Heart Failure
Conditions
Keywords
with preserved ejection fraction of >55%
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
Interventions
DIETARY_SUPPLEMENTCocoaVia
CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol
Sponsors
University of California, San Diego
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed