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2. Optimal Screening for Predicting and Preventing the Risk of Heart Failure Among Adults With Diabetes Without Atherosclerotic Cardiovascular Disease: A Pooled Cohort Analysis

Author

Patel, Kershaw V., Segar, Matthew W., Klonoff, David C., Khan, Muhammad Shahzeb, Usman, Muhammad Shariq, Lam, Carolyn S.P., Verma, Subodh, DeFilippis, Andrew P., Nasir, Khurram, Bakker, Stephan J.L., Westenbrink, B. Daan, Dullaart, Robin P.F., Butler, Javed, Vaduganathan, Muthiah, and Pandey, Ambarish

Published
2024
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3. Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF Trial

Author

Kosiborod, Mikhail N., Verma, Subodh, Borlaug, Barry A., Butler, Javed, Davies, Melanie J., Jon Jensen, Thomas, Rasmussen, Søren, Erlang Marstrand, Peter, Petrie, Mark C., Shah, Sanjiv J., Ito, Hiroshi, Schou, Morten, Melenovský, Vojtěch, Abhayaratna, Walter, and Kitzman, Dalane W.

Published
2024
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17. Abstract 12936: Quality of Life Assessments as Inclusion Criteria in Heart Failure Clinical Trials

Author

Dimond, Matthew, Khan, Mohammad S, Fiuzat, Mona, Cleland, John G, Bhatt, Ankeet, Psotka, Mitchell, Anker, Stefan D, Butler, Javed, Felker, Michael, Mark, Daniel B, Carson, Peter E, Abraham, William T, Ahmad, Tariq, Lindenfeld, Joann, Vaduganathan, Muthiah, Whellan, David J, Vardeny, Orly, Solomon, Scott, Lewis, Eldrin F, Filippatos, Gerasimos, and OConnor, Christopher M

Published
2023
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21. Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Author

Butler, Javed, Packer, Milton, Greene, Stephen J, Fiuzat, Mona, Anker, Stefan D, Anstrom, Kevin J, Carson, Peter E, Cooper, Lauren B, Fonarow, Gregg C, Hernandez, Adrian F, Januzzi, James L, Jessup, Mariell, Kalyani, Rita R, Kaul, Sanjay, Kosiborod, Mikhail, Lindenfeld, JoAnn, McGuire, Darren K, Sabatine, Marc S, Solomon, Scott D, Teerlink, John R, Vaduganathan, Muthiah, Yancy, Clyde W, Stockbridge, Norman, and O'Connor, Christopher M

Subjects
Cardiovascular, Clinical Trials and Supportive Activities, Clinical Research, Heart Disease, Heart Disease - Coronary Heart Disease, Diabetes, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, 5.1 Pharmaceuticals, Development of treatments and therapeutic interventions, Cardiovascular Diseases, Clinical Trials as Topic, Diabetes Mellitus, Type 2, Endpoint Determination, Heart Failure, Humans, Research Report, Sodium-Glucose Transporter 2, Sodium-Glucose Transporter 2 Inhibitors, Treatment Outcome, biomarkers, clinical trial, diabetes mellitus, type 2, heart failure, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycemic medications on the primary end point of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Heart failure (HF) was not specifically mentioned in the US Food and Drug Administration guidance and therefore it was not a focus of these studies when planned. Several trials subsequently showed the impact of antihyperglycemic drugs on HF outcomes, which were not originally specified as the primary end point of the trials. The most impressive finding has been the substantial and consistent risk reduction in HF hospitalization seen across 4 trials of sodium glucose cotransporter 2 inhibitors. However, to date, these results have not led to regulatory approval of any of these drugs for a HF indication or a recommendation for use by US HF guidelines. It is therefore important to explore to what extent persuasive treatment effects on nonprimary end points can be used to support regulatory claims and guideline recommendations. This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019. This report summarizes these discussions and the key takeaway messages from this meeting.

Published
2019

22. Association Between Hemoglobin Levels and Efficacy of Intravenous Ferric Carboxymaltose in Patients With Acute Heart Failure and Iron Deficiency: An AFFIRM-AHF Subgroup Analysis

Author

Filippatos, Gerasimos, Ponikowski, Piotr, Farmakis, Dimitrios, Anker, Stefan D., Butler, Javed, Fabien, Vincent, Kirwan, Bridget-Anne, Macdougall, Iain C., Metra, Marco, Rosano, Giuseppe, Ruschitzka, Frank, van der Meer, Peter, Waechter, Sandra, and Jankowska, Ewa A.

Published
2023
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23. Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified Analyses From the REVIVED-BCIS2 Trial

Author

Perera, Divaka, Morgan, Holly P., Ryan, Matthew, Dodd, Matthew, Clayton, Tim, O’Kane, Peter D., Greenwood, John P., Walsh, Simon J., Weerackody, Roshan, McDiarmid, Adam, Amin-Youssef, George, Strange, Julian, Modi, Bhavik, Lockie, Timothy, Hogrefe, Kai, Ahmed, Fozia Z., Behan, Miles, Jenkins, Nicholas, Abdelaal, Eltigani, Anderson, Michelle, Watkins, Stuart, Evans, Richard, Rinaldi, Christopher A., Petrie, Mark C., Perera, Divaka, Chiribiri, Amedeo, Carr-White, Gerry, Pavlidis, Antonis, Redwood, Simon, Clapp, Brian, Rinaldi, Aldo, Rahman, Haseeb, Briceno, Natalia, Arnold, Sophie, Raynsford, Amy, Wilson, Karen, Clack, Lucy, Petrie, Mark, McEntegart, Margaret, Watkins, Stuart, Shaukat, Aadil, Rocchiccioli, Paul, McAdam, Marion, McPherson, Elizabeth, Cowan, Louise, Wood, Marie, Weerackody, Roshan, Davies, Ceri, Smith, Elliot, Modi, Bhavik, Mathew, Bindu, Mitchelmore, Oliver, Adrego, Rita, Andiapen, Mervyn, O’Kane, Peter, Din, Jehangir, Kennard, Sarah, Orr, Sarah, Purnell, Cathie, Greenwood, John, Blaxill, Jonathan, Mozid, Abdul, Anderson, Michelle, Somers, Kathryn, Dixon, Lana, Walsh, Simon, Spence, Mark, Glover, Patricia, Brown, Caroline, Edwards, Richard, McDiarmid, Adam, Egred, Mohaned, Narytnyk, Alla, Wealleans, Vera, Amin-Youssef, George, Shah, Ajay, McDonagh, Theresa, Byrne, Jonathan, Pareek, Nilesh, Breeze, Jonathan, Antao, Catherine, De Silva, Kalpa, Strange, Julian, Johnson, Tom, Nightingale, Angus, Gallego, Laura, Medina, Cristina, Gershlick, Anthony, McCann, Gerald, Ladwiniec, Andrew, Squire, Iain, Davison, Joanna, Kenmuir-Hogg, Kris, Spratt, James, Cosgrove, Claudia, Williams, Rupert, Firoozi, Sam, Lim, Pitt, Bonato, Giovanna, Sookhoo, Vennessa, Conway, Dwayne, Brooksby, Paul, Wright, Judith, Exley, Donna, Cotton, James, Horton, Richard, Metherell, Stella, Smallwood, Andrew, Hogrefe, Kai, Cheng, Adrian, Beirnes, Charmaine, Sidgwick, Sian, Lockie, Tim, Patel, Niket, Rakhit, Roby, Davies, Nina, Smit, Angelique, Ahmed, Fozia, Hendry, Cara, Fath-Odoubadi, Farzin, Fraser, Douglas, Mamas, Mamas, Oommen, Anu, Charles, Thabitha, Behan, Miles, Japp, Alan, Rif, Belinda, Jenkins, Nicholas, McClure, Sam, Oates, Pauline, Martin, Karen, Abdelaal, Eltigani, Sarma, Jaydeep, Shastri, Sanjay, Riley, Jo, Giannopoulou, Sarra, Quinn, Sophie, Magapu, Pradeep, Stables, Rod, Wright, David, Barton, Janet, Clarkson, Nichola, Mahmoudi, Michael, Flett, Andrew, Curzen, Nick, Radmore, Judith, Gough, Sam, Ludman, Andrew, Kurdi, Hibba, Keenan, Samantha, Banerjee, Prithwish, Tapp, Luke, Edwards, Nigel, Gibson, Catherine, Kukreja, Neville, Lynch, Mary, Barratt, Claire, de Belder, Mark, Thambyrajah, Jeet, Swanson, Neil, Richardson, Cath, Atkinson, Bev, Viswanathan, Girish, Waugh, Darren, Routledge, Helen, Trevelyan, Jasper, Doughty, Angela, Pegge, Nick, Dhamrait, Sukhbir, Moore, Sally, Galasko, Gavin, Cassidy, Christopher, Waddington, Natalia, Edwards, Tim, Iqbal, Javed, Witherow, Fraser, Birch, Jenny, Munro, Melanie, Wells, Tim, Sinha, Manas, Frost, Linda, Lee, Kaeng, Beattie, James, Pitt, Mike, Chung, Alan, Ramcharitar, Steve, McCafferty, Laura, Martin, Thomas, Irving, John, Iskandar, Zaid, Hutcheon, Anita, Gunn, Julian, Al-Mohammad, Abdallah, Agyemang, Michael, Griffiths, Huw, Kalra, Paul, Howe, Serena, Gray, Tim, Sobolewska, Jolanta, Morby, Louise, Glover, Jason, Beynon, James, Knight, Janet, Das, Paul, Bellamy, Chris, Harman, Emily, Pye, Maurice, Megarry, Simon, McGill, Yvonne, and Redfearn, Heidi

Published
2023
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26. Empagliflozin and Left Ventricular Remodeling in People Without Diabetes: Primary Results of the EMPA-HEART 2 CardioLink-7 Randomized Clinical Trial

Author

Connelly, Kim A., Mazer, C. David, Puar, Pankaj, Teoh, Hwee, Wang, Chao-Hung, Mason, Tamique, Akhavein, Farhad, Chang, Ching-Wen, Liu, Min-Hui, Yang, Ning-I, Chen, Wei-Siang, Juan, Yu-Hsiang, Opingari, Erika, Salyani, Yaseen, Barbour, William, Pasricha, Aryan, Ahmed, Shamon, Kosmopoulos, Andrew, Verma, Raj, Moroney, Michael, Bakbak, Ehab, Krishnaraj, Aishwarya, Bhatt, Deepak L., Butler, Javed, Kosiborod, Mikhail N., Lam, Carolyn S.P., Hess, David A., Coelho-Filho, Otavio Rizzi, Lafreniere-Roula, Myriam, Thorpe, Kevin E., Quan, Adrian, Leiter, Lawrence A., Yan, Andrew T., and Verma, Subodh

Published
2022
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28. Reassessing the Role of Surrogate End Points in Drug Development for Heart Failure

Author

Greene, Stephen J, Mentz, Robert J, Fiuzat, Mona, Butler, Javed, Solomon, Scott D, Ambrosy, Andrew P, Mehta, Cyrus, Teerlink, John R, Zannad, Faiez, and O'Connor, Christopher M

Subjects
Clinical Trials and Supportive Activities, Cardiovascular, Clinical Research, Heart Disease, Cardiovascular Agents, Clinical Trials, Phase II as Topic, Consensus, Drug Development, Endpoint Determination, Heart Failure, Humans, Research Design, Treatment Outcome, biomarkers, clinical trial, drug discovery, endpoint determination, heart failure, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

With few notable exceptions, drug development for heart failure (HF) has become progressively more challenging, and there remain no definitively proven therapies for patients with acute HF or HF with preserved ejection fraction. Inspection of temporal trends suggests an increasing rate of disagreement between early-phase and phase III trial end points. Preliminary results from phase II HF trials are frequently promising, but increasingly followed by disappointing phase III results. Given this potential disconnect, it is reasonable to carefully re-evaluate the purpose, design, and execution of phase II HF trials, with particular attention directed toward the surrogate end points commonly used by these studies. In this review, we offer a critical reappraisal of the role of phase II HF trials and surrogate end points, highlighting challenges in their use and interpretation, lessons learned from past experiences, and specific strengths and weaknesses of various surrogate outcomes. We conclude by proposing a series of approaches that should be considered for the goal of optimizing the efficiency of HF drug development. This review is based on discussions between scientists, clinical trialists, industry and government sponsors, and regulators that took place at the Cardiovascular Clinical Trialists Forum in Washington, DC, on December 2, 2016.

Published
2018

29. Availability and Use of Shared Data From Cardiometabolic Clinical Trials

Author

Vaduganathan, Muthiah, Nagarur, Amulya, Qamar, Arman, Patel, Ravi B, Navar, Ann Marie, Peterson, Eric D, Bhatt, Deepak L, Fonarow, Gregg C, Yancy, Clyde W, and Butler, Javed

Subjects
Cardiovascular, Clinical Research, Clinical Trials and Supportive Activities, Prevention, Good Health and Well Being, Access to Information, Cardiovascular Diseases, Clinical Trials as Topic, Europe, Heart, Humans, Information Dissemination, Myocardium, North America, Outcome and Process Assessment, Health Care, Research Support as Topic, clinical trial, information dissemination, outcome and process assessment, research design, Cardiorespiratory Medicine and Haematology, Clinical Sciences, Public Health and Health Services, Cardiovascular System & Hematology
Abstract

BackgroundSharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials.MethodsWe extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies.ResultsFrom January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%). They covered 74 therapies and 398 925 patients. Diabetes mellitus (60%) and hypertension (15%) were the most common study topics. Median time from study completion to data availability was 79 months. As of May 2017, ClinicalStudyDataRequest.com had received 318 submitted proposals, of which 163 had signed data-sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 79 unique studies (15% of all trials, 29% of phase 3/4 trials). Most (96%) data requesters of cardiometabolic clinical trial data were from academic centers in North America and Western Europe, and half the proposals were unfunded. Most proposals were for secondary hypothesis-generating questions, with only 1 proposed reanalysis of the original study primary hypothesis. To date, 3 peer-reviewed articles have been published after a median of 19 months (9-32 months) from the data-sharing agreement.ConclusionsDespite availability of data from >500 cardiometabolic trials in a multisponsor data-sharing platform, only 15% of these trials and 29% of phase 3/4 trials have been accessed by investigators thus far, and a negligible minority of analyses have reached publication.

Published
2018

35. Abstract 14862: Development and Validation of a Phenomapping Tool to Identify Patients With Diuretic Resistance in Acute Decompensated Heart Failure: A Multi-Cohort Analysis

Author

Segar, Matthew W, Khan, Mohammad S, Patel, Kershaw, Butler, Javed, Ravichandran, Ashwin, Ravichandran, Ashwin, Walsh, Mary N, Willett, Duwayne, Fonarow, Gregg C, Drazner, Mark H, Mentz, Robert J, Hall, Jennifer L, Farr, MaryJane, Hedayati, Susan, Yancy, Clyde W, Allen, Larry A, Tang, Wai Hong W, and Pandey, Ambarish

Published
2022
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43. Abstract 13513: Favorable Neighborhood Walkability is Associated With Lower Burden of CV Risk Factors Among Patients Within an Integrated Health System: Houston Methodist CVD Learning Health System Registry

Author

Makram, Omar M, Nwana, Nwabunie, Nicolas, Charlie, Pan, Alan P, Gullapelli, Rakesh, BOSE, BUDHADITYA, Hagan, Kobina, Parekh, Tarang, Yahya, Tamer, Javed, Zulqarnain, Patel, Kershaw, Al-Kindi, Sadeer, Sharma, Garima, Jones, Stephen, Cainzos, Miguel, Maddock, Jay E, and Nasir, Khurram

Published
2022
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