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NCT00723801 · ClinicalTrials.gov registry record · Phase 3
Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome
A Phase 3 study of Marfan Syndrome, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00723801: Completed Phase 3 study of Marfan Syndrome, sponsored by Brigham and Women's Hospital.
NCT00723801 is a Phase 3 study of Marfan Syndrome that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 40 participants, below the 393-participant average among 4 other Marfan Syndrome trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00723801, a Phase 3 study of Marfan Syndrome, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Aortic stiffness was assessed using applanation tonometry (SphygmoCor®, AtCor Medical, West Ryde, NSW, Sydney, Australia) to measure carotid to femoral artery pulse wave velocity (PWV). With the patient lying supine in a quiet environment, a handheld micromanometer-tipped probe was applied to the skin surface over the carotid and femoral arteries, compressing the vessel wall so that transmural forces within the vessel wall were perpendicular to the arterial surface. The distance from the sternal
Conditions Studied
Interventions
- DRUG Losartan
- DRUG Atenolol
Study Locations (1)
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2007-10 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT00723801 record still lists
NCT00723801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 393-participant average among 4 other Marfan Syndrome trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Marfan Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Losartan is the first listed.
NCT00723801 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00723801 about?
NCT00723801 is a clinical study titled "Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome". 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 pr...
What is the current status of trial NCT00723801?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2007-10. Estimated completion is 2012-12.
What conditions does trial NCT00723801 study?
This clinical trial studies the following conditions: Marfan Syndrome.
What interventions are being tested in trial NCT00723801?
The interventions under investigation include: Losartan (DRUG), Atenolol (DRUG).
Who is sponsoring clinical trial NCT00723801?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00723801 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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