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| ID | Type | Description | Link |
|---|---|---|---|
| 5U10HL084904 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allopurinol | Active Comparator | Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks. |
|
| sugar pill | Placebo Comparator | Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allopurinol | Drug | Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Braunwald, MD | Harvard University | Study Chair |
| Alice Mascette, MD | National Heart, Lung, and Blood Institute (NHLBI) | Study Director |
| Adrian Hernandez, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morehouse School of Medicine | Atlanta | Georgia | United States | |||
| Harvard University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25986447 | Derived | 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. | |
| 21849262 |
| Label | URL |
|---|---|
| Trial Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Sugar Pill |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| sugar pill | Drug | Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks. |
|
| Baseline to 12 weeks |
| Change in Submaximal Exercise Capacity (6-MWT) | 6-Minute Walk Test | 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. | Baseline to 24 weeks |
| Change in Submaximal Exercise Capacity (6-MWT) | 6-Minute Walk Test | Baseline to 24 weeks |
| 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 | 44106 | 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 |
| Derived |
| 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. |
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.
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 24 Weeks |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants analyzed included those patients who had complete data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Submaximal Exercise Capacity (6-MWT) | 6-Minute Walk Test | Participants analyzed included those patients who had complete data for this endpoint. | Posted | Mean | Standard Deviation | meters | Baseline to 12 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Participants analyzed included those patients who had complete data for this endpoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Submaximal Exercise Capacity (6-MWT) | 6-Minute Walk Test | Participants analyzed included those patients who had complete data for this endpoint. | Posted | Mean | Standard Deviation | meters | Baseline to 24 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 25 | 128 | 88 | 128 | ||
| EG001 | 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. | 19 | 125 | 64 | 125 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Gastrointestinal Hemorhage | Gastrointestinal disorders |
| |||
| Cellulitis | Infections and infestations |
| |||
| Pneumonia | Infections and infestations |
| |||
| Anticoagulation Drug Level above Therapeutic | Investigations |
| |||
| Gout | Metabolism and nutrition disorders |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Hypertension | Vascular disorders |
| |||
| Pancreatitis | Gastrointestinal disorders |
| |||
| Sepsis | Infections and infestations |
| |||
| Postoperative wound infection | Infections and infestations |
| |||
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders |
| |||
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
| |||
| Diarhea | Gastrointestinal disorders |
| |||
| Gastrointestinal perforation | Gastrointestinal disorders |
| |||
| Device dislocation | General disorders |
| |||
| Atypical pneumonia | Infections and infestations |
| |||
| Wound infection | Infections and infestations |
| |||
| Anticoagulation drug level below therapeutic | Investigations |
| |||
| Diabeties Mellitus inadequate control | Metabolism and nutrition disorders |
| |||
| Epilepsy | Nervous system disorders |
| |||
| Suicidal ideation | Psychiatric disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders |
| |||
| Diarrhea | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Fatigue | General disorders |
| |||
| Non-cardiac chest pain | General disorders |
| |||
| Bronchitis | Infections and infestations |
| |||
| Cellulitis | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Pneumonia | Infections and infestations |
| |||
| Upper respiratory tract infection | Infections and infestations |
| |||
| Urinary tract infection | Infections and infestations |
| |||
| Blood creatinine increased | Investigations |
| |||
| Gout | Metabolism and nutrition disorders |
| |||
| Hyperglycaemia | Metabolism and nutrition disorders |
| |||
| Hyperkalemia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Back pain | Musculoskeletal and connective tissue disorders |
| |||
| Muscle Spasms | Musculoskeletal and connective tissue disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Cough | Respiratory, thoracic and mediastinal disorders |
| |||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Rash | Skin and subcutaneous tissue disorders |
| |||
| Abdominal pain | Gastrointestinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Anstrom | Duke University | 919-668-8902 | kevin.anstrom@dm.duke.edu |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000493 | Allopurinol |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Canada |
|
| Improved |
|
| Participants |
|
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| Participants |
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