The Impact of TORasemide oN hemodynAmic and Neurohormonal Stress, and carDiac remOdeling in Heart Failure - Prospective, Randomized, Open, Blinded Endpoint Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations)
研究概览
简要总结
The aim of the study is to compare the effects of torasemide and furosemide on clinical and biochemical parameters of hemodynamic and neurohormonal compensation and myocardial remodeling in patients with chronic heart failure with indications for use of loop diuretics.
The study protocol 100 patients with heart failure NYHA (New York Heart Association) II-IV (stable or exacerbation aligned cardiopulmonary at the time of enrollment, with a fixed-dose loop diuretics]) treated with optimal medical therapy as clinically indicated for use loop diuretics. Patients will be randomized to treatment with furosemide and torasemide (randomization 1 : 1). After randomization, furosemide will continue in its current fixed-dose or will be replaced by equipotential dose of torasemide (4:1). The minimal follow-up of patients in the study will be at least six months.
详细描述
According to current guidelines, angiotensin converting enzyme inhibitors and beta-adrenolytics are the first-line treatment agents in patients with heart failure. In case of fluid retention, diuretics, as a part of symptomatic treatment, should be administered. In practice, the most common diuretic used in patients with heart failure is loop diuretic - furosemide. What is important, furosemide has no effect on patients' outcomes. Some studies showed unfavourable influence of this drug on rennin-angiotensin-aldosterone system.
Alternative loop diuretic, which may be administered in patients with heart failure is torasemide. Its longer elimination half-life time, similar diuretic effects, lower influence on electrolyte disorders and additional pleiotropic effects could make torasemide more beneficial than furosemide.
Accordingly, only direct comparison of furosemide and torasemide could present similarities and differences of these two agents.
The hypothesis of this study is that torasemide may present more favourable effects on some clinical parameters in patients with heart failure, than furosemide (e.g. clinical symptoms, biochemical parameters, activity of rennin-angiotensin-aldosterone system, side effects).
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
- •heart failure NYHA II-IV
- •previous treatment with diuretics
- •age>18 years
排除标准
- •uncontrolled hypertension
- •uncontrolled diabetes
- •creatinine > 2,5 mg/dl
- •potassium > 6 mg/dl
- •acute coronary syndrome
- •hypertrophic cardiomyopathy
研究组 & 干预措施
Furosemide
This group will receive furosemide as a diuretic treatment
干预措施: Furosemide (Drug)
Torasemide
This group will receive torasemide as a diuretic treatment
干预措施: Torasemide (Drug)
结局指标
主要结局
The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations)
时间窗: up to 12 months
次要结局
- The change of dosing of diuretic due to worsening of condition of patient.(up to 12 months)
- The change of NYHA (New York Heart Association) class - worsening or improvement(up to 12 months)
研究者
Marcin Grabowski
PhD
Medical University of Warsaw