The Effect of Losartan in Bicuspid Aortic Valve Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | September 2011 |
| Contact: | Nickole L Carlson, BSN |
| Email: | ngarvey@med.umich.edu |
| Phone: | 734 232 4780 |
The Effect of Losartan Treatment on Matrix Metalloproteinase Levels and Outcomes in Bicuspid Aortic Valve Patients
The specific aims of this study are to:
- Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in
individuals with bicuspid aortic valve and ascending aortic or aortic sinus
measurements >40mm.
- Assess the effect on MMP levels during treatment with losartan, an angiotensin II
receptor blocking agent.
- In the setting of losartan therapy for one year, evaluate the response of MMP levels in
these patients, and clinical outcomes including effects on aortic growth rate
- Establish baseline levels of circulating MMP-2 and -9 , TIMP-1and- 2 and TGFB levels in
individuals with bicuspid aortic valve and ascending aortic or aortic sinus
measurements >40mm.
- Assess the effect on MMP levels during treatment with losartan, an angiotensin II
receptor blocking agent.
- In the setting of losartan therapy for one year, evaluate the response of MMP levels in
these patients, and clinical outcomes including effects on aortic growth rate
Inclusion Criteria:
- Adults >age 18 years and < 65 years old
- Able to give informed consent
- Presence of a bicuspid aortic valve (functional or true bicommisural)and ascending
aorta or sinus of Valsalva >4.0cm
- No contraindications to treatment with Losartan, an Angiotensin II receptor blocker
- Able to safely participate in a 4 week drug washout period if currently taking an
angiotensin II receptor blocker or ACE inhibitor.
Exclusion Criteria:
- Unable to safely take losartan due to one or more of the following:
- Hypersensitivity to losartan or other angiotensin receptor blockers
- Pregnancy
- Nursing mothers
- History of angioedema
- Hypotension - chronically volume depleted patients
- Hepatic or renal impairment (Cr>1.5mg/dL)
- Hyperkalemia (K+>4.8)
- Renal artery stenosis
- Severe congestive heart failure (class III-IV)
- Currently taking potassium supplements or salt substitutes containing potassium
- Currently taking lithium
- Prior surgical intervention to aorta or aortic valve
- Unable or unwilling to give informed consent and follow up with study activities
- Currently taking an angiotensin receptor blocker or ACE inhibitor specifically for
hypertension and are therefore unable to or are unwilling to participate in a 4 week
drug washout period.
- Females of child bearing who are unwilling to practice adequate birth control
throughout the study.
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