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Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation

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ClinicalTrials.gov Identifier: NCT00521573
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : August 28, 2007
Sponsor:
Information provided by:
University of Zurich

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
Heart Transplantation 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 Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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

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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): NCT00521573


Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Roberto Corti, MD University of Zurich

ClinicalTrials.gov Identifier: NCT00521573     History of Changes
Other Study ID Numbers: EK1129
First Posted: August 28, 2007    Key Record Dates
Last Update Posted: August 28, 2007
Last Verified: August 2007