Flavonols and Endothelial Injury

NCT03488823 | Completed

• 1 other identifier: 12-012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Endothelial Function; Flavonols; Intima Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Degree of intimal Injury after Catheterization

  1 month

Other Outcomes (1)

• Microvascular Function

  1 month

Study Arms (4)

Young with Flavanol

EXPERIMENTAL

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

Dietary Supplement: with Flavanol

Young without Flavanol

PLACEBO COMPARATOR

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

Dietary Supplement: without Flavanol

Old with Flavanol

EXPERIMENTAL

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

Dietary Supplement: with Flavanol

Old without Flavanol

PLACEBO COMPARATOR

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

Dietary Supplement: without Flavanol

Interventions

with Flavanol DIETARY_SUPPLEMENT

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

Old with Flavanol; Young with Flavanol

without Flavanol DIETARY_SUPPLEMENT

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

Old without Flavanol; Young without Flavanol

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• planed catheterization, that has be done via Arteria radialis

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinik für Kardiologie, Pneumologie und Angiologie: lead

Study Sites (1)

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

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Study Officials

• Roberto Sansone, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: April 5, 2018
• Study Start: November 1, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

DE (1)