The purpose of this study is to determine the effect of two different doses of MCC-135, once daily (QD) or twice daily (BID), on the disease state and the quality of life in subjects with congestive heart failure.
In recent years the usefulness of angiotensin converting enzyme inhibitors and vasodilators as well as beta-blockers has been realized in the treatment of heart failure. Multi-center studies clinical trials have shown some benefit of angiotensin converting enzyme inhibitors on the morbidity and mortality of heart failure subjects, and physicians are also prescribing angiotensin converting enzyme inhibitors for the initial treatment of subjects with left ventricular dysfunction. Some subjects do not respond to angiotensin converting enzyme inhibitors and intolerance to these compounds has also been observed. Despite the significant reduction in mortality observed in limited controlled studies, the 5-year mortality of subjects with congestive heart failure continues to be high, indicating that there is a significant therapeutic gap in the treatment of this disease. MCC-135 is being studied to assess its usefulness as a supplement or replacement to current treatment and to provide subjects with specific and predictable therapy that will reverse the remodeling of the diseased heart and markedly improve the subject's survival. The current study is an exploratory clinical trial to determine the efficacy of two doses and two dose regimens of MCC-135 when compared to placebo by evaluating improvement in the subject's plasma b-type (brain) natriuretic peptide levels, regular rate (heart rate) variability and clinical signs and symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
204
Change from baseline in the serum levels of brain natriuretic peptide
Time frame: At Final Visit.
Change from baseline in the Minnesota living with heart failure questionnaire score
Time frame: At Final Visit.
Regular rate (heart rate) variability as measured by 24-hour Holter monitoring
Time frame: At Final Visit.
Disease progression status measured by New York Heart Association class
Time frame: At Final Visit.
Disease progression status measured by Global Clinical Status
Time frame: At Final Visit.
Disease progression status measured by Clinical Composite
Time frame: At Final Visit.
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MCC-135 placebo-matching tablets, orally, once daily for up to 12 weeks
Maricopa Medical Center
Phoenix, Arizona, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Capitol Intervention Cardiology
Carmichael, California, United States
San Diego Cardiovascular
Encinitas, California, United States
LAC & USC Medical Center
Los Angeles, California, United States
ARI Clinical Trials, Inc Arrhythmia Research & Cardiology Health Center
Redondo Beach, California, United States
Clinical Trials Research
Roseville, California, United States
Sacramento Heart & Vascular Medical Associates
Sacramento, California, United States
University of California San Diego
San Diego, California, United States
Apex Research Institute
Santa Ana, California, United States
...and 43 more locations