CardiomyopathyPhase 2ImPrOVENCT01102140
The Impact of Pomegranate Extract on Chronic Cardiomyopathy Complicated by Renal Insufficiency (ImPrOVE): a Pilot Study
A Phase 2 study testing POMx, pomegranate polyphenol extract and Sugar Pill in people with Cardiomyopathy and Heart Failure, run by Jennifer Cowger , MD, MS at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiomyopathy, Heart Failure
- What is being tested?
- POMx, pomegranate polyphenol extract and Sugar Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to 31 May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Health Systems
Ann Arbor, Michigan, 48109
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
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
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.
Read the 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
- Being tested
- POMx, pomegranate polyphenol extract, Sugar Pill
- Keywords
- Cardiomyopathy, Heart Failure
- Medical subject headings
- Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POMx, pomegranate polyphenol extractDrug
1000 mg orally once daily.
Sugar PillDrug
Matching sugar pill
| Study group | Role | What they receive |
|---|---|---|
| POMx | Active comparator | 15 subjects will received 1000 mg of oral POMx for 12 weeks. Receives: Drug: POMx, pomegranate polyphenol extract |
| Control- sugar Pill | Placebo comparator | 15 subjects will receive a matching sugar pill for 12 weeks. Receives: Drug: Sugar Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thiobarbituric Reactive Substances (TBARS)
This is a serum marker of oxidative stress.
Measured: baseline and after 12 weeks
Secondary outcomes (3)
F-8 Isoprostanes
This is a serum marker of oxidative stress.
Measured: Baseline and 12 weeks
Procollagen Types I (PINP) and III (PIIINP)
This is a serum marker of collagen turnover (fibrosis/scar formation).
Measured: baseline and 12 weeks
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.
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startJul 2010
- Primary completion31 May 2013
- Study completion31 May 2013
Why it stopped: Investigator left University of Michigan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennifer Cowger , MD, MS
- Sponsor type
- University, hospital or other
- Collaborators
- POM Wonderful LLC
- Responsible party
- Sponsor-investigator, Jennifer Cowger , MD, MS, University of Michigan
- Investigators
- Jennifer C Matthews, MD, MS, Principal investigator, Univeristy of Michigan Health SystemBertram Pitt, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102140
- Sponsor's protocol ID
- IMPROVEHF
- Acronym
- ImPrOVE
- Status last verified
- Jun 2017
- First submitted
- 12 Apr 2010
- Last updated
- 14 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01102140
- Acronym / sponsor ID
- ImPrOVE / IMPROVEHF
- Conditions
- Cardiomyopathy, Heart Failure
- Keywords
- Cardiomyopathy, Heart Failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left University of Michigan
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Jennifer Cowger , MD, MSUniversity, hospital or other
- Collaborators
- POM Wonderful LLC
- Study start
- Jul 2010
- Primary completion
- 31 May 2013 (actual)
- Study completion
- 31 May 2013 (actual)
- First posted
- 13 Apr 2010 (estimated)
- Results
- Posted 14 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POMx | Active comparator | Drug: POMx, pomegranate polyphenol extract15 subjects will received 1000 mg of oral POMx for 12 weeks. |
| Control- sugar Pill | Placebo comparator | Drug: Sugar Pill15 subjects will receive a matching sugar pill for 12 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POMx, pomegranate polyphenol extract1000 mg orally once daily. | Drug | POMx |
| Sugar PillMatching sugar pill | Drug | Control- sugar Pill |
Primary outcome
Thiobarbituric Reactive Substances (TBARS)
Time frame: baseline and after 12 weeks
This is a serum marker of oxidative stress.
3 secondary outcomes
F-8 Isoprostanes
Time frame: Baseline and 12 weeks
Procollagen Types I (PINP) and III (PIIINP)
Time frame: baseline and 12 weeks
Asymmetric Dimethylarginine (ADMA)
Time frame: baseline and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer C Matthews, MD, MS principal investigator
Univeristy of Michigan Health System
Bertram Pitt, MD study chair
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing POMx, pomegranate polyphenol extract and Sugar Pill in people with Cardiomyopathy and Heart Failure, run by Jennifer Cowger , MD, MS at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thiobarbituric Reactive Substances (TBARS) (time frame: baseline and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.