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A Randomised Double-Blind Trial of Medical Treatment In Marfan Syndrome.

A Randomised Double-Blind Trial of Medical Treatment In Marfan Syndrome.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-000749-13-GB
Enrollment
60
Registered
2005-06-20
Start date
2005-07-30
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Marfan Syndrome

Interventions

Trade Name: Atenolol Product Name: Atenolol Product Code: N/A Pharmaceutical Form: Capsule* INN or Proposed INN: N/A CAS

Sponsors

Cardiff University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Entry criteria: ? Clinical diagnosis of Marfan syndrome (Ghent criteria) ? Aged 16-50 years; either gender On no treatment for Marfan syndrome, or on beta-blocker or other monotherapy only Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: ? Previous aortic dissection or aortic surgery ? Severe aortic or mitral regurgitation; or cardiac disease unrelated to Marfan Syndrome ? Pregnancy, or of child-bearing age if at risk of pregnancy ? Aortic diameter at sinotubular junction = 5.0 cm ? Contraindications to specific drug treatment: e.g. asthma (?-blockers), or renal dysfunction defined as serum creatinine >150 µmol/l (ACE inhibitor)

Design outcomes

Primary

MeasureTime frame
Main Objective: In patients with Marfan syndrome: ? oral beta-blockade (atenolol) does not reduce central aortic stiffness or pressure ? ACE inhibition (perindopril) reduces central arterial pressure and improves aortic compliance ? a non-dihydropyridine calcium antagonist (verapamil) reduces rate of rise of arterial pressure, aortic stiffness, and central arterial pressure ? genotype affects the response to treatment ;Secondary Objective: ; Primary end point(s): The predefined primary end-points are beta index and aortic wave speed (indices of large artery stiffness), percentage augmentation (as a measure of central arterial pressure), and the amplitude of the forward compression wave (an index of myocardial contractile function).

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026