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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2005-000749-13-GB
• Date of registration: 20/06/2005
• Prospective Registration: Yes
• Primary sponsor: Cardiff University
• Public title: A Randomised Double-Blind Trial of Medical Treatment In Marfan Syndrome.
• Scientific title: A Randomised Double-Blind Trial of Medical Treatment In Marfan Syndrome.
• Date of first enrolment: 30/07/2005
• Target sample size: 60
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000749-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: Single blind: Double blind: yes; Parallel group: Cross over: yes; Other: If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

United Kingdom

Key inclusion & exclusion 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:
? 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)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Marfan Syndrome

Intervention(s)

Trade Name: Atenolol
Product Name: Atenolol
Product Code: N/A
Pharmaceutical Form: Capsule*
INN or Proposed INN: N/A
CAS Number: -29122-68-7
Current Sponsor code: CO7AB03
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75 MG ONCE DAILY-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Coversyl
Product Name: Coversyl
Product Code: N/A
Pharmaceutical Form: Capsule*
INN or Proposed INN: N/A
CAS Number: -95153-31-4
Current Sponsor code: CO9AA04
Other descriptive name: PERINDOPRIL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4MG ONCE DAILY
-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Verapamil
SR
Product Name: Verapamil SR
Product Code: N/A
Pharmaceutical Form: Capsule*
INN or Proposed INN: N/A
CAS Number: -152-11-4
Current Sponsor code: CO8DA01
Other descriptive name: N/A
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 240 MG ONCE DAILY-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

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).

Secondary ID(s)

N/A

SPON CU 101

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 16/06/2019
• Date Completed: 01/05/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2005-000749-13/results