Comparison of Medical Therapies in Marfan Syndrome.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Marfan Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ATENOLOL

ATENOLOL 75MG FOR 4 WEEKS

Group Type ACTIVE_COMPARATOR

Atenolol

Intervention Type DRUG

VERAPAMIL

240MG VERAPAML FOR 4 WEEKS

Group Type ACTIVE_COMPARATOR

VERAPAMIL

Intervention Type DRUG

240 MG SR

PERINDOPRIL

4MG PERINDOPRIL FOR 4 WEEKS

Group Type ACTIVE_COMPARATOR

Perindopril

Intervention Type DRUG

4 MG

Interventions

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Atenolol

Intervention Type DRUG

VERAPAMIL

240 MG SR

Intervention Type DRUG

Perindopril

4 MG

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No