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

This study has been terminated.

(A similar publication has been released, suggesting a beneficial effect of sartans, and only 15 patients remained to be seen for their visit at 36 months.)

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00763893

First received: September 30, 2008

Last updated: December 19, 2014

Last verified: December 2014

History of Changes

Purpose

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

Condition	Intervention	Phase
Marfan Syndrome	Drug: placebo Drug: Losartan	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: familial thoracic aortic aneurysm and dissection Marfan syndrome

MedlinePlus related topics: Marfan Syndrome

Drug Information available for: Losartan Losartan potassium

Genetic and Rare Diseases Information Center resources: Marfan Syndrome

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

normalised aortic diameter at the level of the sinus of valsalva [ Time Frame: every six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

cardiac surgery, hospitalisation in cardiology ward, death [ Time Frame: during the follow up ] [ Designated as safety issue: Yes ]


Enrollment:	303
Study Start Date:	September 2008
Study Completion Date:	December 2014
Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: A: Placebo placebo	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. Other Name: placebo
Active Comparator: B: Losartan Losartan	Drug: Losartan 50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg Other Name: Losartan

Detailed 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.

Eligibility


Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763893

Locations


France
Hôpital Bichat
Paris, France, 75018

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators


Principal Investigator:	Guillaume JONDEAU, MD, PhD	Assistance Publique - Hôpitaux de Paris

More Information

Publications:

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 angiotensin II receptor blocker therapy versus placebo in individuals with Marfan syndrome. Arch Cardiovasc Dis. 2010 May;103(5):317-25. doi: 10.1016/j.acvd.2010.04.008. Epub 2010 Jul 1.


Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00763893 History of Changes
Other Study ID Numbers:	P060210, 2006-006112-30
Study First Received:	September 30, 2008
Last Updated:	December 19, 2014
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:


Marfan syndrome Angiotensin II Type 1 Receptor Blockers Aortic Aneurysm, Thoracic

Additional relevant MeSH terms:


Arachnodactyly Marfan Syndrome Abnormalities, Multiple Bone Diseases Bone Diseases, Developmental Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases	Limb Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Losartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Anti-Arrhythmia Agents Antihypertensive Agents Cardiovascular Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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