Comparison of Medical Therapies in Marfan Syndrome.

Cardiff University

Status and phase: Completed; Phase 4

Conditions: Marfan Syndrome

Treatments: Drug: Atenolol; Drug: Perindopril; Drug: VERAPAMIL

Study type: Interventional

Funder types: Other

Identifiers

NCT01295047

SPONCU101

2005-000749-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 3 patient groups

ATENOLOL

Active Comparator group

Description:

ATENOLOL 75MG FOR 4 WEEKS

Treatment:

Drug: Atenolol

VERAPAMIL

Active Comparator group

Description:

240MG VERAPAML FOR 4 WEEKS

Treatment:

Drug: VERAPAMIL

PERINDOPRIL

Active Comparator group

Description:

4MG PERINDOPRIL FOR 4 WEEKS

Treatment:

Drug: Perindopril