Comparison of Medical Therapies in Marfan Syndrome.
Primary Purpose
Marfan Syndrome
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Atenolol
VERAPAMIL
Perindopril
Sponsored by
About this trial
This is an interventional treatment trial for Marfan Syndrome focused on measuring Marfan Syndrome, Large arterial function, LV function, atenolol, perindopril, verapamil, central arterial pressure
Eligibility Criteria
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
Sites / Locations
- Wales Heart Research Institute, Cardiff University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
ATENOLOL
VERAPAMIL
PERINDOPRIL
Arm Description
ATENOLOL 75MG FOR 4 WEEKS
240MG VERAPAML FOR 4 WEEKS
4MG PERINDOPRIL FOR 4 WEEKS
Outcomes
Primary Outcome Measures
CENTRAL ARTERIAL PRESSURE
CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY
Secondary Outcome Measures
LARGE ARTERIAL STIFFNESS INDICES
MEASURED BY ECHO AND BY PULSE WAVE VELOCITY/ANALYSIS BY APPLANATION TONOMETRY
LV Function
GLOBAL AND REGIONAL MARKERS BY ECHO
Full Information
NCT ID
NCT01295047
First Posted
February 11, 2011
Last Updated
February 11, 2011
Sponsor
Cardiff University
1. Study Identification
Unique Protocol Identification Number
NCT01295047
Brief Title
Comparison of Medical Therapies in Marfan Syndrome.
Official Title
Effects of Atenolol, Perindopril and Verapamil on Haemodynamic and Vascular Function in Marfan Syndrome - A Randomised Double-Blind Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cardiff University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marfan Syndrome
Keywords
Marfan Syndrome, Large arterial function, LV function, atenolol, perindopril, verapamil, central arterial pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATENOLOL
Arm Type
Active Comparator
Arm Description
ATENOLOL 75MG FOR 4 WEEKS
Arm Title
VERAPAMIL
Arm Type
Active Comparator
Arm Description
240MG VERAPAML FOR 4 WEEKS
Arm Title
PERINDOPRIL
Arm Type
Active Comparator
Arm Description
4MG PERINDOPRIL FOR 4 WEEKS
Intervention Type
Drug
Intervention Name(s)
Atenolol
Intervention Type
Drug
Intervention Name(s)
VERAPAMIL
Intervention Description
240 MG SR
Intervention Type
Drug
Intervention Name(s)
Perindopril
Intervention Description
4 MG
Primary Outcome Measure Information:
Title
CENTRAL ARTERIAL PRESSURE
Description
CENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
LARGE ARTERIAL STIFFNESS INDICES
Description
MEASURED BY ECHO AND BY PULSE WAVE VELOCITY/ANALYSIS BY APPLANATION TONOMETRY
Time Frame
18 WEEKS
Title
LV Function
Description
GLOBAL AND REGIONAL MARKERS BY ECHO
Time Frame
18 WEEKS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Wales Heart Research Institute, Cardiff University
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom
12. IPD Sharing Statement
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Comparison of Medical Therapies in Marfan Syndrome.
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