Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation

August 27, 2007 updated by: University of Zurich
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (Estimate)

August 28, 2007

Study Record Updates

Last Update Posted (Estimate)

August 28, 2007

Last Update Submitted That Met QC Criteria

August 27, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • EK1129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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