The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study

• Status: Terminated
• Trial end date: 2013-05-31
• Target enrollment: 0
• Participant gender: All

Summary

This blinded, controlled study will examine the impact of pomegranate polyphenol extract (POMx, from Pom Wonderful, LLC), 1000mg on cardiomyopathy in subjects with chronic renal insufficiency.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jennifer Cowger , MD, MS
• Collaborator: POM Wonderful LLC

Criteria

Inclusion Criteria:

• Adult subjects (≥21 years of age) with cardiomyopathy (ejection fraction ≤40%) of at least 1 year duration and CRI (GFR <60 cc/hr for at least 3 months) will be eligible for enrollment.

• Subjects must have New York Heart Association (NYHA) functional class I-III symptoms and be on stable doses of HF evidence-based therapies (β-blocker, ACE inhibitor or ARBs, aldosterone inhibitor [if appropriate]) for at least 3 months or have a documented contraindication or intolerance to such therapy

Exclusion Criteria:

• Subjects admitted to a hospital for acute myocardial infarction (defined as positive troponins) or HF exacerbation within the last 6 months will not be eligible for enrollment.

• Subjects on warfarin or rosuvastatin will also be excluded.

• Other exclusion criteria are as follows:

• HF that is deemed to be congenital or infiltrative in etiology

• the presence of a life-threatening illness with a projected survival ≤6 months; ongoing infection

• pregnancy

• inability to follow-up

• end-stage renal disease requiring dialysis

• renal transplant listing

• recent (within last 6 months) POMx use or intake >8 ounces daily of pomegranate juice

• known hypersensitivity to any fruit in the Punicaceae family

• connective tissue or collagen vascular disease