Flavonols and Endothelial Injury

Not Applicable

Completed

• Conditions: Endothelial Dysfunction
• Interventions: Dietary Supplement: with Flavanol; Dietary Supplement: without Flavanol

• Registration Number: NCT03488823
• Lead Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-02-15
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-05
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Young with Flavanol	with Flavanol	Young patients (\< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols).
Young without Flavanol	without Flavanol	Young patients (\< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols .
Old with Flavanol	with Flavanol	Old patients (\>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols).
Old without Flavanol	without Flavanol	Young patients (\>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols.

Primary Outcome Measures

Name	Time	Method
Increase of Endothelial Function of Arteria radialis	week 2	Change from Baseline Endothelial Function of Arteria radialis measured with Flow Mediated Dilation (FMD) after catheterization

Secondary Outcome Measures

Name	Time	Method
Degree of intimal Injury after Catheterization	1 month	Intimal Injury will be measured as intima media thickness with duplex sonography 1 month after catheterization

Trial Locations

Locations (1)

Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf; 🇩🇪 Duesseldorf, NRW, Germany