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The Effect of Losartan in Bicuspid Aortic Valve Patients

Primary Purpose

Bicuspid Aortic Valve, Thoracic Aortic Aneurysm

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cozaar
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bicuspid Aortic Valve

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Losartan

Arm Description

Outcomes

Primary Outcome Measures

Inflammatory Markers Levels
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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2011
Last Updated
March 2, 2017
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT01390181
Brief Title
The Effect of Losartan in Bicuspid Aortic Valve Patients
Official Title
The Effect of Losartan Treatment on Matrix Metalloproteinase Levels and Outcomes in Bicuspid Aortic Valve Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Due to low enrollment the decision was made to terminate study prior to final data collection for any individual.
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bicuspid Aortic Valve, Thoracic Aortic Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Losartan
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cozaar
Other Intervention Name(s)
Losartan
Intervention Description
Angiotensin II Receptor Blocker
Primary Outcome Measure Information:
Title
Inflammatory Markers Levels
Description
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.
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Booher, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

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The Effect of Losartan in Bicuspid Aortic Valve Patients

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