The Effect of Losartan in Bicuspid Aortic Valve Patients

Not Applicable

Terminated

• Conditions: Bicuspid Aortic Valve; Thoracic Aortic Aneurysm
• Interventions: Drug: Cozaar

• Registration Number: NCT01390181
• Lead Sponsor: University of Michigan

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-30
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Study Start: 2011-09
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-03
• Results First Submitted: 2017-03-02
• Results First Submitted QC: 2017-03-02
• Last Update Submitted: 2017-03-02
• Results First Posted: 2017-04-14
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Losartan	Cozaar	-

Primary Outcome Measures

Name	Time	Method
Inflammatory Markers Levels	Baseline and 12 months	Changes in levels of Matrix Metalloproteinase (MMP-2, MMP-9), Tissue Inhibitor of Metalloproteinases (TIMP 1, TIMP 2), \& Transforming Growth Factor-Beta (TGFB) in circulation while taking medication from baseline at 3 months, 6 months and 12 months. The 12 month levels were the primary outcome.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States