Relevance of Flavanols for Cardiovascular Function in End-Stage Renal Disease

End Stage Renal Disease Clinical Trial

— ESRD  

Official title:

Relevance of Flavanols for Cardiovascular Function in End-Stage Renal Disease, a Phase 2 Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00835887
• Other study ID #: ESRD-Study
• Status: Withdrawn
• Phase: Phase 2
• First received: February 3, 2009
• Last updated: September 22, 2015

Study information

• Verified date: September 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

In this study, the acute and long-term effects of flavanols on vascular function in patients with ESRD will be investigated.

Description:

In order to assess potential acute beneficial effects of flavanols in patients with ESRD, 10 patients undergoing dialysis will be recruited. Subjects will receive a cocoa drink with 16 mg, 250 mg, and 500 mg (in 100 mL water each) flavan-3-ols (40% epicatechine/catechine und 60% procyanidine), respectively, on three consecutively days. The functional/hemodynamic parameters (flowmediated dilation (FMD), venous-occlusion-plethysmography (VOP), blood pressure, heart rate), the biochemical marker of the circulating NO pool (nitrite, nitrate, RNOs), and the plasma levels of flavanols (epicatechine and catechine) will be determined before and after ingestion of the respective cocoadrink.

It is expected that flavanols dose-dependently improve vascular function and that this is associated with an increase in the circulating NO pool.

In order to assess long-term effects of flavanols on vascular function in patients with ESRD.

To characterize potential vascular long-term effects of flavanols in patients with ESRD, a placebo-controlled double-blinded randomized control study will be performed in 40 patients randomized in two groups. Patients will daily receive either a flavanol-poor cocoa drink or a flavanol-rich cocoa drink over a period of three months.

The flavanol-dosis that is necessary to affect vascular function will be assessed as described above. At the beginning of the study, after the first intake of the cocoa (in order to identify nonresponders) and monthly for a period of three months the vascular function will be assessed applying innovative imaging techniques to the brachial artery to assess endothelium-dependent regulation of physicomechanical properties and vascular tone and thus blood flow at the level of the macrocirculation. In parallel new techniques will be applied to assess perfusion at the level of the microcirculation. In particular, measurement of flow-mediated dilation, intima-media-thickness,compliance and stiffness indices will be performed in the macrocirculation of the brachial artery.

Considering the microcirculation, new diagnostic approaches such as Laser-Doppler Flow and peripheral arterial tonometry next to diagnostic approaches such as the venous occlusive plethysmography will be performed. Moreover, the circulating NO pool, markers of inflammation and of oxidative stress, the uremic toxin pcresol and the plasma levels of flavanols will be determined. The exams after month 1, 2, and 3 will be performed in the morning before intake of the cocoa drink. In order to examine potential sustained effects, an additional examination day will take place after 4 month (one month after stopping the flavanol-intake). It is expected that the flavanol-rich cocoa will improve vascular function, which is associated with an increase in the circulating NO-pool and a decrease in inflammatory markers and the marker for oxidative stress.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with end stage renal disease

Exclusion Criteria:

• person under 18 years of age

• participation in another study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• low and high dose flavanoids
treatment with flavanoid-rich or flavanoid-low cacao twice daily

Locations

Country	Name	City	State
Germany	Düsseldorf University Hospital	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
RWTH Aachen University	Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular function		before treatment, directly after treatment and 3, resp. 4 months afterwards	No