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].

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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