NCT Number: NCT00521573
Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation
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.
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Notify MeKey information
Conditions
Age range
20 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients after heart transplantation not requiring immediate coronary intervention
- Age 20 - 80
- Written obtained informed consent
Exclusion criteria
- Heart failure (acute or chronic >NYHA II)
- Ventricular tachy-arrythmias or AV-Block >I°
- Renal insufficiency (>200 μmol/l) or liver disease (ALT or AST >150 IU)
- Symptomatic hypotension, hypertension >160/100mmHg
- Known allergy to compounds dark chocolate
- Acute infectious disease
- Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
- Participation in another study within the last month
- Concomitant vitamin supplements
Treatment and study plan
Sponsors and collaborators
Lead sponsor
University of Zurich
Other
Registry information
Important dates
- First posted
- Aug 28, 2007
- Registry last updated
- Aug 28, 2007
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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