500 Boylston Street, Boston, MA 02116 617-419-4700
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The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy
in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure
hospitalization in patients who have heart failure with preserved systolic function.
Ages:50 and older
INCLUSION CRITERIA: - Heart failure as defined by at least one of symptom (paroxysmal nocturnal dyspnea; orthopnea; or dyspnea on mild or moderate exertion) at the time of screening and at least one sign (any rales post cough; jugular venous pressure(JVP) greater than or equal to 10cm of water(H2O); lower extremity edema; or chest x-ray demonstrating pleural effusion, pulmonary congestion, or cardiomegaly) within 12 months prior to study entry: - left ventricular ejection fraction greater than or equal to 45% (per local reading); the ejection fraction must have been obtained within 6 months prior to randomization and after any MI or other event that would affect ejection fraction - Controlled systolic blood pressure(BP), defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP - Serum potassium less than 5.0 mmol/L prior to randomization - At least one hospital admission for which heart failure was a major component of the hospitalization some time within the 12 months prior to study entry OR brain natriuretic peptide (BNP) greater than or equal to 100pg/ml or N-terminal pro-BNP greater than or equal to 360pg/ml within the 60 days prior to study entry - Women of child-bearing potential must have a negative serum/urine pregnancy test within 72 hours prior to randomization, must not be lactating, and must agree to use an effective method of contraception during the entire course of study participation - Willing to comply with scheduled visits - Informed consent form signed by the subject prior to participation in the trial EXCLUSION CRITERIA: - Severe systemic illness with an expected life expectancy of less than 3 years - Chronic pulmonary disease requiring home O2, oral steroid therapy, or hospitalization for exacerbation within 12 months of study entry, or significant chronic pulmonary disease in the opinion of the investigator - Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction - Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant, or any valvular disease expected to lead to surgery during the trial - Atrial fibrillation with a resting heart rate greater than 90 bpm - MI in the past 90 days - Coronary artery bypass graft surgery in the past 90 days - Percutaneous coronary intervention in the past 30 days - Heart transplant recipient - Currently implanted left ventricular assist device - Stroke in past 90 days - Systolic BP (SBP) greater than 160 mm Hg - Known orthostatic hypotension - Gastrointestinal disorder that could interfere with study drug absorption - Use of any aldosterone antagonist or potassium sparing medication in the last 14 days or any known condition that would require the use of an aldosterone antagonist during study participation; - Known intolerance to aldosterone antagonists - Current lithium use - Current participation (including prior 30 days) in any other therapeutic trial - Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol - History of hyperkalemia (serum potassium greater than or equal to 5.5mmol/L) in the past 6 months or serum potassium greater than or equal to 5.0mmol/L within the past 2 weeks - Severe renal dysfunction, defined as an estimated glomerular filtration rate(GFR) less than 30ml/min. Participants with serum creatinine greater than or equal to 2.5mg/dl are also excluded even if their GFR is greater than or equal to 30ml/min - Known chronic hepatic disease, defined as aspartate aminotransferase(AST) and alanine aminotransferase(ALT) levels greater than 3.0 times the upper limit of normal as read at the local lab.
Sponsor: New England Research Institutes
Phase: Phase 3
Trial ID: NCT00094302
Not Accepting Healthy Volunteers