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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
Sponsor:
Collaborator:
POM Wonderful LLC
Information provided by (Responsible Party):
Jennifer Cowger , MD, MS, University of Michigan

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cardiomyopathy Heart Failure Drug: POMx, pomegranate polyphenol extract Drug: Sugar Pill Phase 2

Detailed Description:
Heart failure (HF) is a disease of great prevalence in the U.S. with an associated high morbidity and mortality. In individuals with concomitant chronic renal insufficiency (CRI), outcomes are even worse due to pharmaceutical under treatment and higher baseline levels of oxidative stress. Reactive oxygen species (ROS) are generated during mechanoenergetic uncoupling and can cause myocardial protein, lipid, and DNA damage, leading to the development of HF. One means of preventing the progression of HF may be through ROS reduction or an improvement in systemic or local oxidative stress handling. In this randomized, single blind placebo-controlled pilot study, we hypothesize that 12 weeks of treatment with oral pomegranate extract (POMx) will lead to a reduction in oxidative stress (as assessed by measuring thiobarbituric acid-reactive substances, F8-isoprostanes, and glutathione) in subjects (n=30) with cardiomyopathy (LVEF ≤40%) and CRI (GFR <60 ml/hr). Secondary aims include assessing the impact of POMx on myocardial remodeling and endothelial dysfunction by measuring serum collagen levels and asymmetric dimethylarginine, respectively. Findings from this study will serve as pilot data for a larger randomized trial of longer term POMx therapy in subjects with cardiomyopathy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The participant will either receive POMx or matching placebo (sugar pill)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Thiobarbituric Reactive Substances (TBARS) [ Time Frame: baseline and after 12 weeks ]
    This is a serum marker of oxidative stress.


Secondary Outcome Measures :
  1. F-8 Isoprostanes [ Time Frame: Baseline and 12 weeks ]
    This is a serum marker of oxidative stress.

  2. Procollagen Types I (PINP) and III (PIIINP) [ Time Frame: baseline and 12 weeks ]
    This is a serum marker of collagen turnover (fibrosis/scar formation).

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Jennifer Cowger , MD, MS
POM Wonderful LLC
Investigators
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Principal Investigator: Jennifer C Matthews, MD, MS Univeristy of Michigan Health System
Study Chair: Bertram Pitt, MD University of Michigan
More Information
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Responsible Party: Jennifer Cowger , MD, MS, Assistant Professor, study PI, University of Michigan
ClinicalTrials.gov Identifier: NCT01102140    
Other Study ID Numbers: IMPROVEHF
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

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Studies a U.S. FDA-regulated Drug Product: No
Keywords provided by Jennifer Cowger , MD, MS, University of Michigan:
Cardiomyopathy
Heart Failure
Additional relevant MeSH terms:
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Renal Insufficiency
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
 Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases