Agents with vasodilator properties in acute heart failure: how to design successful trials

Autor: Mebazaa, Alexandre, Longrois, Dan, Metra, Marco, Mueller, Christian, Richards, Arthur Mark, Roessig, Lothar, Seronde, Marie France, Sato, Naoki, Stockbridge, Norman, Gattis Stough, Wendy, Alonso, Angeles, Cody, Robert, Cook Bruns, Nancy, Gheorghiade, Mihai, Holzmeister, Johannes, Laribi, Said, Zannad, Faiez
Přispěvatelé: Department of anesthesiology and intensive care, Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand-Widal, Université Paris Diderot - Paris 7 (UPD7), Biomarqueurs CArdioNeuroVASCulaires (BioCANVAS), Université Paris 13 (UP13)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'anesthésie - réanimation chirurgicale [CHU Bichat], Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris]-Université Paris Diderot - Paris 7 (UPD7), Laboratoire de Recherche Vasculaire Translationnelle (LVTS (UMR_S_1148 / U1148)), Università degli Studi di Brescia [Brescia], University Hospital Basel [Basel], National University of Singapore (NUS), Bayer Pharma AG [Berlin], Service de cardiologie, Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon), Nippon Medical School [Tokyo, Japan], U.S. Food and Drug Administration (FDA), Campbell University College, Scientific Advice Working Party European Medicines Agency, Janssen Research & Development, Feinberg Cardiovascular Research Institute, Northwestern University School of Medicine, Cardiorentis AG, Département de Médecine d'Urgence [AP-HP Hôpitaux universitaires Saint-Louis, Lariboisière, Fernand-Widal], AP-HP Hôpitaux universitaires Saint-Louis, Lariboisière, Fernand-Widal, Centre d'investigation clinique plurithématique Pierre Drouin (CIC-P), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Service de Cardiologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Défaillance Cardiovasculaire Aiguë et Chronique (DCAC), Université de Lorraine (UL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre d'investigation clinique plurithématique Pierre Drouin [Nancy] (CIC-P), Centre d'investigation clinique [Nancy] (CIC), Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Zdroj: European Journal of Heart Failure
European Journal of Heart Failure, Oxford University Press (OUP), 2015, 17 (7), pp.652-664. ⟨10.1002/ejhf.294⟩
ISSN: 1388-9842
DOI: 10.1002/ejhf.294⟩
Popis: International audience; Agents with vasodilator properties (AVDs) are frequently used in the treatment of acute heart failure (AHF). AVDs rapidly reduce preload and afterload, improve left ventricle to aorta and right ventricle to pulmonary artery coupling, and may improve symptoms. Early biomarker changes after AVD administration have suggested potentially beneficial effects on cardiac stretch, vascular tone, and renal function. AVDs that reduce haemodynamic congestion without causing hypoperfusion might be effective in preventing worsening organ dysfunction. Existing AVDs have been associated with different results on outcomes in randomized clinical trials, and observational studies have suggested that AVDs may be associated with a clinical outcome benefit. Lessons have been learned from past AVD trials in AHF regarding preventing hypotension, selecting the optimal endpoint, refining dyspnoea measurements, and achieving early randomization and treatment initiation. These lessons have been applied to the design of ongoing pivotal clinical trials, which aim to ascertain if AVDs improve clinical outcomes. The developing body of evidence suggests that AVDs may be a clinically effective therapy to reduce symptoms, but more importantly to prevent end-organ damage and improve clinical outcomes for specific patients with AHF. The results of ongoing trials will provide more clarity on the role of AVDs in the treatment of AHF.
Databáze: OpenAIRE
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