Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation

This study has been completed.
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00521573
First received: August 27, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  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-Blind

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521573

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

No publications provided

ClinicalTrials.gov Identifier: NCT00521573     History of Changes
Other Study ID Numbers: EK1129
Study First Received: August 27, 2007
Last Updated: August 27, 2007
Health Authority: Switzerland: Swissmedic

ClinicalTrials.gov processed this record on April 17, 2014