Comparison of Medical Therapies in Marfan Syndrome.

Study Overview
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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.

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.

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

Conditions
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Marfan Syndrome

Intervention / Treatment
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* Drug: Atenolol
* Drug: VERAPAMIL
* Drug: Perindopril


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ATENOLOL<br>ATENOLOL 75MG FOR 4 WEEKS | Drug: Atenolol<br> <br> |
| Active Comparator: VERAPAMIL<br>240MG VERAPAML FOR 4 WEEKS | Drug: VERAPAMIL<br>* 240 MG SR<br>|
| Active Comparator: PERINDOPRIL<br>4MG PERINDOPRIL FOR 4 WEEKS | Drug: Perindopril<br>* 4 MG<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Marfan Syndrome, Large arterial function, LV function, atenolol, perindopril, verapamil, central arterial pressure