The Effect of Losartan in Bicuspid Aortic Valve Patients

NCT ID: NCT01390181

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-01-31

Brief 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

Conditions

Bicuspid Aortic Valve; Thoracic Aortic Aneurysm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Losartan

Group Type: EXPERIMENTAL

Cozaar

Intervention Type: DRUG

Angiotensin II Receptor Blocker

Interventions

Cozaar

Angiotensin II Receptor Blocker

Intervention Type: DRUG

Other Intervention Names

Losartan

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Anna Booher

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Booher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00048364

Identifier Type: -

Identifier Source: org_study_id