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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01798992
Date of registration: 22/02/2013
Prospective Registration: No
Primary sponsor: University of Colorado, Denver
Public title: Effect of Beta-blockers on Structural Remodeling and Gene Expression in the Failing Human Heart BORG
Scientific title: Beta-blocker Effect on Structural Remodeling and Gene Expression in the Failing Human Heart
Date of first enrolment: September 2000
Target sample size: 56
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01798992
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Michael R Bristow, MD PhD
Address: 
Telephone:
Email:
Affiliation:  University of Colorado School of Medicine
Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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:

1. Calcium channel blockers

2. Theophylline

3. Tricyclic antidepressants

4. Monoamine oxidase inhibitors

5. ß-agonists

6. ß-adrenergic blocking agent (oral)

7. Any investigational cardiovascular medication or involvement in another
investigational trial

8. Flecainide, encainide, propafenone, sotalol, disopyramide, or amiodarone

- Patient has a contraindication to ß-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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Idiopathic Dilated Cardiomyopathy
Intervention(s)
Drug: Carvedilol
Drug: Metoprolol succinate
Drug: Metoprolol succinate + doxazosin
Primary Outcome(s)
Improvement in Left Ventricular Ejection Fraction (LVEF) at 12 Months [Time Frame: 12 months]
Secondary Outcome(s)
Composite of All-cause Mortality, Need for Heart Transplant or Need for Ventricular Assist Device. [Time Frame: 18 months]
Improvement in LVEF at 3 Months [Time Frame: 3 months]
Secondary ID(s)
00-0242
2R01HL048013
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
AstraZeneca
GlaxoSmithKline
National Heart, Lung, and Blood Institute (NHLBI)
Ethics review
Results
Results available: Yes
Date Posted: 20/02/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01798992
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