Effects of Chocolate on Coronary Vasomotion in Patients After Heart Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Dark chocolate

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Roberto Corti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Other Identifiers

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EK1129

Identifier Type: -

Identifier Source: org_study_id