Heart FailureHFPEFNCT02068040
Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)
A study testing CocoaVia in people with Heart Failure, run by University of California, San Diego at 1 site in United States.
Trial summary
The major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the 1. structural and functional features of skeletal muscle (SkM) 2. exercise capacity (as assessed by VO2 max) 3. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- CocoaVia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medically Diagnosed Heart Failure with Ejection Fraction of >55%
- BMI 27-32
- No Significant HbA1C fluctuations in past 6 months
Who cannot join
- Smoking or quit smoking less than 1 year prior to enrollment
- Substance Abuse
- Taking Coudmadin or Pradaxa
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
The major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the
- structural and functional features of skeletal muscle (SkM)
- exercise capacity (as assessed by VO2 max)
- parameters of diastolic heart function (as assessed by echocardiography)
We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead to a significant improvement in exercise capacity and diastolic function.
Read the detailed description
Patient Inclusion/Exclusion Criteria:
- New York Heart Association Class II/III HF with preserved ejection fraction (EF) of >50%.
- Nonsmokers
- Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug eluting stent will not be excluded.
- Ages between 40-65. We will exclude any women of child bearing potential
- Conditions
- Heart Failure
- Being tested
- CocoaVia
- Keywords
- with preserved ejection fraction of >55%
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocoaViaDietary supplement
Also called Epicatechin consumption
CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol
| Study group | Role | What they receive |
|---|---|---|
| CocoaVia capsules | Experimental | From baseline to 3 months, patients will consume 2 capsules containing pure epicatechin Receives: Dietary Supplement: CocoaVia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in exercise capacity
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max
Measured: Baseline and 3 months
Change from baseline in skeletal muscle metabolism
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
Measured: Baseline and 3 months
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pam Taub, MD, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068040
- Sponsor's protocol ID
- UCSD IRB 130398
- Acronym
- HFPEF
- Status last verified
- Jun 2015
- First submitted
- 18 Feb 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
Publications
Taub PR, Ramirez-Sanchez I, Ciaraldi TP, Perkins G, Murphy AN, Naviaux R, Hogan M, Maisel AS, Henry RR, Ceballos G, Villarreal F. Alterations in skeletal muscle indicators of mitochondrial structure and biogenesis in patients with type 2 diabetes and heart failure: effects of epicatechin rich cocoa. Clin Transl Sci. 2012 Feb;5(1):43-7. doi: 10.1111/j.1752-8062.2011.00357.x. Epub 2011 Nov 7.
PubMed 22376256
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)
- ClinicalTrials.gov ID
- NCT02068040
- Acronym / sponsor ID
- HFPEF / UCSD IRB 130398
- Conditions
- Heart Failure
- Keywords
- with preserved ejection fraction of >55%
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major goal of this proposal is to characterize the ability of epicatechin which a component of dark chocolate to improve the
- structural and functional features of skeletal muscle (SkM)
- exercise capacity (as assessed by VO2 max)
- parameters of diastolic heart function (as assessed by echocardiography)
We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead to a significant improvement in exercise capacity and diastolic function.
Detailed description
Patient Inclusion/Exclusion Criteria:
- New York Heart Association Class II/III HF with preserved ejection fraction (EF) of >50%.
- Nonsmokers
- Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug eluting stent will not be excluded.
- Ages between 40-65. We will exclude any women of child bearing potential
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CocoaVia capsules | Experimental | Dietary Supplement: CocoaViaFrom baseline to 3 months, patients will consume 2 capsules containing pure epicatechin |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medically Diagnosed Heart Failure with Ejection Fraction of >55%
- BMI 27-32
- No Significant HbA1C fluctuations in past 6 months
Key exclusion criteria (3 listed)
- Smoking or quit smoking less than 1 year prior to enrollment
- Substance Abuse
- Taking Coudmadin or Pradaxa
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 |
|---|---|---|
| CocoaViaAlso: Epicatechin consumptionCocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol | Dietary supplement | CocoaVia capsules |
Primary outcome
Change from baseline in exercise capacity
Time frame: Baseline and 3 months
Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max
Change from baseline in skeletal muscle metabolism
Time frame: Baseline and 3 months
The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine
Time frame: Baseline and 3 months
Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Background: PubMed 22376256Taub PR, Ramirez-Sanchez I, Ciaraldi TP, Perkins G, Murphy AN, Naviaux R, Hogan M, Maisel AS, Henry RR, Ceballos G, Villarreal F. Alterations in skeletal muscle indicators of mitochondrial structure and biogenesis in patients with type 2 diabetes and heart failure: effects of epicatechin rich cocoa. Clin Transl Sci. 2012 Feb;5(1):43-7. doi: 10.1111/j.1752-8062.2011.00357.x. Epub 2011 Nov 7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CocoaVia in people with Heart Failure, run by University of California, San Diego at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in exercise capacity (time frame: Baseline and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02068040, which also lists 1 linked publication.
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 3 Jun 2015.