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Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome

Information source: Brigham and Women's Hospital
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Marfan Syndrome

Intervention: Atenolol (Drug); Losartan (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Brigham and Women's Hospital

Official(s) and/or principal investigator(s):
Mark A Creager, MD, Principal Investigator, Affiliation: Brigham and Women;s Hospital

Overall contact:
Ami B Bhatt, MD, Phone: 617-732-6320

Summary

Marfan syndrome is an inherited connective tissue disorder with morbidity and mortality from aortic dilation and dissection. The degree of aortic dilation and response to beta-blockade (standard of care) vary in adults with Marfan syndrome. However, aortic stiffness is often present, and can be a predictor of aortic dilation and cardiovascular complications. In addition, adults with Marfan syndrome develop left ventricular diastolic dysfunction, which can progress to heart failure. Aortic stiffness and diastolic dysfunction are important and logical therapeutic targets in adults with Marfan syndrome.

TGF-beta mediates disease pathogenesis in Marfan syndrome and contributes to aortic stiffness. The angiotensin receptor blocker, losartan, inhibits TGF-beta activity and reverses aortic wall pathology in a Marfan mouse model. Losartan also decreases aortic stiffness and improves diastolic function in hypertension, renal disease and hypertrophic cardiomyopathy.

This trial is a randomized, double-blind trial of 50 adults with Marfan syndrome, treated with 6 months of atenolol vs. losartan. Arterial tonometry for aortic stiffness and echocardiography for diastolic function will be performed at the beginning and end of treatment. A blood draw for serum markers of extracellular matrix turnover and inflammation will also be performed at 0 and 6 months. We plan to determine whether losartan decreases aortic stiffness and left ventricular diastolic dysfunction significantly more than atenolol.

Clinical Details

Official title: Effects of Losartan vs Atenolol on Aortic Stiffness and Diastolic Function in Adults With Marfan Syndrome

Study design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Aortic biophysical properties

Secondary outcome: Diastolic Function

Detailed description: Please See Summary.

Eligibility

Minimum age: 25 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age greater than 25 years

- Clinical Marfan Syndrome

Exclusion Criteria:

- Previous aortic or cardiac surgery

- Pregnancy

- Renal Insufficiency

- Medication intolerance

Locations and Contacts

Ami B Bhatt, MD, Phone: 617-732-6320

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Ami B Bhatt, MD, Phone: 617-732-6320
Mark A Creager, MD, Principal Investigator
Additional Information

Starting date: October 2007
Last updated: May 3, 2010

Page last updated: October 04, 2010

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