Document Detail


Rationale and design of the 'aldosterone receptor blockade in diastolic heart failure' trial: a double-blind, randomized, placebo-controlled, parallel group study to determine the effects of spironolactone on exercise capacity and diastolic function in patients with symptomatic diastolic heart failure (Aldo-DHF).
MedLine Citation:
PMID:  20538867     Owner:  NLM     Status:  In-Process    
Abstract/OtherAbstract:
AIMS: Increasing evidence suggests that enhanced aldosterone signalling plays a key role in the onset and progression of diastolic heart failure (DHF). Aldo-DHF will test the hypothesis that aldosterone receptor blockade by spironolactone will improve exercise capacity and diastolic function in patients with DHF.
METHODS: Aldo-DHF is a randomized, placebo-controlled, double-blinded, two-armed, multicentre, parallel group study. Four hundred and twenty patients with DHF will be randomly assigned to receive spironolactone 25 mg per day or placebo. The main inclusion criteria are: age > or = 50 years, New York Heart Association II/III, preserved left ventricular ejection fraction (> or =50%), and echocardiographic evidence of diastolic dysfunction. The two primary endpoints are changes in exercise capacity (peak VO(2), spiroergometry) and in diastolic function (E/é, echocardiography) after 12 months. Secondary endpoints include effects of spironolactone on additional parameters of exercise performance and diastolic as well as systolic function, neurohumoral activation, and quality of life. Morbidity and mortality as well as safety aspects will also be assessed.
CONCLUSION: Aldo-DHF is the first large-scale clinical trial to evaluate the effects of aldosterone receptor blockade on exercise capacity and diastolic function in patients with DHF. Aldo-DHF will provide important information about the clinical course of this condition and may have significant impact on treatment strategies and future trials in these patients.
Authors:
Frank Edelmann; Albrecht G Schmidt; Götz Gelbrich; Lutz Binder; Christoph Herrmann-Lingen; Martin Halle; Gerd Hasenfuss; Rolf Wachter; Burkert Pieske
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2010-06-10
Journal Detail:
Title:  European journal of heart failure : journal of the Working Group on Heart Failure of the European Society of Cardiology     Volume:  12     ISSN:  1879-0844     ISO Abbreviation:  Eur. J. Heart Fail.     Publication Date:  2010 Aug 
Date Detail:
Created Date:  2010-08-02     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100887595     Medline TA:  Eur J Heart Fail     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  874-82     Citation Subset:  IM    
Affiliation:
Department of Cardiology and Pneumology, University of Göttingen, Robert-Koch-Str. 40, D-37075 Göttingen, Germany.
Data Bank Information
Bank Name/Acc. No.:
ISRCTN/ISRCTN94726526
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