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Completed

NCT Number: NCT02068040

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego

La Jolla, California, 92093, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CocoaVia

Dietary Supplement

CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol

Other names: Epicatechin consumption

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Acronym: HFPEF

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 20, 2014
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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