Comparison of Medical Therapies in Marfan Syndrome.

Marfan Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295047
• Other study ID #: SPONCU101
• Secondary ID: 2005-000749-13
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2011
• Last updated: February 11, 2011
• Start date: July 2006
• Est. completion date: December 2008

Study information

• Verified date: January 2006
• Source: Cardiff University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

• Ages 16-60 years old with no treatment or ß-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 ß-blocker

• Those who were pregnant or at risk of pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marfan Syndrome
• Syndrome

Intervention

Drug:
• Atenolol

• VERAPAMIL
240 MG SR
• Perindopril
4 MG

Locations

Country	Name	City	State
United Kingdom	Wales Heart Research Institute, Cardiff University	Cardiff

Sponsors (1)

Lead Sponsor	Collaborator
Cardiff University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CENTRAL ARTERIAL PRESSURE	CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY	18 weeks	No
Secondary	LARGE ARTERIAL STIFFNESS INDICES	MEASURED BY ECHO AND BY PULSE WAVE VELOCITY/ANALYSIS BY APPLANATION TONOMETRY	18 WEEKS	No
Secondary	LV Function	GLOBAL AND REGIONAL MARKERS BY ECHO	18 WEEKS	No