The Effect of Losartan in Bicuspid Aortic Valve Patients

NCT01390181 | Terminated Results

• 1 other identifier: HUM00048364
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 months

Study Arms (1)

Losartan

EXPERIMENTAL

Drug: Cozaar

Interventions

Cozaar DRUG

Angiotensin II Receptor Blocker

Also known as: Losartan

Losartan

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Bicuspid Aortic Valve Disease; Aortic Aneurysm, Thoracic

Interventions

Losartan

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Aortic Valve Disease; Heart Valve Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Aneurysm; Aneurysm; Vascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Anna Booher
• Organization: Grand Traverse Heart Associates

annabooher3@gmail.com

231 935-5800

Study Officials

• Anna Booher, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: July 8, 2011
• Study Start: September 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Locations

US (1)