Safety and Efficacy Study of Once and Twice Daily Doses of MCC-135 in Subjects With Congestive Heart Failure.
Congestive Heart Failure
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Cardiac Failure, Heart Decompensation, Drug Therapy
Eligibility Criteria
Inclusion: Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study. Having a clinical diagnosis consistent with congestive heart failure, of at least 6 months duration and clinically stable for the last month. Has a left ventricular ejection fraction less than or equal to 40%. Has Plasma b-type (brain) natriuretic peptide levels greater than or equal to 200 pg/ml at screening. Meeting the following requirements for current concomitant medication: Must be using an angiotensin converting enzyme inhibitor or Angiotensin II receptor antagonists therapy for at least 1 month prior to the screening visit. If using beta-blockers, must have commenced treatment at least 4 months prior to the screening visit. All other cardiac medications must have been introduced at least one month prior to the screening visit. Exclusion: Heart failure primarily due to: Obstructive valvular disease Malfunctioning artificial heart valve Congenital heart disease Pericardial disease Uncontrolled thyroid disease Amyloidosis Severe pulmonary disease Restrictive or obstructive cardiomyopathy Known active myocarditis Terminal heart failure or on waiting list for transplant. Atrio-ventricular block except for first-degree atrio-ventricular block. A history of or currently sustained ventricular tachycardia. Subjects with atrial fibrillation and/or requiring pacemakers (including bi-ventricular pacing). Presence of pulmonary embolism. Acute myocardial infarction, unstable angina, coronary revascularization or major surgery during the last 6 weeks prior to screening. Episode of syncope or cardiac arrest during the last 6 weeks prior to screening. Requiring treatment with the following therapies: Anti-arrhythmics (Amiodarone/beta-blockers are permitted) Calcium sensitizers Catecholamines Phosphodiesterase inhibitors Is currently participating in another investigational study or who have participated in an investigational study (including MCC-135) during the 2 months prior to the screening visit Has a history of drug or alcohol abuse, as defined by Diagnostic and Statistical Manual of Mental Disorders-4th edition criteria, within the past two years. Has significant, moderate-severe renal dysfunction or disease, confirmed by serum creatinine of greater than 2mg/dl (180 micromol/L). Serum potassium levels at entry confirmed below 3.5mmol/L. Known severe symptomatic primary pulmonary disease in the last 5 years e.g. asthma, chronic obstructive pulmonary disease. Concurrent severe disease (including significant hepatic, metabolic or other systemic disease) or any medical condition that, in the opinion of the investigator, would compromise the subject's safety or their successful participation in the study. History of multiple drug allergies or with a known allergy to the study drug or any medicine chemically related to the study drug. Individuals who are morbidly obese. Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including: Anti-arrhythmics (Amiodarone/beta-blockers are permitted) Calcium sensitizers Catecholamines Phosphodiesterase inhibitors
Sites / Locations
- Maricopa Medical Center
- University of Arizona Medical Center
- Capitol Intervention Cardiology
- San Diego Cardiovascular
- LAC & USC Medical Center
- ARI Clinical Trials, Inc Arrhythmia Research & Cardiology Health Center
- Clinical Trials Research
- Sacramento Heart & Vascular Medical Associates
- University of California San Diego
- Apex Research Institute
- Cardiology Consultants PA
- Cardiology Associates of Fort Lauderdale
- Jacksonville Center for Clinical Research
- Cardiovascular Center of Sarasota
- Southern Clinical Research & Management
- Medical Group of Fort Wayne, PC
- Medical Center Cardiologist
- Louisville Cardiology Medical Group, PSC
- Louisiana Heart Center
- New Orleans Center for Clinical Research
- Ochsner Clinic
- Cardiac Center of Louisiana, LLC
- Cardiology Associates, PC
- University of Maryland Hospital
- Cardiovascular Consultants, PA
- University of Massachusettes
- University of Michigan
- Henry Ford Health System
- Henry Ford Hospital
- Bryan LGH Heart Institute
- Alegent Health Immanuel Medical Center
- South Jersey Heart Group
- Albert Einstein College of Medicine
- Buffalo General Hospital
- Heart Care Center East
- Hudson Valley Clinical Research
- Saint Vincent Catholic Medical Center
- University of Rochester
- Sterling Research Group
- North Ohio Research, Ltd.
- City Cardiology Associates, Inc.
- Chestnut Hill Cardiology, Ltd.
- University of Pittsburgh Medical Center
- Medical University of South Carolina
- Carolina Research Associates
- The Stern Cardiovascular Center
- Cardiovascular Research Institute of Dallas Medical Center - Cardiologist Research Foundation
- Med-Tech Research
- Tyler Cardiovascular Consultants
- Cardiovascular Associates, Ltd.
- Wisconsin Center for Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
MCC-135 50 mg BID
MCC-135 100 mg QD
MCC-135 200 mg QD
Placebo