Molecular Mechanisms of Volume Overload-Aim 1(SCCOR in Cardiac Dysfunction and Disease)
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Mitral Regurgitation
In brief
The investigators hypothesize that beta-1 receptor blockade (ß1-RB) attenuates extracellular matrix (ECM) degradation and progressive adverse Left Ventricular (LV) remodeling and failure in the volume overload of mitral regurgitation (MR). Patients without coronary artery disease and moderate MR, as assessed by color/flow Doppler echocardiography, will be randomized to ß1-RB vs. placebo to address the following aims: \*Aim 1: Establish whether ß1-RB attenuates adverse LV remodeling compared to placebo in patients with non-surgical, chronic MR. Using 3-dimensional magnetic resonance imaging (MRI) and tissue tagging, LV function and geometry will be assessed at baseline and every 6 months for up to 2 years. Aim 2: Determine whether indices of inflammation correlate with degree of LV remodeling and whether ß1-RB decrease indices of inflammation and collagen turnover. At the time of MRI, blood samples for collagen breakdown products, matrix metalloproteinase (MMP) activity, and markers of excess production of reactive inflammatory species (RIS) will be obtained and related to changes in LV remodeling defined by serial 3-dimensional MRI and tissue tagging.
Key facts
- Study ID
- NCT01052428
- Run by
- University of Alabama at Birmingham
- People needed
- 38
- Starts
- 2004-08-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2012-11-22
Who can join
Age: 19 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Significant obstructive coronary artery disease and/or myocardial ischemia on graded exercise test with myocardial perfusion.
- Previous myocardial infarction or percutaneous coronary intervention.
- Hypertrophic cardiomyopathy, congenital or pericardial disease.
- Aortic valve disease (> trace aortic regurgitation or mean gradient > 10 mmHg).
- Mitral stenosis (mean gradient >5 mmHg, valve area < 1.5 cm2).
- Intolerance or contraindication to Beta1-AR blockade.
- Renal failure with creatinine > 2.5 mg/dl.
- Hypertension requiring medical treatment or renal artery stenosis.
- Severe comorbidity: liver disease, malignancy, collagen vascular, steroid requirement.
- Pregnancy (negative pregnancy test and effective contraceptive methods are required prior to enrollment of females of childbearing potential).
- Uncontrolled (rate > 120/min) or recent (<4 weeks) atrial fibrillation.
- Routine, regular use of anti-inflammatory medications.
- Exclusion Criteria Related to MRI
- Severe claustrophobia.
- Presence of a pacemaker or non-removable hearing aid.
- Presence of metal clips in the body.
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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