Status:
COMPLETED
Effect of Beta-blockers on Structural Remodeling and Gene Expression in the Failing Human Heart
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
GlaxoSmithKline
Conditions:
Idiopathic Dilated Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary goal of the study is to measure in the intact human heart, the alterations in gene expression over time that are associated with reverse remodeling in response to β-blockade. The second go...
Eligibility Criteria
Inclusion
- Idiopathic dilated cardiomyopathy with New York Heart Association Class II-IV symptoms
- No evidence of coronary artery disease by angiography within 2 years of randomization
- If female, patient is (a) surgically sterile or (b) practices an accepted method of birth control and has negative serum pregnancy test
- Patient has been on other conventional cardiac heart failure(CHF) therapy at least 3 weeks prior to baseline assessments (includes angiotensin converting enzyme inhibitors, digoxin, diuretics, and/or vasodilators)
- Patient has left ventricular ejection fraction \< 40% by radionuclide ventriculography within 60 days of randomization
- Patient must demonstrate mental and physical ability and willingness to follow all study-specific instructions
- Patient must voluntarily sign Institutional Review Board (IRB)-approved informed consent form prior to any study-specific procedure
Exclusion
- Patient has heart failure due to or associated with uncorrected primary valvular disease, uncorrected thyroid disease, obstructive/hypertrophic cardiomyopathy, pericardial disease, amyloidosis, active myocarditis, or malfunctioning artificial heart valve.
- Patient is actively on heart transplant list or anticipated to be within 6 months of randomization
- Patient is receiving any of the following medicines:
- Calcium channel blockers
- Theophylline
- Tricyclic antidepressants
- Monoamine oxidase inhibitors
- β-agonists
- β-adrenergic blocking agent (oral)
- Any investigational cardiovascular medication or involvement in another investigational trial
- Flecainide, encainide, propafenone, sotalol, disopyramide, or amiodarone
- Patient has a contraindication to β-blockade (eg asthma)
- Patient has another life-threatening disease with life expectancy \< 2 years due to other illness
- Patient has active hepatic, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease which may adversely affect the safety and efficacy of the study drug or life span of the patient
- Unstable decompensated heart failure (evidence of hypoperfusion, acute pulmonary edema, or hypotension with SBP \< 80 mm Hg)
- Patient is actively abusing ethanol or illicit drugs within 3 months of randomization
- Patient has an automatic implantable cardiac defibrillator that has fired within 3 months of randomization
- Patient has an asymptomatic waking, resting heart rate \< 50 bpm or symptomatic bradycardia \< 60 bpm.
- Patient has uncontrolled insulin-dependent diabetes mellitus with a history of frequent hypoglycemia episodes
- Patient has a high degree atrioventricular block (Mobitz Type II or complete heart block)
- Patient is unable to tolerate magnetic resonance imaging procedures
- Patient has demonstrated non-compliance with previous medical regimens
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01798992
Start Date
September 1 2000
End Date
March 1 2009
Last Update
November 29 2023
Active Locations (2)
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1
University of Colorado Hospital
Denver, Colorado, United States, 80220
2
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132