Full Text View
Tabular View
No Study Results Posted
Related Studies
Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome (MARFANSARTAN)
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, August 2008
First Received: September 30, 2008   Last Updated: April 1, 2009   History of Changes
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00763893
  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 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

Resource links provided by NLM:


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 ]

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

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

Contacts
Contact: Guillaume JONDEAU, MD,PhD 01 40 25 68 11 guillaume.jondeau@bch.aphp.fr

Locations
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            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Guillaume JONDEAU, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

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

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009