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 pa (2024)

Abstract

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.MethodsAldo-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 ≥ 50 years, New York Heart Association II/III, preserved left ventricular ejection fraction (≥50), and echocardiographic evidence of diastolic dysfunction. The two primary endpoints are changes in exercise capacity (peak VO2, 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.ConclusionAldo-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.

Original languageEnglish
Pages (from-to)874-882
Number of pages9
JournalEuropean Journal of Heart Failure
Volume12
Issue number8
DOIs
StatePublished - Aug 2010

Keywords

  • Aldosterone receptor blockade
  • Diastolic heart failure
  • Echocardiography
  • Exercise, therapy
  • Spironolactone
  • Therapy

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Edelmann, F., Schmidt, A. G., Gelbrich, G., Binder, L., Herrmann-Lingen, C., Halle, M., Hasenfuss, G., Wachter, R., & Pieske, B. (2010). 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). European Journal of Heart Failure, 12(8), 874-882. https://doi.org/10.1093/eurjhf/hfq087

Edelmann, Frank ; Schmidt, Albrecht G. ; Gelbrich, Götz et al. / 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). In: European Journal of Heart Failure. 2010 ; Vol. 12, No. 8. pp. 874-882.

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title = "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)",

abstract = "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.MethodsAldo-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 ≥ 50 years, New York Heart Association II/III, preserved left ventricular ejection fraction (≥50), and echocardiographic evidence of diastolic dysfunction. The two primary endpoints are changes in exercise capacity (peak VO2, spiroergometry) and in diastolic function (E/{\'e}, 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.ConclusionAldo-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.",

keywords = "Aldosterone receptor blockade, Diastolic heart failure, Echocardiography, Exercise, therapy, Spironolactone, Therapy",

author = "Frank Edelmann and Schmidt, {Albrecht G.} and G{\"o}tz Gelbrich and Lutz Binder and Christoph Herrmann-Lingen and Martin Halle and Gerd Hasenfuss and Rolf Wachter and Burkert Pieske",

year = "2010",

month = aug,

doi = "10.1093/eurjhf/hfq087",

language = "English",

volume = "12",

pages = "874--882",

journal = "European Journal of Heart Failure",

issn = "1388-9842",

publisher = "Wiley-Blackwell",

number = "8",

}

Edelmann, F, Schmidt, AG, Gelbrich, G, Binder, L, Herrmann-Lingen, C, Halle, M, Hasenfuss, G, Wachter, R & Pieske, B 2010, '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)', European Journal of Heart Failure, vol. 12, no. 8, pp. 874-882. https://doi.org/10.1093/eurjhf/hfq087

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). / Edelmann, Frank; Schmidt, Albrecht G.; Gelbrich, Götz et al.
In: European Journal of Heart Failure, Vol. 12, No. 8, 08.2010, p. 874-882.

Research output: Contribution to journalArticlepeer-review

TY - JOUR

T1 - Rationale and design of the 'aldosterone receptor blockade in diastolic heart failure' trial

T2 - 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)

AU - Edelmann, Frank

AU - Schmidt, Albrecht G.

AU - Gelbrich, Götz

AU - Binder, Lutz

AU - Herrmann-Lingen, Christoph

AU - Halle, Martin

AU - Hasenfuss, Gerd

AU - Wachter, Rolf

AU - Pieske, Burkert

PY - 2010/8

Y1 - 2010/8

N2 - 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.MethodsAldo-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 ≥ 50 years, New York Heart Association II/III, preserved left ventricular ejection fraction (≥50), and echocardiographic evidence of diastolic dysfunction. The two primary endpoints are changes in exercise capacity (peak VO2, 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.ConclusionAldo-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.

AB - 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.MethodsAldo-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 ≥ 50 years, New York Heart Association II/III, preserved left ventricular ejection fraction (≥50), and echocardiographic evidence of diastolic dysfunction. The two primary endpoints are changes in exercise capacity (peak VO2, 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.ConclusionAldo-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.

KW - Aldosterone receptor blockade

KW - Diastolic heart failure

KW - Echocardiography

KW - Exercise, therapy

KW - Spironolactone

KW - Therapy

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U2 - 10.1093/eurjhf/hfq087

DO - 10.1093/eurjhf/hfq087

M3 - Article

C2 - 20538867

AN - SCOPUS:77955444052

SN - 1388-9842

VL - 12

SP - 874

EP - 882

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

IS - 8

ER -

Edelmann F, Schmidt AG, Gelbrich G, Binder L, Herrmann-Lingen C, Halle M et al. 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). European Journal of Heart Failure. 2010 Aug;12(8):874-882. doi: 10.1093/eurjhf/hfq087

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 pa (2024)
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