NCT01102140

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2013

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

July 14, 2017

Completed
Last Updated

July 14, 2017

Status Verified

June 1, 2017

Enrollment Period

2.9 years

First QC Date

April 12, 2010

Results QC Date

May 18, 2017

Last Update Submit

June 13, 2017

Conditions

CardiomyopathyHeart Failure

Keywords

CardiomyopathyHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Thiobarbituric Reactive Substances (TBARS)

    This is a serum marker of oxidative stress.

    baseline and after 12 weeks

Secondary Outcomes (3)

  • F-8 Isoprostanes

    Baseline and 12 weeks

  • Procollagen Types I (PINP) and III (PIIINP)

    baseline and 12 weeks

  • Asymmetric Dimethylarginine (ADMA)

    baseline and 12 weeks

Study Arms (2)

POMx

ACTIVE COMPARATOR

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

Drug: POMx, pomegranate polyphenol extract

Control- sugar Pill

PLACEBO COMPARATOR

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

Drug: Sugar Pill

Interventions

POMx, pomegranate polyphenol extractDRUG

1000 mg orally once daily.

POMx
Sugar PillDRUG

Matching sugar pill

Control- sugar Pill

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

CardiomyopathiesHeart Failure

Interventions

Sugars

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

Title
Dr. Jennifer Cowger
Organization
University of Michigan
jennifercowger@gmail.com
7345464911

Study Officials

  • Jennifer C Matthews, MD, MS

    Univeristy of Michigan Health System

    PRINCIPAL INVESTIGATOR

  • Bertram Pitt, MD

    University of Michigan

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant will either receive POMx or matching placebo (sugar pill)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor, study PI

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 13, 2010

Study Start

July 1, 2010

Primary Completion

May 31, 2013

Study Completion

May 31, 2013

Last Updated

July 14, 2017

Results First Posted

July 14, 2017

Record last verified: 2017-06

Locations

US(2)