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

Heart Failure Clinical Trial

— ImPrOVE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01102140
• Other study ID #: IMPROVEHF
• Status: Recruiting
• Phase: Phase 2
• First received: April 12, 2010
• Last updated: December 17, 2012
• Start date: July 2010

Study information

• Verified date: December 2012
• Source: University of Michigan
• Contact: Joanna Wells
• Phone: 734 232-6383
• Email: joannamw[@]med.umich.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 (ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure
• Renal Insufficiency

Intervention

Drug:
• POMx, pomegranate polyphenol extract
1000 mg orally once daily.
• Sugar Pill
Matching sugar pill

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	University of Michigan Health Systems	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Jennifer Cowger , MD, MS	POM Wonderful LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thiobarbituric reactive substances (TBARS)		baseline and after 12 weeks	No
Secondary	F-8 isoprostanes		Baseline and 12 weeks	No
Secondary	procollagen types I (PINP) and III (PIIINP)		baseline and 12 weeks	No
Secondary	asymmetric dimethylarginine (ADMA)		baseline and 12 weeks	No