Flavonols and Endothelial Injury (Radialis)

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

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.

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: with Flavanol; Dietary supplement: without Flavanol

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Duesseldorf, NRW, Germany, 40225
      • Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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.
Placebo Comparator: Young without Flavanol; Young patients (< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols .	Dietary supplement: without Flavanol; Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.
Experimental: 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).	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.
Placebo Comparator: Old without Flavanol; Young patients (>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols.	Dietary supplement: without Flavanol; Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of intimal Injury after Catheterization	Intimal Injury will be measured as intima media thickness with duplex sonography 1 month after catheterization	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Microvascular Function	Microvascular Function of Endothelium will be measured with Laser-Doppler Examination 1 month after catheterization	1 month

Collaborators and Investigators

• Sponsor: Klinik für Kardiologie, Pneumologie und Angiologie
• Investigators: Principal Investigator: Roberto Sansone, MD, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): April 30, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: February 15, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 14, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Endothelial Function; Flavonols; Intima Injury
• Other Study ID Numbers: 12-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No