Randomised Control Pilot Trial of n-Acetylcysteine in the Treatment of Chronic Heart Failure With Coexistent Chronic Renal Failure.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Vascular function via non invasive ultrasound measured flow mediated dilatation
研究概览
简要总结
Treatment with n-acetylcysteine in patients with heart failure and chronic renal failure leads to improvements in vascular function and in renal function.
详细描述
Ten patients will be invited to participate in the trial. After obtaining informed consent, the ten patients will be randomly assigned to one month of treatment with oral n-acetylcysteine 500mg or placebo twice daily for thirty days in addition to their regular therapy. At enrolment the patients will be educated and counselled about the trial and the intervention medication. Patients will also have a blood test (serum creatinine) that will allow the calculation of their renal function by use of the Cockroft Gault equation. Blood samples will also be frozen and stored. Patients will also undergo an ultrasound test of the function of their arm blood vessels. Both the blood test and the ultrasound test will be repeated at the completion of the thirty day trial period. Again the blood test sample will be frozen and stored. Subjects will then cross over to the other treatment arm for a further one month period, with the same testing at the end.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 75 years inclusive;
- •Patients with chronic heart failure NYHA II, III and IV and LVEF<40%. Stable medications for 1 month. Not admitted to hospital in the past month.
- •Chronic renal failure with GFR (as estimated by the Cockroft Gault equation) of >30 ml/min and <50 ml/min not on any form of dialysis.
排除标准
- •Age <18 and >75 years;
- •Myocardial infarction in the preceding six months;
- •Acute decompensation of renal function or heart failure in the last 30 days;
- •Allergy to n-acetylcysteine or glyceryl trinitrate;
- •Contraindications to the use of glyceryl trinitrate as per the product information lodged with the PBS (Australia);
- •On treatment with allopurinol, vitamin C or vitamin E or other antioxidant therapy at time of randomisation (statins are acceptable);
- •Acute decompensation of another organ system in the last 30 days;
- •Current pregnancy.
研究组 & 干预措施
1
5 patients: 28 days of n-acetylcysteine (in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to placebo for 28 days after one week washout period.
干预措施: N-acetylcysteine (Drug)
2
28 days of oral distilled water (5ml) (in addition to standard therapy) and then repeat serum creatinine and vascular study then crossover to intervention (N-acetylcysteine 500mg oral bd) for 28 days after one week washout period with tests repeated again at 4 weeks and 9 weeks.
干预措施: N-acetylcysteine (Drug)
结局指标
主要结局
Vascular function via non invasive ultrasound measured flow mediated dilatation
时间窗: baseline, 4 weeks and 9 weeks
Estimated glomerular filtration rate calculated with Cockroft Gault equation.
时间窗: baseline, 4 weeks, 9 weeks
次要结局
- Symptoms of heart failure(baseline, 4 weeks, 9 weeks)
- Death(baseline, 4 weeks, 9 weeks)
- Serum BNP (brain natriuretic peptide)(baseline, 4 weeks, 9 weeks)