Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

The Effect of Losartan in Bicuspid Aortic Valve Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by University of Michigan.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Anna Booher, University of Michigan
ClinicalTrials.gov Identifier:
NCT01390181
First received: June 30, 2011
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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

Condition Intervention
Bicuspid Aortic Valve
Thoracic Aortic Aneurysm
Drug: Cozaar

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Losartan Treatment on Matrix Metalloproteinase Levels and Outcomes in Bicuspid Aortic Valve Patients

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Inflammatory markers level [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 25
Study Start Date: September 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Losartan Drug: Cozaar
Angiotensin II Receptor Blocker
Other Name: Losartan

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390181

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Anna Booher, MD University of Michigan
  More Information

Responsible Party: Anna Booher, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT01390181     History of Changes
Other Study ID Numbers: HUM00048364 
Study First Received: June 30, 2011
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Heart Valve Diseases
Aortic Valve Stenosis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Heart Diseases
Ventricular Outflow Obstruction
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016