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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Marfan Syndrome Drug: placebo Drug: Losartan Phase 3

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.


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
Drug: Losartan
50 mg/day if < weight 50 kg 100 mg/day if weight > 50 kg



Primary Outcome Measures :
  1. normalised aortic diameter at the level of the sinus of valsalva [ Time Frame: every six months ]

Secondary Outcome Measures :
  1. 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, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00763893     History of Changes
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

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Marfan syndrome
Angiotensin II Type 1 Receptor Blockers
Aortic Aneurysm, Thoracic

Additional relevant MeSH terms:
Marfan Syndrome
Arachnodactyly
Syndrome
Disease
Pathologic Processes
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Losartan
Angiotensin II Type 1 Receptor Blockers
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action