The Effect of Losartan in Bicuspid Aortic Valve Patients

Stopped early · Not applicable

Conditions studied: Bicuspid Aortic Valve, Thoracic Aortic Aneurysm

In brief

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

Key facts

Study ID

NCT01390181

Run by

University of Michigan

People needed

4

Starts

2011-09-01

Expected to finish

2014-01-01

Last updated by the study team

2017-04-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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