Flavonols and Endothelial Injury

NCT ID: NCT03488823

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-04-30

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.

Conditions

Endothelial Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Young 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).

Group Type: EXPERIMENTAL

with Flavanol

Intervention Type: DIETARY_SUPPLEMENT

Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.

Young without Flavanol

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

Group Type: PLACEBO_COMPARATOR

without Flavanol

Intervention Type: DIETARY_SUPPLEMENT

Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.

Old 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).

Group Type: EXPERIMENTAL

with Flavanol

Intervention Type: DIETARY_SUPPLEMENT

Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.

Old without Flavanol

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

Group Type: PLACEBO_COMPARATOR

without Flavanol

Intervention Type: DIETARY_SUPPLEMENT

Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.

Interventions

with Flavanol

Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.

Intervention Type: DIETARY_SUPPLEMENT

without Flavanol

Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Klinik für Kardiologie, Pneumologie und Angiologie

OTHER

Sponsor Role: lead

Responsible Party

Klinik für Kardiologie, Pneumologie und Angiologie

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Roberto Sansone, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf

Locations

Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

12-012

Identifier Type: -

Identifier Source: org_study_id