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Role of Calcium Channels in Vascular Function

Sponsor
University of Southern Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT02885558
Collaborator
(none)
12
Enrollment
2
Locations
2
Arms
42.7
Actual Duration (Months)
6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the role of T-type calcium channels in endothelial dysfunction observed with ageing.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Role of T-type Calcium Channels in Vascular Function
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
May 25, 2021
Actual Study Completion Date :
May 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: L + T-type

8 weeks treatment with efonidipine (1 week 1x20mg, 7 weeks 2x20mg)

Drug: Efonidipine
8 weeks treatment with either efonidipine
Other Names:
  • Landel (efonidipine)

    		•
    Active Comparator: L-Type

    8 weeks treatment with nifedipine (1 week 1x20mg, 7 weeks 2x20mg)

    Drug: Nifedipine
    8 weeks treatment with either nifedipine
    Other Names:
  • Adalat (nifedipine)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vascular function [8 weeks]

      Hemodynamic response to femoral arterially infused vasoactive substances

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • age 20 - 30 and 60-70

    • BMI < 30

    Exclusion Criteria:

    • Hypertension (>150/90 mmHg)

    • Smoking

    • Physical activity >2 hours/week

    • Known chronic diseases

    • Pregnancy or birth within 3 month

    • Alcohol misuse

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre for Phsical Activity Research Copenhagen Denmark 2100
    2 Cardiovascular and Renal Research Odense Denmark 5000

    Sponsors and Collaborators

    • University of Southern Denmark

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefan Mortensen, Associate Professor, University of Southern Denmark
    ClinicalTrials.gov Identifier:
    NCT02885558
    Other Study ID Numbers:
    • 47880
    First Posted:
    Aug 31, 2016
    Last Update Posted:
    Jun 1, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Stefan Mortensen, Associate Professor, University of Southern Denmark
    Receptors, Calcium Channel Blocker
    Additional relevant MeSH terms:
    Efonidipine
    Nifedipine

    Study Results

    No Results Posted as of Jun 1, 2021