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

Primary Purpose

Heart Failure, Elevated Serum Uric Acid

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
allopurinol
sugar pill
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Morehouse School of Medicine
  • Harvard University
  • University of Minnesota
  • Mayo Clinic
  • Duke University Medical Center
  • University Hospitals-Case Medical Center
  • Baylor College of Medicine
  • Univ. of Utah Health Sciences Center
  • University of Vermont
  • University of Montreal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

allopurinol

sugar pill

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Change in Submaximal Exercise Capacity (6-MWT)
6-Minute Walk Test
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.
Change in Submaximal Exercise Capacity (6-MWT)
6-Minute Walk Test

Full Information

First Posted
September 30, 2009
Last Updated
October 28, 2014
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00987415
Brief Title
Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels
Acronym
EXACT-HF
Official Title
Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Elevated Serum Uric Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
allopurinol
Arm Type
Active Comparator
Arm Description
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Intervention Type
Drug
Intervention Name(s)
allopurinol
Intervention Description
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Intervention Type
Drug
Intervention Name(s)
sugar pill
Intervention Description
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
Primary Outcome Measure Information:
Title
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
Description
CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Change in Quality of Life (KCCQ).
Description
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
Title
Change in Submaximal Exercise Capacity (6-MWT)
Description
6-Minute Walk Test
Time Frame
Baseline to 12 weeks
Title
Change in Quality of Life (KCCQ)
Description
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
Title
Change in Submaximal Exercise Capacity (6-MWT)
Description
6-Minute Walk Test
Time Frame
Baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Braunwald, MD
Organizational Affiliation
Harvard University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alice Mascette, MD
Organizational Affiliation
National Heart, Lung, and Blood Institute (NHLBI)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Adrian Hernandez, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morehouse School of Medicine
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Harvard University
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
University Hospitals-Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
Univ. of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
Country
United States
Facility Name
University of Montreal
City
Montreal PQ
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25986447
Citation
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.
Results Reference
derived
PubMed Identifier
21849262
Citation
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.
Results Reference
derived
Links:
URL
http://www.hfnetwork.org
Description
Trial Website

Learn more about this trial

Using Allopurinol to Relieve Symptoms in Patients With Heart Failure and High Uric Acid Levels

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