Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome

Marfan Syndrome Clinical Trial

— MARFANSARTAN  

Official title:

Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00763893
• Other study ID #: P060210
• Secondary ID: 2006-006112-30
• Status: Terminated
• Phase: Phase 3
• First received: September 30, 2008
• Last updated: November 3, 2015
• Start date: September 2008
• Est. completion date: December 2014

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if losartan limits aortic dilatation in patients with Marfan syndrome.

Description:

Aim : evaluate the efficacy of losartan for limiting aortic dilatation in patients with marfan syndrome receiving standard therapy

Inclusion criteria :

10 years or older Marfan syndrome according to international criteria Signed informed consent

Non inclusion :

Previous surgery of the ascending aorta, or surgery planned Non echogenicity Contre-indication lactose Pregnancy on going or planned within 3 years Breast feeding Participation in another clinical study Non member of the social security or CMU

Number of subjects : the number of subjects (150 per group) is derived from the study from Shores et al (1994) demonstrating the benefit of beta-blockade in Marfan patient and uses a decrease by half of the aortic dilatation with losartan

Follow-up is 3 years, after inclusion period of 2 years. A total of 5 years is expected

Methods : randomised double blind vs placebo study. All French centres de competence for marfan syndrome and the centre de reference are participating in the study.

End points : main endpoint is evolution of normalised aortic diameter. Secondary endpoints include clinical events (cardiac surgery or aortic dissection, hospitalisation in cardiology department, death), tolerance of the drug, and quality of life.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 303
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• 10 years or older

• Marfan syndrome according to international criteria Signed informed consent

Exclusion Criteria:

• Previous surgery of the ascending aorta, or surgery planned

• Non echogenicity

• Contre-indication lactose

• Pregnancy on going or planned within 3 years

• Breast feeding

• Participation in another clinical study

• Non member of the social security or CMU

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marfan Syndrome
• Syndrome

Intervention

Drug:
• placebo
Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). For example, interventions involving drugs may include dosage form, dosage, frequency and duration.
• Losartan
50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg

Locations

Country	Name	City	State
France	Hôpital Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Detaint D, Aegerter P, Tubach F, Hoffman I, Plauchu H, Dulac Y, Faivre LO, Delrue MA, Collignon P, Odent S, Tchitchinadze M, Bouffard C, Arnoult F, Gautier M, Boileau C, Jondeau G. Rationale and design of a randomized clinical trial (Marfan Sartan) of ang — View Citation

Milleron O, Arnoult F, Ropers J, Aegerter P, Detaint D, Delorme G, Attias D, Tubach F, Dupuis-Girod S, Plauchu H, Barthelet M, Sassolas F, Pangaud N, Naudion S, Thomas-Chabaneix J, Dulac Y, Edouard T, Wolf JE, Faivre L, Odent S, Basquin A, Habib G, Collig — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	normalised aortic diameter at the level of the sinus of valsalva		every six months	Yes
Secondary	cardiac surgery, hospitalisation in cardiology ward, death		during the follow up	Yes