Aldosterone Antagonism in Diastolic Heart Failure

Completed · Phase 4 · Has a placebo group

Conditions studied: Congestive Heart Failure, Diastole

In brief

The primary purpose of this study is to determine whether eplerenone has a beneficial effect on improving exercise ability in patients with diastolic heart failure.

Key facts

Study ID: NCT00108251
Run by: US Department of Veterans Affairs
People needed: 48
Starts: 2004-08-01
Expected to finish: 2007-10-01
Last updated by the study team: 2011-09-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All patients must have DHF as defined by all 3 of the following criteria:
i)Presence of clinical heart failure for greater than or equal to 2 months before the screening visit. At the time of enrollment they should have NYHA functional class II or III heart failure symptoms such as dyspnea, fatigue on exertion, paroxysmal nocturnal dyspnea, and orthopnea.
ii)Left ventricular ejection fraction greater than or equal to 50% (by echo, radionuclide angiography or contrast angiography) within 2 months of screening iii) BNP (brain natriuretic peptide) greater than or equal to 62 pg/ml within 2 months of screening
Patients euvolemic on clinical examination. If patients are not euvolemic, all attempts will be made to achieve a euvolemic state with change in diuretic doses prior to enrollment into the study
Systolic blood pressure less than or equal to 150 mmHg and diastolic blood pressure less than or equal to 95 mmHg for 4 weeks prior to and at the time of enrollment
Able to walk at least 50 m at the time of enrollment
All patients will be required to be on ACE inhibitors or angiotensin receptor blockers for at least 4 weeks prior to enrollment

You may not qualify if…

Patients requiring eplerenone or spironolactone for treatment of other comorbid illnesses, e.g. ascites due to cirrhosis. Also, patients with severe hepatic impairment will not be included.
Contraindication to eplerenone therapy with creatinine > 2.5 mg/dl or serum potassium > 5.0 mEq/L or creatinine clearance < 30 ml/min/1.73 m2 or intolerance to eplerenone or spironolactone in the past
Significant valvular heart disease, pericardial disease or severe chronic lung disease with cor pulmonale, as the cause of symptoms and signs of CHF
Patients with technically inadequate echocardiographic windows or patients with severe mitral annular calcification
Unstable angina or MI within 4 weeks prior to enrollment
Patient with severe peripheral vascular disease and claudication or other physical conditions that will limit the distance walked by them
Pregnant or lactating females
History of alcohol or substance abuse or history of repeated non-compliance with medications
History of cancer within 3 years (other than resected cutaneous basal or squamous cell carcinoma)
Participation in any other drug trial within 30 days prior to enrollment
Inability to provide informed consent
On drugs that are strong inhibitors of CYP3A4 such as ketoconazole, itraconazole, nefazodone, trolandeomycin, clarithromycin, ritonavir, nelfinavir etc.

Where it is running

Michael E DeBakey VA Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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