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Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00521573
First Posted: August 28, 2007
Last Update Posted: August 28, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Zurich
  Purpose
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 Intervention Phase
Heart Transplantation Other: Dark chocolate Phase 1

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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
Information from the National Library of Medicine

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
  More Information

ClinicalTrials.gov Identifier: NCT00521573     History of Changes
Other Study ID Numbers: EK1129
First Submitted: August 27, 2007
First Posted: August 28, 2007
Last Update Posted: August 28, 2007
Last Verified: August 2007