Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT01798992
Eligibility 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. β-agonists
6. β-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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01798992
Study Brief:
Protocol Section:
NCT01798992