Comparison of Medical Therapies in Marfan Syndrome.

Phase 4

Completed

• Conditions: Marfan Syndrome
• Interventions: Drug: VERAPAMIL; Drug: Atenolol; Drug: Perindopril

• Registration Number: NCT01295047
• Lead Sponsor: Cardiff University

Brief Summary

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

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 Timeline

• Status Verified: 2006-01
• Study Start: 2006-07
• Primary Completion: 2007-12
• Study Completion: 2008-12
• Study First Submitted: 2011-02-11
• Study First Submitted QC: 2011-02-11
• Last Update Submitted: 2011-02-11
• Study First Posted: 2011-02-14
• Last Update Posted: 2011-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VERAPAMIL	VERAPAMIL	240MG VERAPAML FOR 4 WEEKS
ATENOLOL	Atenolol	ATENOLOL 75MG FOR 4 WEEKS
PERINDOPRIL	Perindopril	4MG PERINDOPRIL FOR 4 WEEKS

Primary Outcome Measures

Name	Time	Method
CENTRAL ARTERIAL PRESSURE	18 weeks	CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wales Heart Research Institute, Cardiff University; 🇬🇧 Cardiff, United Kingdom