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Trial record 32 of 84 for:    catechin

Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF) (HFPEF)

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ClinicalTrials.gov Identifier: NCT02068040
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Pam Taub, MD, University of California, San Diego

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Heart Failure Dietary Supplement: CocoaVia Not Applicable

Detailed Description:

Patient Inclusion/Exclusion Criteria:

  1. New York Heart Association Class II/III HF with preserved ejection fraction (EF) of >50%.
  2. Nonsmokers
  3. Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug eluting stent will not be excluded.
  4. Ages between 40-65. We will exclude any women of child bearing potential

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Cianidanol

Arm Intervention/treatment
Experimental: CocoaVia capsules
From baseline to 3 months, patients will consume 2 capsules containing pure epicatechin
Dietary Supplement: CocoaVia
CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol
Other Name: Epicatechin consumption




Primary Outcome Measures :
  1. Change from baseline in exercise capacity [ Time Frame: Baseline and 3 months ]
    Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max

  2. 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

  3. 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



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medically Diagnosed Heart Failure with Ejection Fraction of >55%
  • BMI 27-32
  • No Significant HbA1C fluctuations in past 6 months

Exclusion Criteria:

  • Smoking or quit smoking less than 1 year prior to enrollment
  • Substance Abuse
  • Taking Coudmadin or Pradaxa

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02068040


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego

Publications:
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Responsible Party: Pam Taub, MD, Dr. Pam Taub, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02068040     History of Changes
Other Study ID Numbers: UCSD IRB 130398
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Pam Taub, MD, University of California, San Diego:
with preserved ejection fraction of >55%

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases