Comparison of Medical Therapies in Marfan Syndrome.

February 11, 2011 updated by: Cardiff University

Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome - A Randomised Double-Blind Crossover Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XN
        • Wales Heart Research Institute, Cardiff University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ATENOLOL
ATENOLOL 75MG FOR 4 WEEKS
Drug: Atenolol
Active Comparator: VERAPAMIL
240MG VERAPAML FOR 4 WEEKS
Drug: VERAPAMIL
240 MG SR
Active Comparator: PERINDOPRIL
4MG PERINDOPRIL FOR 4 WEEKS
Drug: Perindopril
4 MG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CENTRAL ARTERIAL PRESSURE
Time Frame: 18 weeks
CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY
18 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 11, 2011

First Posted (Estimate)

February 14, 2011

Study Record Updates

Last Update Posted (Estimate)

February 14, 2011

Last Update Submitted That Met QC Criteria

February 11, 2011

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPONCU101
  • 2005-000749-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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