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

NCT ID: NCT01102140

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-05-31

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.

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.

Conditions

Cardiomyopathy; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

POMx

15 subjects will received 1000 mg of oral POMx for 12 weeks.

Group Type: ACTIVE_COMPARATOR

POMx, pomegranate polyphenol extract

Intervention Type: DRUG

1000 mg orally once daily.

Control- sugar Pill

15 subjects will receive a matching sugar pill for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: DRUG

Matching sugar pill

Interventions

POMx, pomegranate polyphenol extract

1000 mg orally once daily.

Intervention Type: DRUG

Sugar Pill

Matching sugar pill

Intervention Type: DRUG

Eligibility 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.

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

POM Wonderful LLC

INDUSTRY

Sponsor Role: collaborator

Jennifer Cowger , MD, MS

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Cowger , MD, MS

Assistant Professor, study PI

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jennifer C Matthews, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Michigan Health System

Bertram Pitt, MD

Role: STUDY_CHAIR

University of Michigan

Locations

University of Michigan Health Systems

Ann Arbor, Michigan, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

IMPROVEHF

Identifier Type: -

Identifier Source: org_study_id