The Effect of Losartan in Bicuspid Aortic Valve Patients

Thoracic Aortic Aneurysm Clinical Trial

Official title:

The Effect of Losartan Treatment on Matrix Metalloproteinase Levels and Outcomes in Bicuspid Aortic Valve Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01390181
• Other study ID #: HUM00048364
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2011
• Last updated: January 3, 2013
• Start date: September 2011

Study information

• Verified date: January 2013
• Source: University of Michigan
• Contact: Nickole L Carlson, BSN
• Phone: 734 232 4780
• Email: ngarvey[@]med.umich.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Bicuspid Aortic Valve
• Heart Valve Diseases
• Thoracic Aortic Aneurysm

Intervention

Drug:
• Cozaar
Angiotensin II Receptor Blocker

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory markers level	Record changes in levels of MMP-2, MMP-9, TIMP 1, TIMP 2, & TGFB in circulation while taking medication from baseline at 3 months, 6 months and 12 months.	Baseline and 12 months	No