The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Cardiomyopathy, Heart Failure
In brief
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.
Key facts
- Study ID
- NCT01102140
- Run by
- Jennifer Cowger , MD, MS
- People needed
- 20
- Starts
- 2010-07-01
- Expected to finish
- 2013-05-31
- Last updated by the study team
- 2017-07-14
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Michigan Health Systems — Ann Arbor, Michigan, United States
- University of Michigan Health System — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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