Study of the Efficacy of Losartan on Aortic Dilatation in Patients With Marfan Syndrome | Clinical Trial - Marfan Sartan

May 15, 2015
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
French Ministry of Health
Date Published:
05/02/2015
Original Posted Date:
05/15/2015
References

Description:

The goal of this trial was to evaluate treatment with losartan compared with placebo among patients with Marfan syndrome.

Contribution to the Literature: The Marfan Sartan trial failed to show that losartan prevented aortic root dilatation.

Study Design

  • Randomized
  • Parallel
  • Blinded

Marfan patients were randomized to losartan (n = 153) versus placebo (n = 150). The dose of losartan was 50 mg for those <50 kg and 100 mg for those ≥50 kg.

Inclusion criteria:

  • Patients at least 10 years of age with Marfan syndrome

Exclusion criteria:

  • Planned or prior aortic root surgery
  • Total number of enrollees: 303
  • Duration of follow-up: Median 3.5 years
  • Mean patient age: 30 years
  • Percentage female: 56%

Principal Findings:

The aortic root diameter increased 0.44 mm/year in the losartan group versus 0.51 mm/year in the placebo group (p = 0.36).

Secondary outcomes:

  • Mean systolic blood pressure was 5 mm Hg lower in the losartan group vs. the placebo group
  • Aortic surgery: 9.9% vs. 8.8%, respectively, for losartan vs. placebo
  • Deaths: 0 vs. 2%, respectively, for losartan vs. placebo

Interpretation:

Among patients with Marfan syndrome, losartan was unable to prevent aortic root dilatation, deaths, or aortic surgery despite a reduction in blood pressure. Beta-blocker therapy remains the standard therapy for Marfan patients.

References:

Milleron O, Arnoult F, Ropers J, et al. Marfan Sartan: a Randomized, Double-Blind, Placebo-Controlled Trial. Eur Heart J 2015;May 2:[Epub ahead of print].

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, Cardiac Surgery and Arrhythmias, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Congenital Heart Disease, CHD and Pediatrics and Arrhythmias, CHD and Pediatrics and Interventions, CHD and Pediatrics and Prevention, CHD and Pediatrics and Quality Improvement, Interventions and Structural Heart Disease

Keywords: Adrenergic beta-Antagonists, Angiotensin II Type 1 Receptor Blockers, Aorta, Blood Pressure, Cardiac Surgical Procedures, Dilatation, Double-Blind Method, Follow-Up Studies, Heart Defects, Congenital, Losartan, Marfan Syndrome, Primary Prevention, Systole


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