- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00835887
Relevance of Flavanols for Cardiovascular Function in End-Stage Renal Disease (ESRD)
Relevance of Flavanols for Cardiovascular Function in End-Stage Renal Disease, a Phase 2 Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Düsseldorf, Germany
- Düsseldorf University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with end stage renal disease
Exclusion Criteria:
- person under 18 years of age
- participation in another study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Treatment with low dose flavanoids
|
treatment with flavanoid-rich or flavanoid-low cacao twice daily
|
Experimental: 2
Treatment with high dose flavanoids
|
treatment with flavanoid-rich or flavanoid-low cacao twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Vascular function
Time Frame: before treatment, directly after treatment and 3, resp. 4 months afterwards
|
before treatment, directly after treatment and 3, resp. 4 months afterwards
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESRD-Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on End Stage Renal Disease
-
Outset MedicalCompletedAcute Kidney Injury | End Stage Renal Disease (ESRD) | End Stage Renal Disease on DialysisUnited States
-
University of Illinois at ChicagoWithdrawnObesity | End-Stage Renal Disease | Renal Disease, End-Stage | Renal Failure, End-StageUnited States
-
Bioconnect Systems, IncCompletedEnd-stage Renal Disease | End-stage Kidney DiseaseUnited States
-
Xinhua Hospital, Shanghai Jiao Tong University...Changhai Hospital; Shanghai Zhongshan Hospital; RenJi Hospital; Ruijin Hospital; Shanghai... and other collaboratorsCompleted
-
Clinical Research Center for End Stage Renal Disease...Kyungpook National University Hospital; Medical Research Collaborating Center... and other collaboratorsActive, not recruitingEnd-Stage Renal DiseaseKorea, Republic of
-
Medtronic - MITGCompletedEnd-stage Renal DiseaseGermany
-
China Medical University HospitalUnknown
-
Guangdong Provincial Hospital of Traditional Chinese...Ministry of Science and Technology of the People´s Republic of ChinaUnknown
-
University of California, San FranciscoCompletedEnd-stage Renal DiseaseUnited States
-
Mark A. LumleyHenry Ford Health SystemCompleted
Clinical Trials on low and high dose flavanoids
-
RWTH Aachen UniversityHeinrich-Heine University, DuesseldorfWithdrawnPeripheral Artery DiseaseGermany
-
MedImmune LLCCompletedNon-alcoholic Fatty Liver Disease (NAFLD) | Non-alcoholic Steatohepatitis (NASH)United States, Puerto Rico
-
National Institute of Diabetes and Digestive and...Washington University School of Medicine; University of Alabama at Birmingham; Icahn School of Medicine at Mount Sinai and other collaboratorsCompletedEnd Stage Renal DiseaseUnited States
-
Beijing Northland Biotech. Co., Ltd.CompletedSafety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.InfarctionAcute Myocardial InfarctionChina
-
Columbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
VA Office of Research and DevelopmentTerminatedAtherosclerosis | Anemia | CKD | CardiovascularUnited States
-
Tatyana ZubkovaSt. Petersburg State Pavlov Medical University; MDP-CRO, LLCCompletedCOVID-19Russian Federation
-
University Hospital, Basel, SwitzerlandCompletedFemale Infertility | Ovarian InsufficiencySwitzerland
-
University of OxfordMedical Research CouncilTerminatedHIV-1United Kingdom
-
Yiling Pharmaceutical Inc.CompletedPharmacokinetics | Healthy Adult Subjects | Safety and TolerabilityUnited States