4%). The incidence of SCD progressively decreased with increased probability of death, and occurred in 52.5% of patients estimated at low-risk (N = 61 with probability <14%) vs. in 23.5% of the high-risk ones (N = 375 with probability >56%, P < .0001). On the contrary, death from worsening HF was significantly more frequent in the latter group (19.7% vs. 46.1%, P < .0001). The overall predictive accuracy of the MAGGIC model improved after excluding deaths from SCD (AUC from 0.731 to 0.760, P = .0034). Among patients estimated at low-risk (N = 61 dead, 743 alive), independent predictors of death were older age, longer history of HF, higher serum uric acid and chronic obstructive pulmonary disease. The only predictor of survival in patients estimated at high-risk (N = 210 alive, 375 dead) was higher systolic blood pressure., Conclusions: The MAGGIC risk score demonstrated its scarce ability to capture SCD, particularly in chronic HF patients estimated at low risk of death. Newer and better prognostic tools in the evolving horizon of HF are needed., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Published
2019
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2. Treatment with insulin is associated with worse outcome in patients with chronic heart failure and diabetes.

Author

Cosmi F, Shen L, Magnoli M, Abraham WT, Anand IS, Cleland JG, Cohn JN, Cosmi D, De Berardis G, Dickstein K, Franzosi MG, Gullestad L, Jhund PS, Kjekshus J, Køber L, Lepore V, Lucisano G, Maggioni AP, Masson S, McMurray JJV, Nicolucci A, Petrarolo V, Robusto F, Staszewsky L, Tavazzi L, Teli R, Tognoni G, Wikstrand J, and Latini R

Subjects
Aged, Cause of Death trends, Comorbidity, Diabetes Mellitus, Type 2 epidemiology, Double-Blind Method, Female, Heart Failure diagnosis, Heart Failure physiopathology, Humans, Hypoglycemic Agents therapeutic use, Italy epidemiology, Male, Prognosis, Propensity Score, Risk Factors, Survival Rate trends, Diabetes Mellitus, Type 2 drug therapy, Heart Failure epidemiology, Insulin therapeutic use, Registries
Abstract

Aims: Up to one-third of patients with diabetes mellitus and heart failure (HF) are treated with insulin. As insulin causes sodium retention and hypoglycaemia, its use might be associated with worse outcomes., Methods and Results: We examined two datasets: 24 012 patients with HF from four large randomized trials and an administrative database of 4 million individuals, 103 857 of whom with HF. In the former, survival was examined using Cox proportional hazards models adjusted for baseline variables and separately for propensity scores. Fine-Gray competing risk regression models were used to assess the risk of hospitalization for HF. For the latter, a case-control nested within a population-based cohort study was conducted with propensity score. Prevalence of diabetes mellitus at study entry ranged from 25.5% to 29.5% across trials. Insulin alone or in combination with oral hypoglycaemic drugs was prescribed at randomization to 24.4% to 34.5% of the patients with diabetes. The rates of death from any cause and hospitalization for HF were higher in patients with vs. without diabetes, and highest of all in patients prescribed insulin [propensity score pooled hazard ratio for all-cause mortality 1.27 (1.16-1.38), for HF hospitalization 1.23 (1.13-1.33)]. In the administrative registry, insulin prescription was associated with a higher risk of all-cause death [odds ratio (OR) 2.02, 95% confidence interval (CI) 1.87-2.19] and rehospitalization for HF (OR 1.42, 95% CI 1.32-1.53)., Conclusions: Whether insulin use is associated with poor outcomes in HF should be investigated further with controlled trials, as should the possibility that there may be safer alternative glucose-lowering treatments for patients with HF and type 2 diabetes mellitus., (© 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.)

Published
2018
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3. Red blood cell oleic acid levels reflect olive oil intake while omega-3 levels reflect fish intake and the use of omega-3 acid ethyl esters: The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Heart Failure trial.

Author

Harris WS, Masson S, Barlera S, Milani V, Pileggi S, Franzosi MG, Marchioli R, Tognoni G, Tavazzi L, and Latini R

Subjects
Aged, Animals, Diet, Erythrocytes metabolism, Esters therapeutic use, Fatty Acids, Omega-3 blood, Fatty Acids, Omega-3 therapeutic use, Female, Heart Failure drug therapy, Heart Failure metabolism, Humans, Hypolipidemic Agents administration & dosage, Hypolipidemic Agents pharmacology, Male, Middle Aged, Olea, Oleic Acid blood, Oleic Acid therapeutic use, Olive Oil administration & dosage, Risk Factors, Seafood, Esters pharmacology, Fatty Acids, Omega-3 pharmacology, Feeding Behavior, Fishes, Heart Failure blood, Oleic Acid pharmacology, Olive Oil pharmacology
Abstract

The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico-Heart Failure (GISSI-HF) study reported benefits of n-3 fatty acid (FA) treatment on cardiovascular (CV) events, but the effects of treatment on a putative CV disease risk factor, the red blood cell (RBC) n-3 FA level (the omega-3 index), have not been examined in this context. We hypothesized that treatment with prescription omega-3 acid ethyl esters (O3AEE) would increase the omega-3 index to the proposed cardioprotective value of 8%. RBCs were collected from a subset of patients participating in the GISSI-HF study (n=461 out of 6975 randomized), at baseline and after 3 months of treatment with either an olive oil placebo or O3AEE (1 g/d). RBC FA levels were expressed as a percentage of total FA. Patients also reported their typical olive oil and fish intakes. RBC oleic acid levels were directly correlated with reported frequency of olive oil consumption, and the omega-3 index was correlated with reported fish intake (P for trends <0.001 for both). After treatment, the omega-3 index increased from 4.8±1.7% to 6.7±1.9% but was unchanged in the placebo group (4.7±1.7 to 4.8±1.5%) (P<.0001 for changes between groups). At 3 months, more patients reached the proposed target omega-3 index level of 8%-12% in the treated vs placebo group (22.6% vs. 1.3%, P<.0001), however, what omega-3 index levels were ultimately achieved after four years in this trial are unknown., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Published
2016
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4. The Anp genetic variant Rs5068 and circulating levels of natriuretic peptides in patients with chronic heart failure.

Author

Cannone V, Barlera S, Pileggi S, Masson S, Franzosi MG, Latini R, Scardulla C, Clemenza F, Maggioni AP, Nicolosi GL, Tavazzi L, and Burnett JC Jr

Subjects
Aged, Atrial Natriuretic Factor blood, Female, Genetic Variation, Genotype, Heart Failure blood, Humans, Male, Natriuretic Peptides blood, Atrial Natriuretic Factor genetics, DNA genetics, Heart Failure genetics
Published
2014
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5. Predictors of mortality in 6975 patients with chronic heart failure in the Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico-Heart Failure trial: proposal for a nomogram.

Author

Barlera S, Tavazzi L, Franzosi MG, Marchioli R, Raimondi E, Masson S, Urso R, Lucci D, Nicolosi GL, Maggioni AP, and Tognoni G

Subjects
Aged, Cause of Death trends, Female, Fibrinolytic Agents therapeutic use, Follow-Up Studies, Heart Failure drug therapy, Heart Failure physiopathology, Humans, Italy epidemiology, Male, Prognosis, Proportional Hazards Models, Retrospective Studies, Risk Factors, Survival Rate trends, Treatment Outcome, Troponin T blood, Heart Failure mortality, Nomograms, Streptokinase therapeutic use, Ventricular Function, Left physiology
Abstract

Background: We developed a prognostic model to assess the risk of all-cause mortality in patients with chronic heart failure., Methods and Results: We examined 6975 patients with chronic heart failure enrolled in the Gruppo Italiano per lo Studio della Streptochinasi nell'Infarto Miocardico-Heart Failure (GISSI-HF) trial (3.9 years follow-up). Multivariable Cox regression models were developed to predict mortality (1969 deaths). By stepwise selection, the full final model included 25 predictors. A reduced model, considering the most significant variables ranked according to the Wald χ(2) (P<0.0001) accounted for most of the prognostic information. Internal validation of the model was performed with bootstrap techniques. The discrimination ability of the reduced model constituted by 12 factors (concordance probability estimate, 0.693) was as good as the full final model (concordance probability estimate, 0.70). Among the first 12 independent risk factors emerging in the reduced model, the 3 most powerful predictors were older age, higher New York Heart Association class, and lower estimated glomerular filtration rate. Other independent predictors that increased risk included lower left ventricular ejection fraction, chronic obstructive pulmonary disease, lower systolic blood pressure, diabetes mellitus, male sex, higher uricemia, lower body mass index, lower hemoglobin, and aortic stenosis. The reduced model was used to build a nomogram to estimate the risk of death in individual patients. In a subgroup of patients, the 2 well-known biomarkers (high-sensitivity cardiac troponin T and N-terminal pro-brain natriuretic peptide) emerged as the most powerful predictors of outcome., Conclusions: In a large contemporary population with chronic heart failure, this model offers good ability to assess the risk of death, confirming most of the risk factors that have emerged in recent trials., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00336336.

Published
2013
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6. Adiponectin in chronic heart failure: influence of diabetes and genetic variants.

Author

Masson S, Gori F, Latini R, Milani V, Flyvbjerg A, Frystyk J, Crociati L, Pietri S, Vago T, Barlera S, Maggioni AP, Tognoni G, Tavazzi L, Omland T, and Franzosi MG

Subjects
Adiponectin metabolism, Age Factors, Aged, Aged, 80 and over, Body Mass Index, Diabetes Mellitus, Type 2 complications, Female, Genetic Predisposition to Disease genetics, Heart Failure blood, Heart Failure complications, Humans, Male, Middle Aged, Polymorphism, Single Nucleotide, Risk Factors, Sex Factors, Survival Analysis, Adiponectin genetics, Diabetes Mellitus, Type 2 genetics, Heart Failure genetics
Abstract

Background: We hypothesized that, besides type 2 diabetes (T2D) and body mass index (BMI), circulating adiponectin concentration would be associated with variants of the ADIPOQ gene in patients with chronic heart failure (CHF). We also assessed the influence of these confounders on the prognostic value of adiponectin., Methods: Plasma adiponectin was measured at entry and after 3 months in approximately 1200 patients with CHF enrolled in the GISSI-HF trial. Four common single-nucleotide polymorphisms (SNPs) spanning the ADIPOQ gene were studied: rs17300539 (-11391G→A), rs266729 (-11377C→G), rs2241766 (+45T→G) and rs1501299 (+276G→T). Associations with clinical characteristics and mortality were evaluated in patients with or without T2D., Results: Adiponectin concentrations were negatively related to BMI, higher in women and older persons, but lower in patients with diabetes. T-allele carriers for rs1501299 and A-allele carriers for rs17300539 had significantly elevated adiponectin concentrations. Irrespective of diabetes, baseline plasma adiponectin was independently associated with mortality (adjusted HR [95%CI] per 1 SD increase in adiponectin concentration = 1·24[1·12-1·37], P < 0·0001) and improved prognostic discrimination beyond clinical risk factors (integrated discrimination improvement, P = 0·005). Patients with increasing adiponectin concentration over 3 months had worse outcome than those with stable levels (unadjusted HR = 1·46[1·09-1·96], P = 0·01); this relation was attenuated by the genetic variants examined and by robust confounders like age, diabetes, BMI or NT-proBNP (adjusted HR = 1·37[0·97-1·94], P = 0·075)., Conclusions: Although diabetes and genetic variants at the ADIPOQ gene influence the circulating levels of adiponectin in CHF, higher plasma adipokine levels, but not genetic variants, are consistently associated with a poor prognosis., (© 2011 The Authors. European Journal of Clinical Investigation © 2011 Stichting European Society for Clinical Investigation Journal Foundation.)

Published
2011
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7. Effects of rosuvastatin on atrial fibrillation occurrence: ancillary results of the GISSI-HF trial.

Author

Maggioni AP, Fabbri G, Lucci D, Marchioli R, Franzosi MG, Latini R, Nicolosi GL, Porcu M, Cosmi F, Stefanelli S, Tognoni G, and Tavazzi L

Subjects
Aged, Chronic Disease, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Risk Factors, Rosuvastatin Calcium, Treatment Outcome, Anti-Arrhythmia Agents therapeutic use, Atrial Fibrillation drug therapy, Fatty Acids, Omega-3 therapeutic use, Fluorobenzenes therapeutic use, Heart Failure drug therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Pyrimidines therapeutic use, Sulfonamides therapeutic use
Abstract

Aims: This ancillary analysis of the GISSI-HF database aims at assessing the effect of rosuvastatin on the occurrence of atrial fibrillation (AF) in patients with chronic heart failure (HF) who were not in AF at study entry., Methods and Results: GISSI-HF was a double-blind, placebo-controlled trial testing n-3 PUFA and rosuvastatin vs. corresponding placebos in patients with chronic HF. Atrial fibrillation occurrence was defined as the presence of AF in the electrocardiogram (ECG) performed at each visit during the trial or AF as a cause of worsening HF or hospital admission or as an event during hospitalization. Among the 3690 patients (80.7%) without AF on their baseline ECG, 15.0% developed AF during a median follow-up period of 3.7 years, 258 randomized to rosuvastatin (13.9%) vs. 294 allocated to placebo (16.0%). Although the difference was not significant at unadjusted analysis (P = 0.097) and multivariable analysis adjusting for clinical variables (P = 0.067), it became significant after adjustment for clinical variables and laboratory examinations (P = 0.039), and for clinical variables, laboratory examinations, and background therapies (P = 0.038)., Conclusion: This study shows that there is some evidence of a beneficial effect of rosuvastatin in terms of reduction of AF occurrence in patients with HF. Larger populations are needed to provide a definite answer to the question. ClinicalTrials.gov Identifier: NCT00336336.

Published
2009
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8. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.

Author

Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, and Tognoni G

Subjects
Aged, Chronic Disease, Double-Blind Method, Female, Fluorobenzenes adverse effects, Heart Failure classification, Heart Failure mortality, Hospitalization statistics & numerical data, Humans, Hydroxymethylglutaryl-CoA Reductase Inhibitors adverse effects, Italy, Male, Proportional Hazards Models, Pyrimidines adverse effects, Rosuvastatin Calcium, Sulfonamides adverse effects, Fluorobenzenes therapeutic use, Heart Failure drug therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Pyrimidines therapeutic use, Sulfonamides therapeutic use
Abstract

Background: Large observational studies, small prospective studies and post-hoc analyses of randomised clinical trials have suggested that statins could be beneficial in patients with chronic heart failure. However, previous studies have been methodologically weak. We investigated the efficacy and safety of the statin rosuvastatin in patients with heart failure., Methods: We undertook a randomised, double-blind, placebo-controlled trial in 326 cardiology and 31 internal medicine centres in Italy. We enrolled patients aged 18 years or older with chronic heart failure of New York Heart Association class II-IV, irrespective of cause and left ventricular ejection fraction, and randomly assigned them to rosuvastatin 10 mg daily (n=2285) or placebo (n=2289) by a concealed, computerised telephone randomisation system. Patients were followed up for a median of 3.9 years (IQR 3.0-4.4). Primary endpoints were time to death, and time to death or admission to hospital for cardiovascular reasons. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00336336., Findings: We analysed all randomised patients. 657 (29%) patients died from any cause in the rosuvastatin group and 644 (28%) in the placebo group (adjusted hazard ratio [HR] 1.00 [95.5% CI 0.898-1.122], p=0.943). 1305 (57%) patients in the rosuvastatin group and 1283 (56%) in the placebo group died or were admitted to hospital for cardiovascular reasons (adjusted HR 1.01 [99% CI 0.908-1.112], p=0.903). In both groups, gastrointestinal disorders were the most frequent adverse reaction (34 [1%] rosuvastatin group vs 44 [2%] placebo group)., Interpretation: Rosuvastatin 10 mg daily did not affect clinical outcomes in patients with chronic heart failure of any cause, in whom the drug was safe.

Published
2008
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9. Effect of n-3 polyunsaturated fatty acids in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.

Author

Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, and Tognoni G

Subjects
Aged, Chronic Disease, Double-Blind Method, Endpoint Determination, Fatty Acids, Omega-3 adverse effects, Fatty Acids, Omega-3 pharmacology, Female, Follow-Up Studies, Heart Failure classification, Heart Failure mortality, Hospitalization statistics & numerical data, Humans, Italy, Male, Ventricular Function, Left drug effects, Fatty Acids, Omega-3 therapeutic use, Heart Failure drug therapy
Abstract

Background: Several epidemiological and experimental studies suggest that n-3 polyunsaturated fatty acids (PUFA) can exert favourable effects on atherothrombotic cardiovascular disease, including arrhythmias. We investigated whether n-3 PUFA could improve morbidity and mortality in a large population of patients with symptomatic heart failure of any cause., Methods: We undertook a randomised, double-blind, placebo-controlled trial in 326 cardiology and 31 internal medicine centres in Italy. We enrolled patients with chronic heart failure of New York Heart Association class II-IV, irrespective of cause and left ventricular ejection fraction, and randomly assigned them to n-3 PUFA 1 g daily (n=3494) or placebo (n=3481) by a concealed, computerised telephone randomisation system. Patients were followed up for a median of 3.9 years (IQR 3.0-4.5). Primary endpoints were time to death, and time to death or admission to hospital for cardiovascular reasons. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00336336., Findings: We analysed all randomised patients. 955 (27%) patients died from any cause in the n-3 PUFA group and 1014 (29%) in the placebo group (adjusted hazard ratio [HR] 0.91 [95.5% CI 0.833-0.998], p=0.041). 1981 (57%) patients in the n-3 PUFA group and 2053 (59%) in the placebo group died or were admitted to hospital for cardiovascular reasons (adjusted HR 0.92 [99% CI 0.849-0.999], p=0.009). In absolute terms, 56 patients needed to be treated for a median duration of 3.9 years to avoid one death or 44 to avoid one event like death or admission to hospital for cardiovascular reasons. In both groups, gastrointestinal disorders were the most frequent adverse reaction (96 [3%] n-3 PUFA group vs 92 [3%] placebo group)., Interpretation: A simple and safe treatment with n-3 PUFA can provide a small beneficial advantage in terms of mortality and admission to hospital for cardiovascular reasons in patients with heart failure in a context of usual care.

Published
2008
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10. Rationale and design of the GISSI heart failure trial: a large trial to assess the effects of n-3 polyunsaturated fatty acids and rosuvastatin in symptomatic congestive heart failure.

Author

Tavazzi L, Tognoni G, Franzosi MG, Latini R, Maggioni AP, Marchioli R, Nicolosi GL, and Porcu M

Subjects
Fatty Acids, Omega-3, Humans, Randomized Controlled Trials as Topic, Research Design, Rosuvastatin Calcium, Fatty Acids, Unsaturated therapeutic use, Fluorobenzenes therapeutic use, Heart Failure drug therapy, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Hypolipidemic Agents therapeutic use, Pyrimidines therapeutic use, Sulfonamides therapeutic use, Triglycerides therapeutic use
Abstract

Background: The GISSI Heart Failure project is a large-scale, randomized, double-blind study designed to investigate the effects of n-3 polyunsaturated fatty acids and rosuvastatin on mortality and morbidity in patients with symptomatic heart failure., Methods and Results: Patients with New York Heart Association classes II to IV heart failure, already receiving optimized recommended therapy, will be recruited in a nation-wide network of more than 300 cardiology and internal medicine services to be randomly allocated to treatment with n-3 polyunsaturated fatty acids (1 g daily) or the corresponding placebo. Patients with no clear indication or contraindication to cholesterol-lowering therapy will be further randomized to receive low-dose rosuvastatin (10 mg daily) or placebo. According to data available in heart failure registries, it is expected that 70% of the patients will be suitable to enter both components of the trial, which assume the same co-primary endpoints: (a) 15% reduction of all-cause mortality and (b) 20% reduction of all-cause mortality or cardiovascular hospitalizations. The trial is event-driven and will continue either until at least 1252 deaths have been recorded or a reduction of all-cause mortality will satisfy the significance boundaries, which have been established to stop the study. The recruitment of the planned sample size of approximately 7000 patients randomized in the n-3 PUFA trial is expected to be completed within 18 months from the trial start. As of February 29, 2004, 4624 heart failure patients have been included in the trial., Conclusion: The GISSI-HF project, with its protocol articulated into two independent randomization schemes, has the aim and the power to verify the hypothesis that n-3 polyunsaturated fatty acids and rosuvastatin can favorably modify the prognosis of patients with symptomatic heart failure.

Published
2004
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11. Treatment with insulin is associated with worse outcome in patients with chronic heart failure and diabetes

Author

Cosmi, Franco, Shen, Li, Magnoli, Michela, Abraham, William T., Anand, Inder S., Cleland, John G., Cohn, Jay N., Cosmi, Deborah, De Berardis, Giorgia, Dickstein, Kenneth, Franzosi, Maria Grazia, Gullestad, Lars, Jhund, Pardeep S., Kjekshus, John, Køber, Lars, Lepore, Vito, Lucisano, Giuseppe, Maggioni, Aldo P., Masson, Serge, McMurray, John J.V., Nicolucci, Antonio, Petrarolo, Vito, Robusto, Fabio, Staszewsky, Lidia, Tavazzi, Luigi, Teli, Roberto, Tognoni, Gianni, Wikstrand, John, and Latini, Roberto

Subjects
Diabetes mellitus, Cardiovascular System & Hematology, Insulin, Heart failure, R1, 1102 Cardiovascular Medicine And Haematology
Abstract

Aims: \ud Up to one-third of patients with diabetes mellitus and heart failure (HF) are treated with insulin. As insulin causes sodium retention and hypoglycaemia, its use might be associated with worse outcomes.\ud \ud Methods and results: \ud We examined two datasets: 24 012 patients with HF from four large randomized trials and an administrative database of 4 million individuals, 103 857 of whom with HF. In the former, survival was examined using Cox proportional hazards models adjusted for baseline variables and separately for propensity scores. Fine–Gray competing risk regression models were used to assess the risk of hospitalization for HF. For the latter, a case–control nested within a population-based cohort study was conducted with propensity score. Prevalence of diabetes mellitus at study entry ranged from 25.5% to 29.5% across trials. Insulin alone or in combination with oral hypoglycaemic drugs was prescribed at randomization to 24.4% to 34.5% of the patients with diabetes. The rates of death from any cause and hospitalization for HF were higher in patients with vs. without diabetes, and highest of all in patients prescribed insulin [propensity score pooled hazard ratio for all-cause mortality 1.27 (1.16–1.38), for HF hospitalization 1.23 (1.13–1.33)]. In the administrative registry, insulin prescription was associated with a higher risk of all-cause death [odds ratio (OR) 2.02, 95% confidence interval (CI) 1.87–2.19] and rehospitalization for HF (OR 1.42, 95% CI 1.32–1.53).\ud \ud Conclusions: \ud Whether insulin use is associated with poor outcomes in HF should be investigated further with controlled trials, as should the possibility that there may be safer alternative glucose-lowering treatments for patients with HF and type 2 diabetes mellitus.

Published
2018

12. Effects of rosuvastatin on atrial fibrillation occurrence: Ancillary results of the GISSI-HF trial

Author

Maggioni, Aldo P., Fabbri, Gianna, Lucci, Donata, Marchioli, Roberto, Franzosi, Maria Grazia, Latini, Roberto, Nicolosi, Gian Luigi, Porcu, Maurizio, Cosmi, Franco, Stefanelli, Severo, Tognoni, Gianni, Tavazzi, Luigi, and Pende, Aldo

Subjects
Male, medicine.medical_specialty, Heart disease, Heart failure, Kaplan-Meier Estimate, Placebo, law.invention, Rosuvastatin, Pharmacotherapy, Randomized controlled trial, Double-Blind Method, Drug Therapy, law, Risk Factors, Internal medicine, Fatty Acids, Omega-3, Atrial Fibrillation, medicine, Humans, Rosuvastatin Calcium, Aged, Omega-3, Sulfonamides, business.industry, Atrial fibrillation, Anti-Arrhythmia Agents, Chronic Disease, Drug Therapy, Combination, Female, Fluorobenzenes, Heart Failure, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Middle Aged, Pyrimidines, Treatment Outcome, Cardiology and Cardiovascular Medicine, Fatty Acids, medicine.disease, Combination, Cardiology, business, medicine.drug
Abstract

Aims This ancillary analysis of the GISSI-HF database aims at assessing the effect of rosuvastatin on the occurrence of atrial fibrillation (AF) in patients with chronic heart failure (HF) who were not in AF at study entry. Methods and results GISSI-HF was a double-blind, placebo-controlled trial testing n-3 PUFA and rosuvastatin vs. corresponding placebos in patients with chronic HF. Atrial fibrillation occurrence was defined as the presence of AF in the electrocardiogram (ECG) performed at each visit during the trial or AF as a cause of worsening HF or hospital admission or as an event during hospitalization. Among the 3690 patients (80.7%) without AF on their baseline ECG, 15.0% developed AF during a median follow-up period of 3.7 years, 258 randomized to rosuvastatin (13.9%) vs. 294 allocated to placebo (16.0%). Although the difference was not significant at unadjusted analysis ( P = 0.097) and multivariable analysis adjusting for clinical variables ( P = 0.067), it became significant after adjustment for clinical variables and laboratory examinations ( P = 0.039), and for clinical variables, laboratory examinations, and background therapies ( P = 0.038). Conclusion This study shows that there is some evidence of a beneficial effect of rosuvastatin in terms of reduction of AF occurrence in patients with HF. Larger populations are needed to provide a definite answer to the question. ClinicalTrials.gov Identifier: NCT00336336

Published
2009

13. Predicting atrial fibrillation recurrence with circulating inflammatory markers in patients in sinus rhythm at high risk for atrial fibrillation: data from the GISSI atrial fibrillation trial.

Author

Masson, Serge, Aleksova, Aneta, Favero, Chiara, Staszewsky, Lidia, Bernardinangeli, Marino, Belvito, Chiara, Cioffi, Giovanni, Sinagra, Gianfranco, Mazzone, Carmine, Bertocchi, Federico, Vago, Tarcisio, Peri, Giuseppe, Cuccovillo, Ivan, Masuda, Nobuhito, Barlera, Simona, Mantovani, Alberto, Maggioni, Aldo P., Franzosi, Maria Grazia, Disertori, Marcello, and Latini, Roberto

Subjects
INFLAMMATION, ATRIAL fibrillation, INTERLEUKIN-6, ECHOCARDIOGRAPHY, HEART diseases, HEART failure
Abstract

Background Inflammation may play a significant role in the pathogenesis of atrial fibrillation (AF). Objectives To examine the roles of three systemic inflammatory markers in predicting recurrent AF. Methods The association between the plasma concentrations of high-sensitivity C reactive protein (hsCRP), interleukin-6 (IL-6) and pentraxin-3 (PTX3) with echocardiographic parameters and with the time to first recurrence of AF was tested in 382 patients with a history of AF but in sinus rhythm at randomisation, enrolled in the GISSI-AF biohumoral study. Results Baseline PTX3 was related to left atrial, but not to left ventricular chamber volume. During one year of follow-up, 204 patients (53.1%) had a recurrent AF. There were no significant differences in baseline median [Q1-Q3] plasma concentrations of IL-6, hsCRP and PTX3 among patients with (2.11 [1.47-3.74] pg/ml, 3.30 [1.40-6.80] mg/l and 4.66 [3.27-6.97] ng/ml, respectively) or without recurrent AF (2.09 [1.37-2.90] pg/ml, p=0.182; 3.00 [1.10-6.20] mg/l, p=0.333; 5.09 [3.22-7.98] ng/ml, p=0.637). At 6 and 12⇔…months follow-up, AF patients had significantly higher concentrations of IL-6 and PTX3 than those in sinus rhythm, and those with most recent episodes of AF had higher hsCRP. Baseline levels of IL-6, hsCRP or PTX3 were not significantly associated with a higher risk of recurrence of AF. Conclusion In patients with a history of AF, but without significant left ventricular dysfunction or heart failure, inflammatory biomarkers may be raised but are, at best, weak predictors of the risk for first recurrence of AF. [ABSTRACT FROM AUTHOR]

Published
2010
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14. Prognostic Impact of Diabetes and Prediabetes on Survival Outcomes in Patients With Chronic Heart Failure: A Post-Hoc Analysis of the GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca-Heart Failure) Trial

Author

Marco Dauriz, Giovanni Targher, Pier Luigi Temporelli, Donata Lucci, Lucio Gonzini, Gian Luigi Nicolosi, Roberto Marchioli, Gianni Tognoni, Roberto Latini, Franco Cosmi, Luigi Tavazzi, Aldo Pietro Maggioni, Simona Barlera, Maria Grazia Franzosi, Aldo P. Maggioni, Maurizio Porcu, Salim Yusuf, Fulvio Camerini, Jay N. Cohn, Adriano Decarli, Bertram Pitt, Peter Sleight, Philip A. Poole‐Wilson, Enrico Geraci, Marino Scherillo, Gianna Fabbri, Barbara Bartolomei, Daniele Bertoli, Franco Cobelli, Claudio Fresco, Antonietta Ledda, Giacomo Levantesi, Cristina Opasich, Franco Rusconi, Gianfranco Sinagra, Fabio Turazza, Alberto Volpi, Martina Ceseri, Gianluca Alongi, Antonio Atzori, Filippo Bambi, Desiree Bastarolo, Francesca Bianchini, Iacopo Cangioli, Vittoriana Canu, Concetta Caporusso, Gabriele Cenni, Laura Cintelli, Michele Cocchio, Alessia Confente, Eva Fenicia, Giorgio Friso, Marco Gianfriddo, Gianluca Grilli, Beatrice Lazzaro, Giuseppe Lonardo, Alessia Luise, Rachele Nota, Mariaelena Orlando, Rosaria Petrolo, Chiara Pierattini, Valeria Pierota, Alessandro Provenzani, Velia Quartuccio, Anna Ragno, Chiara Serio, Alvise Spolaor, Arianna Tafi, Elisa Tellaroli, Stefano Ghio, Elisa Ghizzardi, Serge Masson, Lella Crociati, Maria Teresa La Rovere, Ugo Corrà, Andrea Finzi, Marco Gorini, Valentina Milani, Giampietro Orsini, Elisa Bianchini, Silvia Cabiddu, Ilaria Cangioli, Laura Cipressa, Maria Lucia Cipressa, Giuseppina Di Bitetto, Barbara Ferri, Luisa Galbiati, Andrea Lorimer, Carla Pera, Paola Priami, Antonella Vasamì, T. Moccetti, M.G. Rossi, E. Pasotti, F. Vaghi, P. Roncarolo, M.T. Zunino, F. Matta, E. Actis Perinetto, F. Gaita, G. Azzaro, M. Zanetta, A.M. Paino, U. Parravicini, D. Vegis, R. Conte, P. Ferraro, A. De Bernardi, S. Morelloni, M. Fagnani, P. Greco Lucchina, L. Montagna, E. Bellone, D. Sappè, F. Ferraro, M. Delucchi, S.G. Reynaud, M. Dore, A. La Brocca, N. Massobrio, L. Bo, R. Trinchero, M. Imazio, G. Brocchi, A. Nejrotti, L. Rissone, S. Gabasio, C. Zocchi, S. Randazzo, A. Crenna, P. Giannuzzi, E. Bonanomi, A. Mezzani, M. De Marchi, G. Begliuomini, C.A. Gianonatti, A. Gavazzi, A. Grosu, L. Dei Cas, S. Nodari, P. Garyfallidis, A. Bertoletti, C. Bonifazi, S. Arisi, F. Mascaro, M. Fraccarollo, S. Dell'Orto, M. Sfolcini, F. Bortolini, D. Raccagni, A. Turelli, M. Santarone, E. Miglierina, L. Sormani, R. Jemoli, F. Tettamanti, S. Pirelli, C. Bianchi, S. Verde, M. Mariani, V. Ziacchi, A. Ferrazza, A. Russo, M. Bortolotti, G.F. Pasini, A. Volpi, K.N. Jones, D. Cuzzucrea, G. Gullace, C. Carbone, A. Granata, S. De Servi, G. Del Rosso, C. Inserra, E. Renaldini, C. Zappa, M. Moretti, R. Zanini, M. Ferrari, E. Moroni, A. Cei, C. Lissi, E. Dovico, C. Fiorentini, P. Palermo, B. Brusoni, M. Negrini, J. Heyman, G.B. Danzi, A. Finzi, M. Frigerio, F. Turazza, L. Beretta, A. Sachero, F. Casazza, L. Squadroni, F. Lombardi, L. Marano, A. Margonato, G. Fragasso, O.C. Febo, E. Aiolfi, F. Olmetti, A. Grieco, V. Antonazzo, G. Specchia, A. Mortara, F. Robustelli, M.G. Songini, C. Schweiger, A. Frisinghelli, M. Palvarini, C. Campana, L. Scelsi, N. Ajmone Marsan, F. Cobelli, A. Gualco, C. Opasich, S. De Feo, R. Mazzucco, M.A. Iannone, T. Diaco, D. Zaniboni, G. Milanesi, D. Nassiacos, S. Meloni, P. Giani, T. Nicoli, C. Malinverni, A. Gusmini, L. Pozzoni, G. Bisiani, P. Margaroli, A. Schizzarotto, A. Daverio, G. Occhi, N. Partesana, P. Bandini, M.G. Rosella, S. Giustiniani, G. Cucchi, R. Pedretti, R. Raimondo, R. Vaninetti, A. Fedele, I. Ghezzi, E. Rezzonico, J.A. Salerno Uriarte, F. Morandi, F. Salvucci, C. Valenti, G. Graziano, M. Romanò, C. Cimminiello, I. Mangone, M. Lombardo, P. Quorso, G. Marinoni, M. Breghi, M. Erckert, A. Dienstl, G. Mirante Marini, C. Stefenelli, G. Cioffi, E. Buczkowska, A. Bonanome, F. Bazzanini, L. Parissenti, C. Serafini, G. Catania, L. Tarantini, G. Rigatelli, S. Boni, A. Pasini, E. Masini, A.A. Zampiero, M. Zanchetta, L. Franceschetto, P. Delise, C. Marcon, A. Sacchetta, L. Borgese, L. Artusi, P. Casolino, F. Corbara, A. Banzato, M. Barbiero, M.P. Aldegheri, R. Bazzucco, G. Crivellenti, A. Raviele, C. Zanella, P. Pascotto, P. Sarto, S. Milan, E. Barbieri, P. Girardi, W. Dalla Villa, J. Dalle Mule, M.L. Di Sipio, R. Cazzin, D. Milan, P. Zonzin, M. Carraro, R. Rossi, E. Carbonieri, I. Rossi, P. Stritoni, P. Meneghetti, G. Risica, P.L. Tenderini, C. Vassanelli, L. Zanolla, G. Perini, G. Brighetti, R. Chiozza, G. Giuliano, R. Gortan, R. Cesanelli, G.L. Nicolosi, R. Piazza, L. Mos, O. Vriz, D. Pavan, G. Pascottini, E. Alberti, M. Werren, L. Solinas, G. Sinagra, F. Longaro, P. Fioretti, M.C. Albanese, D. Miani, R. Gianrossi, A. Pende, P. Rubartelli, O. Magaia, S. Domenicucci, D. Caruso, A.S. Faraguti, L. Magliani, F. Miccoli, G. Guglielmino, D. Bertoli, A. Cantarelli, S. Orlandi, A. Vallebona, A. Pozzati, G. Brega, L.G. Pancaldi, R. Vandelli, S. Urbinati, M.G. Poci, M. Zoli, G.M. Costa, U. Guiducci, G. Zobbi, F. Tartagni, A. Tisselli, A. Gentili, P. Pieri, E. Cagnetta, S. Bendinelli, A. Barbieri, R. Conti, R. Ferrari, F. Merlini, A. Fucili, P. Moruzzi, E. Buia, M. Galvani, D. Ferrini, G. Baggioni, P. Yiannacopulu, G. Canè, A. Bonfiglioli, R. Zandomeneghi, L. Brugioni, A. Giannini, R. Di Ruvo, M. Giuliani, L. Rusconi, P. Del Corso, G. Piovaccari, F. Bologna, P. Venturi, F. Melandri, E. Bagni, L. Bolognese, R. Perticucci, A. Zuppiroli, M. Nannini, N. Consoli, P. Petrone, C. Pipitò, L. Colombi, D. Bernardi, P.R. Mariani, R. Testa, F. Mazzinghi, F. Cosmi, D. Cosmi, A. Zipoli, A. Cecchi, G. Castelli, M. Ciaccheri, F. Mori, F. Pieri, P. Valoti, D. Chiarantini, G.M. Santoro, C. Minneci, F. Marchi, M. Milli, G. Zambaldi, A.A. Brandinelli Geri, M. Cipriani, M. Alessandri, S. Severi, S. Stefanelli, A. Comella, R. Poddighe, A. Digiorgio, M. Carluccio, S. Berti, A. Rizza, V. Bonatti, V. Molendi, A. Brancato, N. D'Aprile, G. Giappichini, S. Del Vecchio, G. Mantini, F. De Tommasi, G. Meucci, M. Cordoni, S. Bechi, L. Barsotti, P. Baldini, M. Romei, G. Scopelliti, G. Lauri, F. Pestelli, F. Furiozzi, M. Cocchieri, D. Severini, F. Patriarchi, P. Chiocchi, M. Buccolieri, S. Martinelli, A. Wee, F. Angelici, M. Bernardinangeli, G. Proietti, B. Biscottini, R. Panciarola, L. Marinacci, G.P. Perna, D. Gabrielli, A. Moraca, L. Moretti, L. Partemi, G. Gregori, R. Amici, G. Patteri, P. Capone, E. Savini, G.L. Morgagni, L. Paccaloni, F. Pezzuoli, S. Carincola, S. Papi, S. De Crescentini, P. Gerardi, P. Midi, E. Gallenzi, G. Pajes, C. Mancone, V. Di Spirito, M. Di Gennaro, S. Calcagno, S. Toscano, S. Antonicoli, F. Carta, G. Giorgi, F. Comito, E. Daniele, O. Ciarla, P.G. Gelfo, A. Acquaviva, D. Testa, G. Testa, F.A. Pagliaro, F. Russo, F. Vetta, I. Marchese, G. Di Sciascio, A. D'Ambrosio, F. Leggio, D. Del Sindaco, A. Lacchè, A. Avallone, M.P. Risa, P. Azzolini, E. Baldo, E. Giovannini, G. Pulignano, C. Tondo, E. Picchio, E. ani, P. Tanzi, F. Pozzar, F. Farnetti, M. Azzarito, M. Santini, A. Varveri, G. Ferraiuolo, C. Valtorta, A. Gaspardone, G. Barbato, V. Ceci, N. Aspromonte, F. Bellocci, C. Colizzi, F. Fedele, F.I. Perez, A. Galati, A. Rossetti, A. Mainella, D. etta, C. Matteucci, G. Busi, A. De Angelis, G. Farina, A. Granatelli, F. Leone, F. Frasca, R. Di Giovambattista, G. Castellani, G. Massaro, G. Mastrogiuseppe, A. Vacri, F. De Sanctis, M. Cioli, S. Di Luzio, C. Napoletano, L.L. Piccioni, G. De Simone, A. Ottaviano, V. Mazza, C. Spedaliere, D. Staniscia, E. Calgione, G. De Marco, T. Chiacchio, T. Di Napoli, S. Romanzi, G. Salvatore, P. Golino, A. Palermo, F. Mascia, A. Vetrano, A. Vinciguerra, L. Caliendo, R. Longobardi, G. De Caro, R. Di Nola, F. Piemonte, D. Prinzi, P. De Rosa, V. De Rosa, F. Riello, V. Capuano, G. Vecchio, M. Landi, S. Amato, M. Garofalo, M. D'Avino, P. Sensale, O. Maiolica, R. Santoro, P. Caso, D. Miceli, N. Maurea, U. Bianchi, C. Crispo, M. Chiariello, P. Perrone Filardi, L. Russo, N. Capuano, G. Ungaro, G. Vergara, F. Scafuro, G. D'Angelo, C. Campaniello, P. Bottiglieri, A. Volpe, R. Battista, L. De Risi, G. Cardillo, G. Sibilio, A.P. Marino, F. Silvestri, P. Predotti, A. Iervoglini, C. De Matteis, P. Sarnicola, M.M. Matarazzo, S. Baldi, V. Iuliano, C. Astarita, P. Cuccaro, A. Liguori, G. Liguori, G. Gregorio, L. Petraglia, G. Antonelli, G. Amodio, I. De Luca, D. Traversa, G. Franchini, M.L. Lenti, D. Cavallari, C. D'Agostino, G. Scalera, C.M. Altamura, M. Russo, A.R. Mascolo, G. Pettinati, S.A. Ciricugno, D. Scrutinio, A. Passantino, D. Mastrangelo, A. Di Masi, R. De Carne, M. Cannone, F. Dibiase, M. Pensato, F. Loliva, F. Trapani, I. Panettieri, L. Leone, M. Di Biase, M. Carrone, V. Gallone, F. Cocco, M. Costantini, C. Tritto, F. Cavalieri, L. Stella, F. Magliari, M. Callerame, A. De Giorgi, L. Pellegrino, M. Correra, V. Portulano, G.L. Nisi, G. Grassi, E. Cristallo, D. De Laura, C. Salerno, R. Fanelli, M. Villella, S. Pede, A. Renna, E. De Lorenzi, L. Urso, V. Lenti, A. Peluso, N. Baldi, G. Polimeni, P. Palma, R. Lauletta, E. Tagliamonte, T. Cirillo, B. Silvestri, G. Centonze, B. D'Alessandro, L. Truncellito, D. Mecca, M.A. Petruzzi, R.O.M. Coviello, A. Lopizzo, M. telli, S. Barbuzzi, S. Gubelli, G. Germinario, N. Cosentino, A. Mingrone, R. Vico, G. Borrello, M.L. Mazza, R. Cimino, D. Galasso, F. Cassadonte, U. Talarico, F. Perticone, S. Cassano, F. Catapano, S. Calemme, E. Feraco, C. Cloro, G. Misuraca, R. Caporale, L. Vigna, V. Spagnuolo, F. De Rosa, G. Spadafora, G. Zampaglione, R. Russo, F.A. Schipani, A.F. Ferragina, D. Stranieri, G. Musca, C. Carpino, P. Bencardino, F. Raimondo, D. Musacchio, G. Pulitanò, A. Ruggeri, A. Provenzano, S. Salituri, M. Musolino, S. Calandruccio, A. Marrari, E. Tripodi, R. Scali, L. Anastasio, A. Arone, P. Aragona, L. Donnangelo, M.G.A. Comito, F. Bilotta, I. Vaccaro, R. Rametta, V. Ventura, A. Bonvegna, A. Alì, C. Cinnirella, M. Raineri, F. Pompeo, N. Cascio Ingurgio, V. Carini, R. Coco, G. Giunta, G. Leonardi, V. Randazzo, V. Di Blasi, C. Tamburino, G. Russo, S. Mangiameli, R. Cardillo, D. Castelli, V. Inserra, A. Arena, M.M. Gulizia, S. Raciti, G. Rapisarda, R. Romano, P. Prestifilippo, G.B. Braschi, G. Ledda, R. Terrazzino, M. De Caro, G. Scilabra, B. agnino, R. Grassi, G. Di Tano, G.F. Scimone, L. Vasquez, C. Coppolino, A. Casale, M. Castelli, G. D'Urso, E. D'Antonio, L. Lo Presti, E. Badalamenti, P. Conti, N. Sanfilippo, V. Cirrincione, M.T. Cinà, G. Cusimano, A. Taormina, P. Giuliano, A. Bajardi, V. Mandalà, A. Canonico, G. Geraci, F.P. Sabella, F. Enia, A.M. Floresta, I. Lo Cascio, D. Gumina, A. Cavallaro, G. Piccione, R. Ferrante, M. Blandino, M.S. Iudicello, E. Mossuti, G. Romano, L. Lombardo, P. Monastra, D. Di Vincenzo, M. Porcu, P. Orrù, F. Muscas, G. Giardina, M. Corda, G. Locci, A. Podda, M. Ledda, P. Siddi, C. Lai, G. Pili, G. Mercuro, G. Mureddu, A. Ganau, G. Meloni, G. Poddighe, G. Sanna, Dauriz, Marco, Targher, Giovanni, Temporelli, Pier Luigi, Lucci, Donata, Gonzini, Lucio, Nicolosi, Gian Luigi, Marchioli, Roberto, Tognoni, Gianni, Latini, Roberto, Cosmi, Franco, Tavazzi, Luigi, Maggioni, Aldo Pietro, on behalf of the GISSI-HF, Investigator, Margonato, Alberto, Moccetti, T., Rossi, M. G., Pasotti, E., Vaghi, F., Roncarolo, P., Zunino, M. T., Matta, F., Actis Perinetto, E., Gaita, F., Azzaro, G., Zanetta, M., Paino, A. M., Parravicini, U., Vegis, D., Conte, R., Ferraro, P., De Bernardi, A., Morelloni, S., Fagnani, M., Greco Lucchina, P., Montagna, L., Bellone, E., Sappè, D., Ferraro, F., Delucchi, M., Reynaud, S. G., Dore, M., La Brocca, A., Massobrio, N., Bo, L., Trinchero, R., Imazio, M., Brocchi, G., Nejrotti, A., Rissone, L., Gabasio, S., Zocchi, C., Randazzo, S., Crenna, A., Giannuzzi, P., Bonanomi, E., Mezzani, A., De Marchi, M., Begliuomini, G., Gianonatti, C. A., Gavazzi, A., Grosu, A., Dei Cas, L., Nodari, S., Garyfallidis, P., Bertoletti, A., Bonifazi, C., Arisi, S., Mascaro, F., Fraccarollo, M., Dell'Orto, S., Sfolcini, M., Bortolini, F., Raccagni, D., Turelli, A., Santarone, M., Miglierina, E., Sormani, L., Jemoli, R., Tettamanti, F., Pirelli, S., Bianchi, C., Verde, S., Mariani, M., Ziacchi, V., Ferrazza, A., Russo, A., Bortolotti, M., Pasini, G. F., Volpi, A., Jones, K. N., Cuzzucrea, D., Gullace, G., Carbone, C., Granata, A., De Servi, S., Del Rosso, G., Inserra, C., Renaldini, E., Zappa, C., Moretti, M., Zanini, R., Ferrari, M., Moroni, E., Cei, A., Lissi, C., Dovico, E., Fiorentini, C., Palermo, P., Brusoni, B., Negrini, M., Heyman, J., Danzi, G. B., Finzi, A., Frigerio, M., Turazza, F., Beretta, L., Sachero, A., Casazza, F., Squadroni, L., Lombardi, F., Marano, L., Margonato, A., Fragasso, G., Febo, O. C., Aiolfi, E., Olmetti, F., Grieco, A., Antonazzo, V., Specchia, G., Mortara, A., Robustelli, F., Songini, M. G., Schweiger, C., Frisinghelli, A., Palvarini, M., Campana, C., Scelsi, L., Ajmone Marsan, N., Cobelli, F., Gualco, A., Opasich, C., De Feo, S., Mazzucco, R., Iannone, M. A., Diaco, T., Zaniboni, D., Milanesi, G., Nassiacos, D., Meloni, S., Giani, P., Nicoli, T., Malinverni, C., Gusmini, A., Pozzoni, L., Bisiani, G., Margaroli, P., Schizzarotto, A., Daverio, A., Occhi, G., Partesana, N., Bandini, P., Rosella, M. G., Giustiniani, S., Cucchi, G., Pedretti, R., Raimondo, R., Vaninetti, R., Fedele, A., Ghezzi, I., Rezzonico, E., Salerno Uriarte, J. A., Morandi, F., Salvucci, F., Valenti, C., Graziano, G., Romanò, M., Cimminiello, C., Mangone, I., Lombardo, M., Quorso, P., Marinoni, G., Breghi, M., Erckert, M., Dienstl, A., Mirante Marini, G., Stefenelli, C., Cioffi, G., Buczkowska, E., Bonanome, A., Bazzanini, F., Parissenti, L., Serafini, C., Catania, G., Tarantini, L., Rigatelli, G., Boni, S., Pasini, A., Masini, E., Zampiero, A. A., Zanchetta, M., Franceschetto, L., Delise, P., Marcon, C., Sacchetta, A., Borgese, L., Artusi, L., Casolino, P., Corbara, F., Banzato, A., Barbiero, M., Aldegheri, M. P., Bazzucco, R., Crivellenti, G., Raviele, A., Zanella, C., Pascotto, P., Sarto, P., Milan, S., Barbieri, E., Girardi, P., Dalla Villa, W., Dalle Mule, J., Di Sipio, M. L., Cazzin, R., Milan, D., Zonzin, P., Carraro, M., Rossi, R., Carbonieri, E., Rossi, I., Stritoni, P., Meneghetti, P., Risica, G., Tenderini, P. L., Vassanelli, C., Zanolla, L., Perini, G., Brighetti, G., Chiozza, R., Giuliano, G., Baldin, M. G., Gortan, R., Cesanelli, R., Nicolosi, G. L., Piazza, R., Mos, L., Vriz, O., Pavan, D., Pascottini, G., Alberti, E., Werren, M., Solinas, L., Sinagra, G., Longaro, F., Fioretti, P., Albanese, M. C., Miani, D., Gianrossi, R., Pende, A., Rubartelli, P., Magaia, O., Domenicucci, S., Caruso, D., Faraguti, A. S., Magliani, L., Miccoli, F., Guglielmino, G., Bertoli, D., Cantarelli, A., Orlandi, S., Vallebona, A., Pozzati, A., Brega, G., Pancaldi, L. G., Vandelli, R., Urbinati, S., Poci, M. G., Zoli, M., Costa, G. M., Guiducci, U., Zobbi, G., Tartagni, F., Tisselli, A., Gentili, A., Pieri, P., Cagnetta, E., Bendinelli, S., Barbieri, A., Conti, R., Ferrari, R., Merlini, F., Fucili, A., Moruzzi, P., Buia, E., Galvani, M., Ferrini, D., Baggioni, G., Yiannacopulu, P., Canè, G., Bonfiglioli, A., Zandomeneghi, R., Brugioni, L., Giannini, A., Di Ruvo, R., Giuliani, M., Rusconi, L., Del Corso, P., Piovaccari, G., Bologna, F., Venturi, P., Melandri, F., Bagni, E., Bolognese, L., Perticucci, R., Zuppiroli, A., Nannini, M., Consoli, N., Petrone, P., Pipitò, C., Colombi, L., Bernardi, D., Mariani, P. R., Testa, R., Mazzinghi, F., Cosmi, F., Cosmi, D., Zipoli, A., Cecchi, A., Castelli, G., Ciaccheri, M., Mori, F., Pieri, F., Valoti, P., Chiarantini, D., Santoro, G. M., Minneci, C., Marchi, F., Milli, M., Zambaldi, G., Brandinelli Geri, A. A., Cipriani, M., Alessandri, M., Severi, S., Stefanelli, S., Comella, A., Poddighe, R., Digiorgio, A., Carluccio, M., Berti, S., Rizza, A., Bonatti, V., Molendi, V., Brancato, A., D'Aprile, N., Giappichini, G., Del Vecchio, S., Mantini, G., De Tommasi, F., Meucci, G., Cordoni, M., Bechi, S., Barsotti, L., Baldini, P., Romei, M., Scopelliti, G., Lauri, G., Pestelli, F., Furiozzi, F., Cocchieri, M., Severini, D., Patriarchi, F., Chiocchi, P., Buccolieri, M., Martinelli, S., Wee, A., Angelici, F., Bernardinangeli, M., Proietti, G., Biscottini, B., Panciarola, R., Marinacci, L., Perna, G. P., Gabrielli, D., Moraca, A., Moretti, L., Partemi, L., Gregori, G., Amici, R., Patteri, G., Capone, P., Savini, E., Morgagni, G. L., Paccaloni, L., Pezzuoli, F., Carincola, S., Papi, S., De Crescentini, S., Gerardi, P., Midi, P., Gallenzi, E., Pajes, G., Mancone, C., Di Spirito, V., Di Gennaro, M., Calcagno, S., Toscano, S., Antonicoli, S., Carta, F., Giorgi, G., Comito, F., Daniele, E., Ciarla, O., Gelfo, P. G., Acquaviva, A., Testa, D., Testa, G., Pagliaro, F. A., Russo, F., Vetta, F., Marchese, I., Di Sciascio, G., D'Ambrosio, A., Leggio, F., Del Sindaco, D., Lacchè, A., Avallone, A., Risa, M. P., Azzolini, P., Baldo, E., Giovannini, E., Pulignano, G., Tondo, C., Picchio, E., Biffani, E., Tanzi, P., Pozzar, F., Farnetti, F., Azzarito, M., Santini, M., Varveri, A., Ferraiuolo, G., Valtorta, C., Gaspardone, A., Barbato, G., Ceci, V., Aspromonte, N., Bellocci, F., Colizzi, C., Fedele, F., Perez, F. I., Galati, A., Rossetti, A., Mainella, A., Ciuffetta, D., Matteucci, C., Busi, G., De Angelis, A., Farina, G., Granatelli, A., Leone, F., Frasca, F., Di Giovambattista, R., Castellani, G., Massaro, G., Mastrogiuseppe, G., Vacri, A., De Sanctis, F., Cioli, M., Di Luzio, S., Napoletano, C., Piccioni, L. L., De Simone, G., Ottaviano, A., Mazza, V., Spedaliere, C., Staniscia, D., Calgione, E., De Marco, G., Chiacchio, T., Di Napoli, T., Romanzi, S., Salvatore, G., Golino, P., Palermo, A., Mascia, F., Vetrano, A., Vinciguerra, A., Caliendo, L., Longobardi, R., De Caro, G., Di Nola, R., Piemonte, F., Prinzi, D., De Rosa, P., De Rosa, V., Riello, F., Capuano, V., Vecchio, G., Landi, M., Amato, S., Garofalo, M., D'Avino, M., Sensale, P., Maiolica, O., Santoro, R., Caso, P., Miceli, D., Maurea, N., Bianchi, U., Crispo, C., Chiariello, M., Perrone Filardi, P., Russo, L., Capuano, N., Ungaro, G., Vergara, G., Scafuro, F., D'Angelo, G., Campaniello, C., Bottiglieri, P., Volpe, A., Battista, R., De Risi, L., Cardillo, G., Sibilio, G., Marino, A. P., Silvestri, F., Predotti, P., Iervoglini, A., De Matteis, C., Sarnicola, P., Matarazzo, M. 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Subjects
Blood Glucose, Male, Glycated Hemoglobin A, heart failure, Kaplan-Meier Estimate, prediabetes, 030204 cardiovascular system & hematology, time factors, Settore MED/11, cause of death, 0302 clinical medicine, Glycemic control, prediabetic state, Cause of Death, italy, middle aged, Prevalence, 80 and over, double-blind method, blood glucose, risk factors, 030212 general & internal medicine, Prediabetes, Rosuvastatin Calcium, humans, rosuvastatin calcium, Cause of death, Original Research, Metabolic Syndrome, Aged, 80 and over, adult, Chronic heart failure, Diabetes mellitus, Heart failure, Mortality, Cardiology and Cardiovascular Medicine, Hazard ratio, chronic heart failure, diabetes mellitus, glycemic control, mortality, Treatment Outcome, Adolescent, Biomarkers, Chronic Disease, Diabetes Mellitus, Fatty Acids, Omega-3, Double-Blind Method, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Hospitalization, Heart Failure, Italy, Prediabetic State, Risk Assessment, Proportional Hazards Models, Risk Factors, Time Factors, risk assessment, Middle Aged, kaplan-meier estimate, aged, female, Prediabete, young adult, Female, omega-3, Human, hospitalization, Adult, medicine.medical_specialty, Diabetes mellitu, proportional hazards models, Time Factor, hydroxymethylglutaryl-coa reductase inhibitors, prevalence, fatty acids, 03 medical and health sciences, Young Adult, male, Internal medicine, Post-hoc analysis, glycated hemoglobin a, medicine, Intensive care medicine, Aged, Glycated Hemoglobin, Proportional hazards model, business.industry, Risk Factor, biomarkers, Biomarker, medicine.disease, Clinical trial, adolescent, Proportional Hazards Model, treatment outcome, aged, 80 and over, chronic disease, fatty acids, omega-3, cardiology and cardiovascular medicine, Hydroxymethylglutaryl-CoA Reductase Inhibitor, business
Abstract

Background The independent prognostic impact of diabetes mellitus ( DM ) and prediabetes mellitus (pre‐ DM ) on survival outcomes in patients with chronic heart failure has been investigated in observational registries and randomized, clinical trials, but the results have been often inconclusive or conflicting. We examined the independent prognostic impact of DM and pre‐ DM on survival outcomes in the GISSI ‐HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca‐Heart Failure) trial. Methods and Results We assessed the risk of all‐cause death and the composite of all‐cause death or cardiovascular hospitalization over a median follow‐up period of 3.9 years among the 6935 chronic heart failure participants of the GISSI ‐ HF trial, who were stratified by presence of DM (n=2852), pre‐ DM (n=2013), and non‐ DM (n=2070) at baseline. Compared with non‐ DM patients, those with DM had remarkably higher incidence rates of all‐cause death (34.5% versus 24.6%) and the composite end point (63.6% versus 54.7%). Conversely, both event rates were similar between non‐ DM patients and those with pre‐ DM . Cox regression analysis showed that DM , but not pre‐ DM , was associated with an increased risk of all‐cause death (adjusted hazard ratio, 1.43; 95% CI , 1.28–1.60) and of the composite end point (adjusted hazard ratio, 1.23; 95% CI , 1.13–1.32), independently of established risk factors. In the DM subgroup, higher hemoglobin A1c was also independently associated with increased risk of both study outcomes (all‐cause death: adjusted hazard ratio, 1.21; 95% CI , 1.02–1.43; and composite end point: adjusted hazard ratio, 1.14; 95% CI , 1.01–1.29, respectively). Conclusions Presence of DM was independently associated with poor long‐term survival outcomes in patients with chronic heart failure. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 00336336.

Published
2017
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