Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels (EXACT-HF)
This study is currently recruiting participants.
Verified August 2012 by Duke University
Sponsor:
Duke University
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00987415
First received: September 30, 2009
Last updated: January 8, 2013
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure Elevated Serum Uric Acid |
Drug: allopurinol Drug: sugar pill |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients |
Resource links provided by NLM:
Further study details as provided by Duke University:
Primary Outcome Measures:
- A composite clinical endpoint (CCE) that classifies subject's clinical status as improved, worsened, or unchanged. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in quality of life (KCCQ). [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
- Change in submaximal exercise capacity (6-MWT) [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: allopurinol |
Drug: allopurinol
Allopurinol300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
| Placebo Comparator: sugar pill |
Drug: sugar pill
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- NYHA class II-IV heart failure due to ischemic or non-ischemic cardiomyopathy.
- 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:
- Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, biopsy-proven myocarditis, severe stenotic valvular disease, or complex congenital heart disease.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987415
Contacts
| Contact: Adrian Hernandez, MD | 919-668-7515 | adrian.hernandez@dm.duke.edu |
Locations
| United States, Georgia | |
| Morehouse School of Medicine | Recruiting |
| Atlanta, Georgia, United States | |
| Contact: Elizabeth Ofili, MD | |
| Principal Investigator: Elizabeth Ofili, MD | |
| United States, Massachusetts | |
| Harvard University | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Lynne Stevenson, MD | |
| Principal Investigator: Lynne Stevenson, MD | |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States | |
| Contact: Steven Goldsmith, MD | |
| Principal Investigator: Steven Goldsmith, MD | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States | |
| Contact: Margaret Redfield, MD | |
| Principal Investigator: Margaret Redfield, MD | |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States | |
| Contact: Christopher O'Conner, MD | |
| Principal Investigator: Christopher O'Conner, MD | |
| United States, Ohio | |
| University Hospitals-Case Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Principal Investigator: James Fang, MD | |
| United States, Texas | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States | |
| Contact: Anita Deswal, MD | |
| Principal Investigator: Anita Deswal, MD | |
| United States, Utah | |
| Univ. of Utah Health Sciences Center | Recruiting |
| Salt Lake City, Utah, United States | |
| Contact: David Bull, MD | |
| Principal Investigator: David Bull, MD | |
| United States, Vermont | |
| University of Vermont | Recruiting |
| Burlington, Vermont, United States | |
| Contact: Martin LeWinter, MD | |
| Principal Investigator: Martin LeWinter, MD | |
| Canada | |
| University of Montreal | Recruiting |
| Montreal PQ, Canada | |
| Contact: Jean-Lucien Rouleau, MD | |
| Principal Investigator: Jean-Lucien Rouleau, MD | |
Sponsors and Collaborators
Duke University
Investigators
| Study Chair: | Eugene Braunwald, MD | Harvard University |
| Study Director: | Alice Mascette, MD | National Heart, Lung, and Blood Institute (NHLBI) |
| Principal Investigator: | Adrian Hernandez, MD | Duke University |
More Information
Additional Information:
No publications provided by Duke University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00987415 History of Changes |
| Other Study ID Numbers: | Pro00020011, 5U01HL084904-03 |
| Study First Received: | September 30, 2009 |
| Last Updated: | January 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Allopurinol Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants |
Antirheumatic Agents Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013