Flavonols and Endothelial Injury (Radialis)

Klinik für Kardiologie, Pneumologie und Angiologie

Status: Completed

Conditions: Endothelial Dysfunction

Treatments: Dietary Supplement: without Flavanol; Dietary Supplement: with Flavanol

Study type: Interventional

Funder types: Other

Identifiers

NCT03488823

12-012

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Young with Flavanol

Experimental group

Description:

Young patients (\< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols).

Treatment:

Dietary Supplement: with Flavanol

Young without Flavanol

Placebo Comparator group

Description:

Young patients (\< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols .

Treatment:

Dietary Supplement: without Flavanol

Old with Flavanol

Experimental group

Description:

Old patients (\>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols).

Treatment:

Dietary Supplement: with Flavanol

Old without Flavanol

Placebo Comparator group

Description:

Young patients (\>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols.

Treatment:

Dietary Supplement: without Flavanol