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Comparison of Medical Therapies in Marfan Syndrome.

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01295047
Enrollment
18
Registered
2011-02-14
Start date
2006-07-31
Completion date
2008-12-31
Last updated
2011-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marfan Syndrome

Keywords

Marfan Syndrome, Large arterial function, LV function, atenolol, perindopril, verapamil, central arterial pressure

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.

Interventions

DRUGAtenolol
DRUGVERAPAMIL

240 MG SR

DRUGPerindopril

4 MG

Sponsors

Cardiff University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CENTRAL ARTERIAL PRESSURE18 weeksCENTRAL ARTERIAL PRESSURE MEASURED BY APPLANATION TONOMETRY

Secondary

MeasureTime frameDescription
LARGE ARTERIAL STIFFNESS INDICES18 WEEKSMEASURED BY ECHO AND BY PULSE WAVE VELOCITY/ANALYSIS BY APPLANATION TONOMETRY
LV Function18 WEEKSGLOBAL AND REGIONAL MARKERS BY ECHO

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026