NCT00521573

Brief 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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
Last Updated

August 28, 2007

Status Verified

August 1, 2007

First QC Date

August 27, 2007

Last Update Submit

August 27, 2007

Conditions

Heart Transplantation

Interventions

Dark chocolateOTHER

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients after heart transplantation not requiring immediate coronary intervention
  • Age 20 - 80
  • Written obtained informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Roberto Corti, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2007

First Posted

August 28, 2007

Last Updated

August 28, 2007

Record last verified: 2007-08