NCT00987415已完成2 期
Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients
Duke University10 个研究点 分布在 2 个国家目标入组 253 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 253
- 试验地点
- 10
- 主要终点
- A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
allopurinol
Active Comparator
Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
干预措施: allopurinol (Drug)
sugar pill
Placebo Comparator
Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.
干预措施: sugar pill (Drug)
结局指标
主要结局
A Composite Clinical Endpoint (CCE) That Classifies Subject's Clinical Status as Improved, Worsened, or Unchanged.
时间窗: 24 Weeks
CCE composed of 3-level categorical variable with options that include worsened, unchanged or improved
次要结局
- Change in Quality of Life (KCCQ).(Baseline to 12 weeks)
- Change in Submaximal Exercise Capacity (6-MWT)(Baseline to 24 weeks)
- Change in Quality of Life (KCCQ)(Baseline to 24 weeks)
研究者
研究点 (10)
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