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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
---|---|
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00763893 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Multicenter, Randomised, Double Blind Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome |
Estimated Enrollment: | 300 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2013 |
Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Placebo Comparator |
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.
|
B: Active Comparator |
Drug: Losartan
50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg
|
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.
Ages Eligible for Study: | 10 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Guillaume JONDEAU, MD,PhD | 01 40 25 68 11 | guillaume.jondeau@bch.aphp.fr |
France | |
Hôpital Bichat | Recruiting |
Paris, France, 75018 | |
Contact: Guillaume JONDEAU, MD, PhD 01 40 25 68 11 guillaume.jondeau@bch.aphp.fr | |
Principal Investigator: Guillaume JONDEAU, MD,PhD |
Principal Investigator: | Guillaume JONDEAU, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Saliha Djane ) |
Study ID Numbers: | P060210, AOM 06056 |
Study First Received: | September 30, 2008 |
Last Updated: | April 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00763893 History of Changes |
Health Authority: | France: Ministry of Health |
Marfan syndrome Angiotensin II Type 1 Receptor Blockers Aortic Aneurysm, Thoracic |
Losartan Heart Diseases Aneurysm Aortic Aneurysm, Thoracic Dilatation, Pathologic Cardiovascular Abnormalities Cardiovascular Agents Antihypertensive Agents Angiotensin II Marfan Syndrome Bone Diseases Musculoskeletal Abnormalities |
Angiotensin II Type 1 Receptor Blockers Genetic Diseases, Inborn Musculoskeletal Diseases Connective Tissue Diseases Abnormalities, Multiple Bone Diseases, Developmental Anti-Arrhythmia Agents Aortic Aneurysm Congenital Abnormalities Heart Defects, Congenital Arachnodactyly |
Molecular Mechanisms of Pharmacological Action Bone Diseases Musculoskeletal Abnormalities Limb Deformities, Congenital Pathologic Processes Musculoskeletal Diseases Syndrome Therapeutic Uses Abnormalities, Multiple Bone Diseases, Developmental Connective Tissue Diseases Cardiovascular Diseases Anti-Arrhythmia Agents |
Congenital Abnormalities Losartan Heart Diseases Disease Cardiovascular Abnormalities Cardiovascular Agents Marfan Syndrome Antihypertensive Agents Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Genetic Diseases, Inborn Heart Defects, Congenital Arachnodactyly |