Comparison of Medical Therapies in Marfan Syndrome.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- CENTRAL ARTERIAL PRESSURE [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY
- LARGE ARTERIAL STIFFNESS INDICES [ Time Frame: 18 WEEKS ] [ Designated as safety issue: No ]MEASURED BY ECHO AND BY PULSE WAVE VELOCITY/ANALYSIS BY APPLANATION TONOMETRY
- LV Function [ Time Frame: 18 WEEKS ] [ Designated as safety issue: No ]GLOBAL AND REGIONAL MARKERS BY ECHO
|Study Start Date:||July 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: ATENOLOL
ATENOLOL 75MG FOR 4 WEEKS
Active Comparator: VERAPAMIL
240MG VERAPAML FOR 4 WEEKS
240 MG SR
Active Comparator: PERINDOPRIL
4MG PERINDOPRIL FOR 4 WEEKS
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295047
|Wales Heart Research Institute, Cardiff University|
|Cardiff, United Kingdom, CF14 4XN|