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

Primary Purpose

Cardiomyopathy, Heart Failure

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

POMx, pomegranate polyphenol extract

Sugar Pill

About this trial

This is an interventional treatment trial for Cardiomyopathy focused on measuring Cardiomyopathy, Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Michigan Health Systems
University of Michigan Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

POMx

Control- sugar Pill

Arm Description

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

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

Outcomes

Primary Outcome Measures

Thiobarbituric Reactive Substances (TBARS)

This is a serum marker of oxidative stress.

Secondary Outcome Measures

F-8 Isoprostanes

This is a serum marker of oxidative stress.

Procollagen Types I (PINP) and III (PIIINP)

This is a serum marker of collagen turnover (fibrosis/scar formation).

Asymmetric Dimethylarginine (ADMA)

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.

Full Information

NCT ID

NCT01102140

First Posted

April 12, 2010

Last Updated

June 13, 2017

Sponsor

Jennifer Cowger , MD, MS

Collaborators

POM Wonderful LLC

1. Study Identification

Unique Protocol Identification Number

NCT01102140

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Investigator left University of Michigan

Study Start Date

July 2010 (undefined)

Primary Completion Date

May 31, 2013 (Actual)

Study Completion Date

May 31, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jennifer Cowger , MD, MS

Collaborators

POM Wonderful LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiomyopathy, Heart Failure

Keywords

Cardiomyopathy, Heart Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

The participant will either receive POMx or matching placebo (sugar pill)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

POMx

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control- sugar Pill

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

POMx, pomegranate polyphenol extract

Intervention Description

1000 mg orally once daily.

Intervention Type

Drug

Intervention Name(s)

Sugar Pill

Intervention Description

Matching sugar pill

Primary Outcome Measure Information:

Title

Thiobarbituric Reactive Substances (TBARS)

Description

This is a serum marker of oxidative stress.

Time Frame

baseline and after 12 weeks

Secondary Outcome Measure Information:

Title

F-8 Isoprostanes

Description

This is a serum marker of oxidative stress.

Time Frame

Baseline and 12 weeks

Title

Procollagen Types I (PINP) and III (PIIINP)

Description

This is a serum marker of collagen turnover (fibrosis/scar formation).

Time Frame

baseline and 12 weeks

Title

Asymmetric Dimethylarginine (ADMA)

Description

Time Frame

baseline and 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer C Matthews, MD, MS

Organizational Affiliation

Univeristy of Michigan Health System

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bertram Pitt, MD

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

Facility Name

University of Michigan Health Systems

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

University of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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