Tags

Type your tag names separated by a space and hit enter

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).
Eur J Heart Fail. 2010 Aug; 12(8):874-82.EJ

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.

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+Show Affiliations

Department of Cardiology and Pneumology, University of Göttingen, Robert-Koch-Str. 40, D-37075 Göttingen, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20538867

Citation

Edelmann, Frank, 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, vol. 12, no. 8, 2010, pp. 874-82.
Edelmann F, Schmidt AG, Gelbrich G, 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). Eur J Heart Fail. 2010;12(8):874-82.
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), 874-82. https://doi.org/10.1093/eurjhf/hfq087
Edelmann F, 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). Eur J Heart Fail. 2010;12(8):874-82. PubMed PMID: 20538867.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). 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, Y1 - 2010/06/10/ PY - 2010/6/12/entrez PY - 2010/6/12/pubmed PY - 2011/6/22/medline SP - 874 EP - 82 JF - European journal of heart failure JO - Eur. J. Heart Fail. VL - 12 IS - 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. 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. SN - 1879-0844 UR - https://www.unboundmedicine.com/medline/citation/20538867/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__ L2 - https://doi.org/10.1093/eurjhf/hfq087 DB - PRIME DP - Unbound Medicine ER -