Flavonols and Endothelial Injury

Endothelial Dysfunction Clinical Trial

— Radialis  

Official title:

Evaluation of Effects of Flavonols on Endothelial Function and Hyperplasia of Intima After Endothelium Injury During Transradial Catheter.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488823
• Other study ID #: 12-012
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: May 2018
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With increasing age, arterial endothelial cell function is impaired, which is associated with decreased regeneration response and increased intimal hyperplasia after endothelial injury. Dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact mechanism is unknown. Recent studies suggest that flavanols may affect important endothelial regeneration response processes and possibly mediate long-term positive vascular effects. The aim of this study is to investigate age-dependent mechanisms of impaired endothelial regeneration and the influence of dietary flavanols on them. For this purpose, younger and old male patients, who are clinically indicated for elective transradial catheterization, will get periinterventional a test drink , which is rich on flavonols (800 mg flavanols daily), or control drink. Administration of drinks is randomized and double-blind. The test drinks should be given one week before the elective catheter examination until 1 week later. The endothelial regeneration is to be investigated as endothelium-dependent vasodilation non-invasively in the area of the puncture site on the forearm and by means of biomarkers in the blood. The endothelial function of the Arteria radialis will be measured with Flow Mediated Dilation (FMD) before and 24 h after catheterization. One month after catheterization patients undergo ultrasound examination of arteria radialis, to include structural vessel wall changes as intimal media thickness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• planed catheterization, that has be done via Arteria radialis

Exclusion Criteria:

• acute infection (CRP>0.5 mg/dl)

• malignant diseases

• heart failure (NYHA III-IV)

• renal failure (GFR<60 ml/min)

• profoundly atrial fibrilation

• hypotension (=100/60 mmHg)

• intolerance of nitroglycerin

Related Conditions & MeSH terms

• Endothelial Dysfunction

Intervention

Dietary Supplement:
• with Flavanol
Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.
• without Flavanol
Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.

Locations

Country	Name	City	State
Germany	Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf	Duesseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Klinik für Kardiologie, Pneumologie und Angiologie

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Microvascular Function	Microvascular Function of Endothelium will be measured with Laser-Doppler Examination 1 month after catheterization	1 month
Primary	Increase of Endothelial Function of Arteria radialis	Change from Baseline Endothelial Function of Arteria radialis measured with Flow Mediated Dilation (FMD) after catheterization	week 2
Secondary	Degree of intimal Injury after Catheterization	Intimal Injury will be measured as intima media thickness with duplex sonography 1 month after catheterization	1 month