Aldosterone Blockade in Heart Failure

• Status: Completed
• Trial end date: 2010-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Heart failure causes significant morbidity and mortality and is the most rapidly increasing cardiovascular diagnosis in North America overall prevalence is estimated at 0.4% to 2.4%. Recently, heart failure with a preserved ejection fraction (HFNEF) was found in up to 50% of patients with symptomatic heart failure. Many studies have demonstrated that HFNEF has a poor prognosis with a mortality rate of up to 8% per year and a 50% chance of needing to be admitted to hospital in the next year. There are no proven therapies for this type of heart failure.

Aldosterone blockers (these drugs block a hormone that is elevated in patients with heart failure) are used in other types of heart failure. Our goal is to see if this type of drug improves the function of the heart by looking at the thickness of the heart muscle using MRI. Also we will measure the amount of tissue formation and breakdown in the heart. The trial will be done using both the drug and a placebo so that we can see what effects are due to the drug.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Justin Ezekowitz; University of Alberta
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

1. HF by Framingham criteria

2. At least one admission to hospital for HF within the last 180 days

3. New York Heart Association Class II thru IV

4. Echocardiographic criteria:At least moderate diastolic dysfunction, Ejection fraction >45%

Exclusion Criteria:

1. Creatinine clearance <40 mls/min/1.73m2

2. Potassium >5.0 mmol/L

3. Recent acute coronary syndrome in the prior 4 weeks

4. Planned revascularization, defibrillator or pacemaker in next 4 months

5. Known previous intolerance to aldosterone antagonist