Guidelines for Translational Research in Heart Failure

被引:24
|
作者
Lara-Pezzi, Enrique [1 ]
Menasche, Philippe [2 ]
Trouvin, Jean-Hugues [3 ,4 ]
Badimon, Lina [5 ]
Ioannidis, John P. A. [6 ,7 ]
Wu, Joseph C. [8 ]
Hill, Joseph A. [9 ,15 ]
Koch, Walter J. [10 ]
De Felice, Albert F. [11 ]
de Waele, Peter [12 ]
Steenwinckel, Valerie [12 ]
Hajjar, Roger J. [13 ]
Zeiher, Andreas M. [14 ]
机构
[1] CNIC, Cardiovasc Dev & Repair Dept, Madrid 28029, Spain
[2] Hop Europeen Georges Pompidou, AP HP, Dept Cardiovasc Surg, Paris, France
[3] Univ Paris Sorbonne Cite, Sch Pharm, Dept Hlth Secur & Publ Hlth, Paris, France
[4] European Med Agcy, Comm Adv Therapies, London, England
[5] Hosp Santa Creu & Sant Pau, IIB St Pau, Cardiovasc Res Ctr, CSIC,ICCC, Barcelona, Spain
[6] Stanford Univ, Dept Med, Stanford Prevent Res Ctr, Stanford, CA 94305 USA
[7] Stanford Univ, Dept Hlth Res & Policy, Div Epidemiol, Stanford, CA 94305 USA
[8] Stanford Univ, Sch Med, Stanford Cardiovasc Inst, Stanford, CA 94305 USA
[9] Univ Texas SW Med Ctr Dallas, Dept Internal Med Cardiol, Dallas, TX 75390 USA
[10] Temple Univ, Dept Pharmacol, Ctr Translat Med, Philadelphia, PA 19122 USA
[11] US FDA, Div Cardiovasc Drug Prod, Silver Spring, MD USA
[12] Cardio3 BioSci SA, Mt St Guibert, France
[13] Mt Sinai Sch Med, Dept Cardiol, Cardiovasc Res Ctr, New York, NY USA
[14] JW Goethe Univ Hosp Frankfurt, Dept Cardiol, Internal Med 3, Frankfurt, Germany
[15] Univ Texas SW Med Ctr Dallas, Dept Mol Biol, Dallas, TX 75390 USA
关键词
Guidelines; Heart failure; Animal models; New therapies; Preclinical studies; Clinical trials; Good laboratory practice; Induced pluripotent stem cells; Toxicity; IMPROVES CARDIAC-FUNCTION; DE-POINTES ARRHYTHMIAS; PLURIPOTENT STEM-CELLS; MYOCARDIAL-INFARCTION; MAGNETIC-RESONANCE; EJECTION FRACTION; ANIMAL-MODELS; AMERICAN-SOCIETY; BLOOD-PRESSURE; BASIC SCIENCE;
D O I
10.1007/s12265-015-9606-8
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Heart failure (HF) remains a major cause of death and hospitalization worldwide. Despite medical advances, the prognosis of HF remains poor and new therapeutic approaches are urgently needed. The development of new therapies for HF is hindered by inappropriate or incomplete preclinical studies. In these guidelines, we present a number of recommendations to enhance similarity between HF animal models and the human condition in order to reduce the chances of failure in subsequent clinical trials. We propose different approaches to address safety as well as efficacy of new therapeutic products. We also propose that good practice rules are followed from the outset so that the chances of eventual approval by regulatory agencies increase. We hope that these guidelines will help improve the translation of results from animal models to humans and thereby contribute to more successful clinical trials and development of new therapies for HF.
引用
收藏
页码:3 / 22
页数:20
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