Bicuspid Aortic Valve | The Effect of Losartan in Bicuspid Aortic Valve Patients
Bicuspid Aortic Valve research study
What is the primary objective of this study?
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
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Bicuspid Aortic Valve
Thoracic Aortic Aneurysm
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:CozaarAngiotensin II Receptor Blocker
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: September 2011
Completed Date: January 2014
Primary Outcome: Inflammatory Markers Levels
Study sponsors, principal investigator, and references
Principal Investigator: Anna Booher, MD
Lead Sponsor: University of Michigan