Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function

Completed · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive

In brief

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.

Key facts

Study ID: NCT00094302
Run by: Carelon Research
People needed: 3445
Starts: 2006-08-01
Expected to finish: 2013-06-01
Last updated by the study team: 2015-03-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Cardiovascular Consultants, Ltd. — Glendale, Arizona, United States
Carl T. Hayden VA Medical Center — Phoenix, Arizona, United States
Central Arkansas Veterans Healthcare System — Little Rock, Arkansas, United States
Heart Clinic Arkansas — Little Rock, Arkansas, United States
Cynthia Thaik — Burbank, California, United States
Fresno VA Medical Center — Fresno, California, United States
Clinica Medica San Miguel — Los Angeles, California, United States
CAPRI — Los Angeles, California, United States
VA Medical Center West Los Angeles — Los Angeles, California, United States
Mehrdad Kevin Ariani, MD, Inc. — Northridge, California, United States
UC Davis Medical Center — Sacremento, California, United States
Central Coast Cardiology — Salinas, California, United States
Naval Medical Center San Diego — San Diego, California, United States
Olive View - UCLA Medial Center — Sylmar, California, United States
University of Colorado Health Sciences Center — Aurora, Colorado, United States
Cardio-Vascular Institute — Greeley, Colorado, United States
University of Connecticut Health Center — Farmington, Connecticut, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
Howard University Hospital — Washington D.C., District of Columbia, United States
Washington DC VA Hospital — Washington D.C., District of Columbia, United States
Daytona Heart Group — Daytona Beach, Florida, United States
M & O Clinical Research, LLC — Fort Lauderdale, Florida, United States
Florida Heart Center — Ft. Pierce, Florida, United States
University of Florida — Gainesville, Florida, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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