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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Dietary Supplement: CocoaVia

• Registration Number: NCT02068040
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-02-18
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-20
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CocoaVia capsules	CocoaVia	From baseline to 3 months, patients will consume 2 capsules containing pure epicatechin

Primary Outcome Measures

Name	Time	Method
Change from baseline in pre-specified biomarker levels in blood, skeletal muscle, and urine	Baseline and 3 months	Skeletal muscle biopsies and blood draws will be performed to obtain experimental samples
Change from baseline in exercise capacity	Baseline and 3 months	Objectively evaluate exercise capacity through cycle ergometry to measure VO2 max
Change from baseline in skeletal muscle metabolism	Baseline and 3 months	The change in skeletal muscle metabolism will be evaluated by magnetic resonance spectroscopy

Trial Locations

Locations (1)

University of California, San Diego; 🇺🇸 La Jolla, California, United States