Effects of Xanthine Oxidase Inhibition on Mechano-Energetic Coupling in Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion
研究概览
简要总结
This study tests the hypothesis that allopurinol, a xanthine oxidase inhibitor, improves heart metabolism in patients with heart failure.
详细描述
Xanthine oxidase have been reported to improve mechano-energetic coupling in failing hearts. The investigators developed a means to directly measure creatine kinase flux, the major energy reserve of the heart, in the human heart exploiting new magnetic resonance technologies.
The investigators propose to study 10 healthy subjects and up to 25 with heart failure (dilated cardiomyopathy) before and after a single 300mg IV infusion of allopurinol.
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
- Double (Participant, Investigator)
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
- •Age > 18 years
- •The patient is willing and able to provide informed consent
- •Clinical diagnosis of chronic heart failure
- •Ejection fraction (EF) < 40% by echocardiography, nuclear multigated acquisition (MUGA) or cath ventriculography
- •No significant coronary disease at cardiac catheterization
- •New York Heart Association (NYHA) Class I-IV symptoms
- •Clinical stabilization for two weeks if following recent congestive heart failure (CHF) decompensation.
排除标准
- •Metallic implant prohibiting magnetic resonance (MR) evaluation
- •Inability to lie flat for MR study
- •Administration of additional investigational drugs
- •Calculated creatinine clearance < 50 mL/min
- •Allergy to allopurinol
- •Current gout flare
- •Currently taking oral allopurinol
研究组 & 干预措施
Allopurinol
One time intravenous administration of Allopurinol 300 mg infused over approximately 20 minutes.
干预措施: Allopurinol (Drug)
Placebo
One time intravenous administration of 50 ml dose of 5% dextrose infused over approximately 20 minutes.
干预措施: Placebo (Drug)
结局指标
主要结局
Myocardial Creatine Kinase (CK) Flux Pre Intravenous Allopurinol Infusion
时间窗: Onset of imaging acquisition.
Magnetic resonance spectroscopy (MRS) Measurement of Myocardial CK Flux Pre Intravenous Allopurinol Infusion
Myocardial CK Flux Post Intravenous Allopurinol Infusion.
时间窗: acute (within 15 minutes of single infusion)
The mean rate of adenosine triphosphate (ATP) flux through the creatine kinase reaction in the heart.
次要结局
- Cardiac PCr/ATP Post Intravenous Infusion(acute (within 15 minutes of single infusion))
- Cardiac PCr/ATP Pre Intravenous Infusion(Onset of image acquisition.)
研究者
Robert G. Weiss
Professor of Medicine and Radiology
Johns Hopkins University