Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels - Full Text View

Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels (EXACT-HF)

This study is currently recruiting participants.

Verified February 2011 by Duke University

First Received on September 30, 2009. Last Updated on May 5, 2011 History of Changes

Sponsor:	Duke University
Collaborator:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00987415

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 IV

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:

MedlinePlus related topics: Heart Failure

Drug Information available for: Allopurinol sodium Allopurinol

U.S. FDA Resources

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:	May 2013
Estimated Primary Completion Date:	November 2012 (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: Kerry Lee, PhD

919-668-8725

kerry.lee@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, 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

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Study Chair:	Eugene Braunwald, MD	Harvard University
Study Director:	Alice Mascette, MD	National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator:	Kerry Lee, PhD	Duke University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fravel MA, Ernst ME. Management of gout in the older adult. Am J Geriatr Pharmacother. 2011 Oct;9(5):271-85. Epub 2011 Aug 17.

Responsible Party:	Kerry Lee, PhD, Duke Clinical Research Institute
ClinicalTrials.gov Identifier:	NCT00987415 History of Changes
Other Study ID Numbers:	20011, 5U01HL084904-03
Study First Received:	September 30, 2009
Last Updated:	May 5, 2011
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 February 09, 2012