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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Michigan
Sponsor:
Collaborator:
POM Wonderful LLC
Information provided by (Responsible Party):
Jennifer Cowger , MD, MS, University of Michigan
ClinicalTrials.gov Identifier:
NCT01102140
First received: April 12, 2010
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Cardiomyopathy
Heart Failure
Drug: POMx, pomegranate polyphenol extract
Drug: Sugar Pill
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • thiobarbituric reactive substances (TBARS) [ Time Frame: baseline and after 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • F-8 isoprostanes [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
  • procollagen types I (PINP) and III (PIIINP) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • asymmetric dimethylarginine (ADMA) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01102140

Contacts
Contact: Joanna Wells 734 232-6383 joannamw@med.umich.edu
Contact: Jennifer C Matthews, MD, MS 734 936-5265 jennmatt@umich.edu

Locations
United States, Michigan
University of Michigan Health System Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Jennifer A Cowger, MD, MS         
Sub-Investigator: Bertram Pitt, MD         
University of Michigan Health Systems Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Joanna Wells    734-232-6383    joannamw@med.umich.edu   
Contact: Jennifer A Cowger, MD, MS    734 232 4154    jennmatt@med.umich.edu   
Sponsors and Collaborators
Jennifer Cowger , MD, MS
POM Wonderful LLC
Investigators
Principal Investigator: Jennifer C Matthews, MD, MS Univeristy of Michigan Health System
Study Chair: Bertram Pitt, MD University of Michigan
  More Information

No publications provided

Responsible Party: Jennifer Cowger , MD, MS, Assistant Professor, study PI, University of Michigan
ClinicalTrials.gov Identifier: NCT01102140     History of Changes
Other Study ID Numbers: IMPROVEHF
Study First Received: April 12, 2010
Last Updated: December 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
Cardiomyopathy
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Ventricular Remodeling
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 31, 2014