Phase 3
N=40
Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome
Marfan Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00723801 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Aortic Biophysical Properties - Pulse Wave Velocity — -1.15; -0.22 change in meters/second
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Atenolol (Drug); Losartan (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aortic Biophysical Properties - Pulse Wave Velocity |
-1.15; -0.22 | — |
| SECONDARY Diastolic Function - Ejection Fraction |
1.31; 1.57 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age greater than 25 years
- Clinical Marfan Syndrome
Exclusion Criteria
- Previous aortic or cardiac surgery
- Pregnancy
- Renal Insufficiency
- Medication intolerance
Data sourced from ClinicalTrials.gov (NCT00723801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.