Comparison of Medical Therapies in Marfan Syndrome.

Overview

The investigators are looking at the different impacts of atenolol, verapamil and perindopril on large artery and lv function in marfan syndrome. It is a double-blind, randomised cross-over trial.

Full Title of Study: “Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome – A Randomised Double-Blind Crossover Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2007

Detailed Description

The investigators recruited 21 patients with confirmed diagnosis of Marfan syndrome from two centres. The investigators performed radial artery applanation tonometry and pulse wave analysis to derive central aortic pressure and haemodynamic indexes pre-and post administering Atenolol 75mg, Perindopril 4mg and Verapamil 240mgs each for four weeks with a two week wash-out between medications. All patients underwent detailed functional and anatomical echocardiographic assessments at each visit. Inclusion criteria were ages 16-60 years with no treatment or β-blocker or other monotherapy only for Marfan syndrome. Patients with previous aortic dissection or aortic surgery, severe valvular regurgitation, aortic diameter at the sinotubular junction ≥ 5.0cm, contraindications to specific drug treatment, e.g. asthma and β-blocker, or those who were pregnant or at risk of pregnancy were excluded.

Interventions

  • Drug: Atenolol
  • Drug: VERAPAMIL
    • 240 MG SR
  • Drug: Perindopril
    • 4 MG

Arms, Groups and Cohorts

  • Active Comparator: ATENOLOL
    • ATENOLOL 75MG FOR 4 WEEKS
  • Active Comparator: VERAPAMIL
    • 240MG VERAPAML FOR 4 WEEKS
  • Active Comparator: PERINDOPRIL
    • 4MG PERINDOPRIL FOR 4 WEEKS

Clinical Trial Outcome Measures

Primary Measures

  • CENTRAL ARTERIAL PRESSURE
    • Time Frame: 18 weeks
    • CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY

Secondary Measures

  • LARGE ARTERIAL STIFFNESS INDICES
    • Time Frame: 18 WEEKS
    • MEASURED BY ECHO AND BY PULSE WAVE VELOCITY/ANALYSIS BY APPLANATION TONOMETRY
  • LV Function
    • Time Frame: 18 WEEKS
    • GLOBAL AND REGIONAL MARKERS BY ECHO

Participating in This Clinical Trial

Inclusion Criteria

  • Ages 16-60 years old with no treatment or β-blocker or other monotherapy only for Marfan syndrome Exclusion Criteria:

  • Previous aortic dissection or aortic surgery – Severe valvular regurgitation – Aortic diameter at the sinotubular junction ≥ 5.0cm – Contraindications to specific drug treatment, e.g. asthma and β-blocker – Those who were pregnant or at risk of pregnancy

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cardiff University
  • Provider of Information About this Clinical Study
    • DR ALAN FRASER, WALES HEART RESEARCH INSTITUTE

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.