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Edelmann, F; Schmidt, AG; Gelbrich, G; Binder, L; Herrmann-Lingen, C; Halle, M; Hasenfuss, G; Wachter, R; Pieske, B.
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):874-882
Doi: 10.1093/eurjhf/hfq087
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- Führende Autor*innen der Med Uni Graz
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Pieske Burkert Mathias
- Co-Autor*innen der Med Uni Graz
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Schmidt Albrecht
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- 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 >= 50 years, New York Heart Association 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. 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.
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Aldosterone -
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Diastole - drug effects
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Disease Progression -
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Diuretics - therapeutic use
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Double-Blind Method -
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Exercise Tolerance - drug effects
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Health Status Indicators -
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Heart Failure, Diastolic - drug therapy Heart Failure, Diastolic - physiopathology Heart Failure, Diastolic - ultrasonography
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Humans -
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Mineralocorticoid Receptor Antagonists - therapeutic use
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Oxygen Consumption -
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Placebos -
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Questionnaires -
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Research Design -
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Spironolactone - therapeutic use
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Stroke Volume -
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Ventricular Function, Left -
- Find related publications in this database (Keywords)
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Aldosterone receptor blockade
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Spironolactone
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Diastolic heart failure
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Echocardiography
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Exercise therapy
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Therapy