The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study (ImPrOVE)
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|ClinicalTrials.gov Identifier: NCT01102140|
Recruitment Status : Terminated (Investigator left University of Michigan)
First Posted : April 13, 2010
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Cardiomyopathy Heart Failure||Drug: POMx, pomegranate polyphenol extract Drug: Sugar Pill||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||The participant will either receive POMx or matching placebo (sugar pill)|
|Official Title:||The Impact of Pomegranate (Punica Granatum) Polyphenol Extract on Oxidative Stress, Ventricular Remodeling and Endothelial Function in Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||May 31, 2013|
|Actual Study Completion Date :||May 31, 2013|
Active Comparator: POMx
15 subjects will received 1000 mg of oral POMx for 12 weeks.
Drug: POMx, pomegranate polyphenol extract
1000 mg orally once daily.
Placebo Comparator: Control- sugar Pill
15 subjects will receive a matching sugar pill for 12 weeks.
Drug: Sugar Pill
Matching sugar pill
- Thiobarbituric Reactive Substances (TBARS) [ Time Frame: baseline and after 12 weeks ]This is a serum marker of oxidative stress.
- F-8 Isoprostanes [ Time Frame: Baseline and 12 weeks ]This is a serum marker of oxidative stress.
- Procollagen Types I (PINP) and III (PIIINP) [ Time Frame: baseline and 12 weeks ]This is a serum marker of collagen turnover (fibrosis/scar formation).
- Asymmetric Dimethylarginine (ADMA) [ Time Frame: baseline and 12 weeks ]ADMA is a serum enzyme involved in metabolism of endothelium derived nitric oxide (NO). NO's has an important role in maintaining endothelial homeostasis. Elevated ADMA levels suggest impaired endothelial function.
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102140
|United States, Michigan|
|University of Michigan Health Systems|
|Ann Arbor, Michigan, United States, 48109|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Jennifer C Matthews, MD, MS||Univeristy of Michigan Health System|
|Study Chair:||Bertram Pitt, MD||University of Michigan|
|Responsible Party:||Jennifer Cowger , MD, MS, Assistant Professor, study PI, University of Michigan|
|Other Study ID Numbers:||
|First Posted:||April 13, 2010 Key Record Dates|
|Results First Posted:||July 14, 2017|
|Last Update Posted:||July 14, 2017|
|Last Verified:||June 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|