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AP Aldosterone Receptor Blockade in Diastolic Heart Failure

Background

In diastolic heart failure the increased tissue rigidity impairs the filling of the heart chambers, but the ejection fraction during systole is typically normal. Risk factors for diastolic heart failure include arterial hypertension, diabetes mellitus and sleep apnea. However, a number of other diseases can also lead to diastolic heart failure. Unfortunately, the diagnosis of diastolic heart failure has been possible up to now only with complex cardiac catheter techniques. Very recently, however, the use of state-of-the-art imaging procedures (e.g. Doppler echocardiography) and new laboratory markers (BNP, Nt-pro BNP) facilitate definitive diagnosis with non-invasive methods. The use of these new diagnostic techniques has shown that in Germany up to 50% of patients with symptoms of heart failure suffer from isolated diastolic heart failure. However, up to now there has been hardly any data available from prospective, placebo-controlled treatment studies with regard to the treatment of diastolic heart failure.

Objective

Thus, the objective of the ALDO-DHF study is to investigate the significance of an aldosterone receptor blockade with spironolactone in the course of diastolic heart failure. For this purpose, a total of 420 patients are to be treated in a placebo-controlled study over a follow-up observation period of one year. The primary end points are physical performance (quantified by spiroergometry) and Doppler-echocardiographic parameters for diastolic dysfunction. The secondary end points include quality of life and morbidity. The ALDO-DHF study is financed as an industry-independent clinical study as part of the „Clinical Studies“ program of the German Federal Ministry for Education and Research (Bundesministerium für Bildung und Forschung (BMBF)). The study uses the infrastructure of the Heart Failure Competence Network, thus enhancing its effectiveness. It was therefore integrated in the Heart Failure Competence Network as an associated subproject.

Main result

The ALDO-DHF trial showed favourable effects n well-established echocardiographic surrogates of clinical outcome (E/e´) but did not affect exercise performance measured by ergospirometry (peak VO2 max). Important information on changes in quality of life are currently analysed.

Publications

  • 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;12:874-82.
  • Edelmann F et al. Serum aldosterone and its relationship to left ventricular structure and geometry in patients with preserved left ventricular ejection fraction. Eur Heart J. 2012;33:203-12.

Perspective

The ALDO-DHF trial will expand the hitherto limited treatment options for and the corresponding knowledge regarding the underlying pathophysiologic pathways in patients with diastolic heart failure. The database is open for collaborative research questions from academic and industrial partners.

Contact

Dr. Frank Edelmann
Universitätsmedizin Göttingen
Abteilung Kardiologie und Pneumologie
Phone: +49 (0)551 399258
E-Mail: ed.negnitteog-inu.demnull@nnamledef

Prof. Dr. Burkert Pieske
Medizinische Universität Graz
Klinische Abteilung für Kardiologie
Phone: +43 (0)316 38512544
E-Mail: ta.zarginudemnull@ekseip.trekrub