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Rationale and design of a randomized clinical trial of beta-blocker therapy (atenolol) versus angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome.

Publication ,  Journal Article
Lacro, RV; Dietz, HC; Wruck, LM; Bradley, TJ; Colan, SD; Devereux, RB; Klein, GL; Li, JS; Minich, LL; Paridon, SM; Pearson, GD; Printz, BF ...
Published in: Am Heart J
October 2007

BACKGROUND: Cardiovascular disease, including aortic root dilation, dissection, and rupture, is the leading cause of mortality in patients with Marfan syndrome (MFS). The maximal aortic root diameter at the sinuses of Valsalva is considered the best predictor of adverse cardiovascular outcome. Although advances in therapy have improved life expectancy, affected individuals continue to suffer cardiovascular morbidity and mortality. Recent studies in an FBN1-targeted mouse model of MFS with aortic disease similar to that seen in humans showed that treatment with losartan normalized aortic root growth and aortic wall architecture. METHODS: The Pediatric Heart Network designed a randomized clinical trial to compare aortic root growth and other short-term cardiovascular outcomes in subjects with MFS receiving atenolol or losartan. Individuals 6 months to 25 years of age with a body surface area-adjusted aortic root z score >3.0 will be eligible for inclusion. The primary aim is to compare the effect of atenolol therapy with that of losartan therapy on the rate of aortic root growth over 3 years. Secondary end points include progression of aortic regurgitation; incidence of aortic dissection, aortic root surgery, and death; progression of mitral regurgitation; left ventricular size and function; echocardiographically derived measures of central aortic stiffness; skeletal and somatic growth; and incidence of adverse drug reactions. CONCLUSION: This randomized trial should make a substantial contribution to the management of individuals with MFS and expand our understanding of the mechanisms responsible for the aortic manifestations of this disorder.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

October 2007

Volume

154

Issue

4

Start / End Page

624 / 631

Location

United States

Related Subject Headings

  • Research Design
  • Outcome Assessment, Health Care
  • Marfan Syndrome
  • Losartan
  • Humans
  • Cardiovascular System & Hematology
  • Atenolol
  • Angiotensin II Type 1 Receptor Blockers
  • Adult
  • Adrenergic beta-Antagonists
 

Citation

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Lacro, R. V., Dietz, H. C., Wruck, L. M., Bradley, T. J., Colan, S. D., Devereux, R. B., … Pediatric Heart Network Investigators, . (2007). Rationale and design of a randomized clinical trial of beta-blocker therapy (atenolol) versus angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome. Am Heart J, 154(4), 624–631. https://doi.org/10.1016/j.ahj.2007.06.024
Lacro, Ronald V., Harry C. Dietz, Lisa M. Wruck, Timothy J. Bradley, Steven D. Colan, Richard B. Devereux, Gloria L. Klein, et al. “Rationale and design of a randomized clinical trial of beta-blocker therapy (atenolol) versus angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome.Am Heart J 154, no. 4 (October 2007): 624–31. https://doi.org/10.1016/j.ahj.2007.06.024.
Lacro, Ronald V., et al. “Rationale and design of a randomized clinical trial of beta-blocker therapy (atenolol) versus angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome.Am Heart J, vol. 154, no. 4, Oct. 2007, pp. 624–31. Pubmed, doi:10.1016/j.ahj.2007.06.024.
Lacro RV, Dietz HC, Wruck LM, Bradley TJ, Colan SD, Devereux RB, Klein GL, Li JS, Minich LL, Paridon SM, Pearson GD, Printz BF, Pyeritz RE, Radojewski E, Roman MJ, Saul JP, Stylianou MP, Mahony L, Pediatric Heart Network Investigators. Rationale and design of a randomized clinical trial of beta-blocker therapy (atenolol) versus angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome. Am Heart J. 2007 Oct;154(4):624–631.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

October 2007

Volume

154

Issue

4

Start / End Page

624 / 631

Location

United States

Related Subject Headings

  • Research Design
  • Outcome Assessment, Health Care
  • Marfan Syndrome
  • Losartan
  • Humans
  • Cardiovascular System & Hematology
  • Atenolol
  • Angiotensin II Type 1 Receptor Blockers
  • Adult
  • Adrenergic beta-Antagonists