Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels
NCT ID: NCT00987415
Last Updated: 2014-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
253 participants
INTERVENTIONAL
2010-05-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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allopurinol
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
allopurinol
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Interventions
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allopurinol
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
sugar pill
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* Left ventricular ejection fraction ≤ 40% by echocardiography- Heart failure symptoms for 3 months despite standard treatment.
* Serum uric acid level ≥ 9.5 mg/dl.
* At least one of the following additional markers of increased risk: Hospitalization, ER visit or urgent clinic visit for heart failure requiring IV diuretics within the previous 12 months; Left ventricular ejection fraction ≤ 25; B-type natriuretic peptide level \> 250 pg/ml
Exclusion Criteria
* Acute coronary syndrome, PCI or CABG within 3 months.
* Current ventricular assist device or ventricular assist device or heart transplant likely within the next 6 months.
* Uncontrolled hypertension (i.e., SBP \> 170 mm Hg or DBP \> 110 mm Hg)
* Serum creatinine \> 3 mg/dL or estimated GFR \< 20 ml/min.
* Evidence of active hepatitis with ALT and AST greater than 3x normal.
* Any condition other than HF which could limit the ability to perform a 6-minute walk test
* Any diseases other than HF which are likely to alter the patient's global perception of status or quality of life over a period of 6 months.
* Receiving treatment with allopurinol currently or within 30 days, or having symptomatic hyperuricemia which requires treatment with allopurinol.
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Eugene Braunwald, MD
Role: STUDY_CHAIR
Harvard University
Alice Mascette, MD
Role: STUDY_DIRECTOR
National Heart, Lung, and Blood Institute (NHLBI)
Adrian Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Morehouse School of Medicine
Atlanta, Georgia, United States
Harvard University
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
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
Countries
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References
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Givertz MM, Anstrom KJ, Redfield MM, Deswal A, Haddad H, Butler J, Tang WH, Dunlap ME, LeWinter MM, Mann DL, Felker GM, O'Connor CM, Goldsmith SR, Ofili EO, Saltzberg MT, Margulies KB, Cappola TP, Konstam MA, Semigran MJ, McNulty SE, Lee KL, Shah MR, Hernandez AF; NHLBI Heart Failure Clinical Research Network. Effects of Xanthine Oxidase Inhibition in Hyperuricemic Heart Failure Patients: The Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients (EXACT-HF) Study. Circulation. 2015 May 19;131(20):1763-71. doi: 10.1161/CIRCULATIONAHA.114.014536. Epub 2015 Apr 14.
Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. doi: 10.1016/j.amjopharm.2011.07.004. Epub 2011 Aug 17.
Related Links
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Trial Website
Other Identifiers
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Pro00020011
Identifier Type: -
Identifier Source: org_study_id
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