Clinical TrialResults of the Randomized Aldosterone Antagonism in Heart Failure With Preserved Ejection Fraction Trial (RAAM-PEF)
Section snippets
Study Design and Subjects
We performed a single-center, randomized, double blind, placebo-controlled trial to evaluate the benefit of eplerenone in patients with HFpEF (ClinicalTrials.gov number NCT00108251). The study was conducted at the Michael E. DeBakey VA Medical Center, Houston, TX. After a 2-week open label period of eplerenone 25 mg daily to establish tolerability, eligible patients were randomized in a 1:1 ratio to either eplerenone or matching placebo (detailed study design in Fig. 1). Tolerability was
Study Population
The trial profile is shown in Figure 2. Of the 198 patients screened, 150 were excluded, of which 28 patients refused to participate or appeared unable to adhere to the study procedures and 122 met at least 1 exclusion criterion including significant comorbidities (n = 27) such as severe lung disease, nonrevascularizable coronary artery disease or malignancy, serum creatinine > 2.5 mg/dL (n = 30), serum potassium > 5 mEq/L (n = 5), BNP < 100 pg/mL (n = 15), significant valvular heart disease
Discussion
This study is the first double-blind, randomized, placebo controlled trial that examines the effect of eplerenone, an aldosterone antagonist, on exercise capacity in relation to changes in circulating biomarkers of collagen turnover and diastolic function, in patients with established and symptomatic HFpEF. In a population of predominantly elderly male patients with HFpEF treated for 6 months, as compared with placebo, eplerenone did not result in benefit in exercise capacity as measured by the
Conclusions
This study represents the first double-blind, randomized, placebo-controlled trial to examine the benefit of the aldosterone antagonist, eplerenone, on exercise capacity in patients with established and symptomatic HFpEF. As compared to placebo, treatment with eplerenone over 6 months did not confer any benefit on exercise capacity, although it did result in favorable changes in some of the collagen markers and in diastolic function. Whether the changes in collagen turnover and diastolic
Acknowledgments
The authors thank Dr. Mark Dunlap and Dr. Nancy Petersen for their invaluable efforts as members of the DSMB, Ms. Adrienne Chee for her relentless work as study coordinator, and the patients that participated in this research study.
The views expressed in this article are those of the authors and do not necessarily represent those of the Department of Veteran Affairs.
Disclosure
None.
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Supported by a VA Clinical Research Service grant # CLIN-010-03S (to Dr. Deswal).
Clinical Trial Registration information at www.clinicaltrials.gov:NCT00108251.
Conflict of Interest: None.
See page 641 for disclosure information.