Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome (MARFANSARTAN)
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ClinicalTrials.gov Identifier: NCT00763893 |
Recruitment Status :
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.)
First Posted : October 1, 2008
Last Update Posted : November 4, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Marfan Syndrome | Drug: placebo Drug: Losartan | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 303 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
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. |
Active Comparator: B: Losartan
Losartan
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Drug: Losartan
50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg |
- normalised aortic diameter at the level of the sinus of valsalva [ Time Frame: every six months ]
- cardiac surgery, hospitalisation in cardiology ward, death [ Time Frame: during the follow up ]

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Ages Eligible for Study: | 10 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763893
France | |
Hôpital Bichat | |
Paris, France, 75018 |
Principal Investigator: | Guillaume JONDEAU, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00763893 |
Other Study ID Numbers: |
P060210 2006-006112-30 ( EudraCT Number ) |
First Posted: | October 1, 2008 Key Record Dates |
Last Update Posted: | November 4, 2015 |
Last Verified: | October 2015 |
Marfan syndrome Angiotensin II Type 1 Receptor Blockers Aortic Aneurysm, Thoracic |
Marfan Syndrome Arachnodactyly Syndrome Disease Pathologic Processes Cardiovascular Diseases Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Heart Defects, Congenital Cardiovascular Abnormalities Heart Diseases |
Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Connective Tissue Diseases Limb Deformities, Congenital Musculoskeletal Abnormalities Losartan Anti-Arrhythmia Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |