The Effect of Losartan in Bicuspid Aortic Valve Patients

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Losartan

Criteria

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.