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Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation

Sponsor
University of Zurich (Other)
Overall Status
Completed
CT.gov ID
NCT00521573
Collaborator
(none)

Study Details

Study Description

Brief Summary

The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.

Condition or Disease Intervention/Treatment Phase
  • Other: Dark chocolate
 Phase 1

Detailed Description

Dark chocolate contains a high amount of flavonoids. Flavonoids hold the possibilities to improve oxidative stress and hence the possibility to improve endothelium-dependent coronary vasomotion, which is a powerful surrogate for clinical prognosis. Coronary atherosclerosis is promoted by impaired endothelial function and increased platelet activation. High oxidative stress and reduced antioxidant defenses play a crucial role in the pathogenesis of atherosclerosis, in particular in transplanted hearts. The aim of the present study is to investigate whether the ingestion of a flavonoid-rich dark chocolate compared to flavonoid-free placebo chocolate will improve coronary vasomotion in heart transplanted patients.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Patients after heart transplantation not requiring immediate coronary intervention

    2. Age 20 - 80

    3. Written obtained informed consent

    Exclusion Criteria:

    1. Heart failure (acute or chronic >NYHA II)

    2. Ventricular tachy-arrythmias or AV-Block >I°

    3. Renal insufficiency (>200 μmol/l) or liver disease (ALT or AST >150 IU)

    4. Symptomatic hypotension, hypertension >160/100mmHg

    5. Known allergy to compounds dark chocolate

    6. Acute infectious disease

    7. Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)

    8. Participation in another study within the last month

    9. Concomitant vitamin supplements

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Zurich

    Investigators

    • Principal Investigator: Roberto Corti, MD, University of Zurich

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00521573
    Other Study ID Numbers:
    • EK1129
    First Posted:
    Aug 28, 2007
    Last Update Posted:
    Aug 28, 2007
    Last Verified:
    Aug 1, 2007

    Study Results

    No Results Posted as of Aug 28, 2007