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NCT00521573 Clinical Trial

Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation

Heart Transplantation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00521573
Other study ID # EK1129
Secondary ID
Status Completed
Phase Phase 1
First received August 27, 2007
Last updated August 27, 2007

Study information
Verified date August 2007
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Other:
• Dark chocolate

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Zurich
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