Comparison of Medical Therapies in Marfan Syndrome.

Sponsor

Cardiff University (Other)

Overall Status

Completed

CT.gov ID

NCT01295047

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Marfan Syndrome	Drug: Atenolol Drug: VERAPAMIL Drug: Perindopril	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

CENTRAL ARTERIAL PRESSURE [18 weeks]
CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY

Secondary Outcome Measures

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