The Impact of Dietary Flavanols on Cardiovascular Dysfunction in End-stage Renal Disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- End Stage Renal Disease
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Purpose of the study is to characterize the potential acute and long-term improvement of dietary flavanols on vascular function in patients with end-stage renal disease (ESRD).
Patients will twice daily receive either a flavanol-poor or a flavanol-rich drink. In a double blind, placebo-controlled crossover study the safety, efficacy and acute beneficial effects of flavanol ingestion will be assessed in 10 patients with ESRD. In a 30 day long-term, double blind, placebo-controlled parallel study the chronic effects of dietary flavanols on vascular function in 52 patients with ESRD will be evaluated.
Investigators
Klinik für Kardiologie, Pneumologie und Angiologie
Christos Rammos, MD Clinic for Cardiology, Pneumology and Angiology
Heinrich-Heine University, Duesseldorf
Eligibility Criteria
Inclusion Criteria
- •end stage renal disease
- •\>18 years
- •chronic intermittent hemodialysis
Exclusion Criteria
- •acute Infection
- •acute renal failure
- •heart failure (NYHA IV)
- •pregnancy
Outcomes
Primary Outcomes
The effect of flavanols on endothelial function as measured by flow-mediated dilation (FMD) after forearm ischemia and reperfusion.
Time Frame: 30 days
To study the effect of flavanols on flow mediated dilation of the brachial artery after 5 minutes of forearm ischemia and reperfusion in patients with ESRD