Rationale and design of a randomized trial on the impact of aldosterone antagonism on cardiac structure and function in diabetic cardiomyopathy

Cardiovascular Diabetology

Study Protocol

Melissa Leung¹  Vincent W Wong²  Stephane Heritier³ 

[1] Department of Cardiology, Liverpool Hospital, Locked Bag 7103, 1871, Liverpool BC, NSW, Australia;University of New South Wales, Sydney, Australia;Diabetes and Endocrine Service, Liverpool Hospital, Sydney, Australia;University of New South Wales, Sydney, Australia;Cardiovascular & Hormonal Research Laboratory, Department of Cardiology, Kolling Institute of Medical Research, Royal North Shore Hospital & University of Sydney, Australia, Sydney;The George Institute, University of Sydney, Sydney, Australia;

关键词: Diabetes;    Heart failure;    Left ventricular function;    Echocardiography;    Collagen;    Aldosterone antagonism;   

DOI  :  10.1186/1475-2840-12-139

 received in 2013-07-16, accepted in 2013-09-21,  发布年份 2013

来源: Springer

【 摘 要 】

Development of a cardiomyopathy in diabetes mellitus is independent of traditional risk factors, with no clinical trials targeting specific therapeutic interventions. Myocardial fibrosis is one of the key mechanisms and aldosterone is a key mediator of myocardial fibrosis. We propose that aldosterone antagonism will improve cardiac function. We aim to evaluate the efficacy of selective aldosterone receptor antagonism with eplerenone added to optimal medical treatment in improving cardiac structure and function in diabetic cardiomyopathy. We will randomize 130 patients with type 2 diabetes mellitus, stable metabolic control and impaired left ventricular (LV) systolic or diastolic function, to either eplerenone (target dose 50mg) or matching placebo, in addition to optimal medical therapy for 12 months. The primary endpoints are changes in LV systolic and diastolic function, measured by echocardiographic 2-dimensional speckle tracking strain and strain rate and tissue Doppler imaging. The secondary endpoints include changes in echocardiographic markers and plasma biomarkers of collagen turnover; left atrial dimensions and function, incidence of atrial fibrillation and changes in exercise capacity and dyspnea score. The present study will assess whether specific aldosterone antagonism with eplerenone in addition to standard therapy will prevent progression or reverse cardiac dysfunction in diabetic cardiomyopathy using sensitive, robust and quantifiable echocardiographic measures that allow early detection of change. The study may offer a new direction in the management of this condition.Trial registrationACTRN12610001063000

【 授权许可】

CC BY   
© Leung et al.; licensee BioMed Central Ltd. 2013