The purpose of this study is to determine whether allopurinol is effective in relieving symptoms of patients with heart failure and high blood uric acid levels.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
253
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Morehouse School of Medicine
Atlanta, Georgia, United States
Harvard University
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved
Time frame: 24 Weeks
Change in Quality of Life (KCCQ).
Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline to 12 weeks
Change in Submaximal Exercise Capacity (6-MWT)
6-Minute Walk Test
Time frame: Baseline to 12 weeks
Change in Quality of Life (KCCQ)
Kansas City Cardiomyopathy (KCCQ) overall summary score - The Kansas City Cardiomyopathy Questionnaire is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Time frame: Baseline to 24 weeks
Change in Submaximal Exercise Capacity (6-MWT)
6-Minute Walk Test
Time frame: Baseline to 24 weeks
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Rochester, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals-Case Medical Center
Cleveland, Ohio, United States
Baylor College of Medicine
Houston, Texas, United States
Univ. of Utah Health Sciences Center
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
University of Montreal
Montreal PQ, Canada