Comparison of Medical Therapies in Marfan Syndrome.
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|ClinicalTrials.gov Identifier: NCT01295047|
Recruitment Status : Completed
First Posted : February 14, 2011
Last Update Posted : February 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|Marfan Syndrome||Drug: Atenolol Drug: VERAPAMIL Drug: Perindopril||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||July 2006|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2008|
U.S. FDA Resources
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
- CENTRAL ARTERIAL PRESSURE [ Time Frame: 18 weeks ]CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY
- LARGE ARTERIAL STIFFNESS INDICES [ Time Frame: 18 WEEKS ]MEASURED BY ECHO AND BY PULSE WAVE VELOCITY/ANALYSIS BY APPLANATION TONOMETRY
- LV Function [ Time Frame: 18 WEEKS ]GLOBAL AND REGIONAL MARKERS BY ECHO
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295047
|Wales Heart Research Institute, Cardiff University|
|Cardiff, United Kingdom, CF14 4XN|