1. A prospective study comparing the repeatability and sensitivity to change of non-invasive endpoints in pulmonary arterial hypertension: the RESPIRE study
- Author
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Allan Lawrie, Jim M. Wild, Matthew Austin, Marcella Cogliano, Tony Kahn, Dave Capener, Peter M. Hickey, Fred Wilson, Robin Condliffe, Charlotte Oram, Alexander M.K. Rothman, Andrew J. Swift, Lindsay Kendall, Pankaj Garg, David G. Kiely, Christopher S. Johns, and J Pickworth
- Subjects
medicine.medical_specialty ,medicine.diagnostic_test ,Intraclass correlation ,business.industry ,Non invasive ,Repeatability ,Right ventricular ejection fraction ,03 medical and health sciences ,0302 clinical medicine ,030228 respiratory system ,Cardiac magnetic resonance imaging ,Internal medicine ,Cardiology ,medicine ,In patient ,030212 general & internal medicine ,Sensitivity to change ,Prospective cohort study ,business - Abstract
Introduction: For clinical trials it is important to know the repeatability and sensitivity to change of study end-points. The aim of this study was to compare non-invasive candidate end-points in patients with pulmonary arterial hypertension (PAH). Methods: We examined 2 field walking tests: the six minute walk test (6MWT) and the incremental shuttle walking test (ISWT) and 2 tests of RV function: NT-proBNP and cardiac magnetic resonance imaging (cMRI). Patients with PAH underwent 6MWT, ISWT, NT-proBNP and cMRI (visit 1). At follow-up at around 6 months the investigations were repeated x2 within 24 hours (visits 2 and 3). Test-retest repeatability (visits 2 vs 3) and change with therapy (visit 2 minus visit 1) were assessed by the intraclass correlation coefficient (ICC) and a paired t-test respectively. Results: Of 44 patients, 40 completed the study; 27 patients underwent initiation or escalation of PAH therapy and 13 were stable on therapy. For all patients the ICC for the ISWT was 0.99, 6MWT 0.99, NT-proBNP 0.72, right ventricular end-systolic volume (RVESV) 0.98 and right ventricular ejection fraction (RVEF) 0.83. Following initiation or escalation of therapy there was an increase in ISWT, mean difference +40m (standard deviation (SD) 79), p=0.02 and 6MWT distance, +35m (SD 79) p=0.04, a reduction in RVESV -20ml (SD 30) p=0.002, and an increase in RVEF, +4% (SD 9), p=0.04 respectively. There was no significant change in NT-proBNP, -206 pg/m (SD 684), p=0.15. Conclusion: ISWT and 6MWT had excellent repeatability and are sensitive to change in PAH. CMRI but not NT-proBNP has excellent repeatability and is sensitive to change.
- Published
- 2019
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