Prospective, Randomised, Open, Blinded-endpoint Study of Torasemide Prolonged Release vs Furosemide to Evaluate the Efficacy on Myocardial Fibrosis in Patients With Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 23
- 主要终点
- Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.
研究概览
简要总结
Torasemide is a loop diuretic (pyridine-sulfonylurea)with a wide experience in the treatment of oedema associated to heart failure, kidney or liver disease and either in the treatment of arterial hypertension (alone or combined with other anti-hypertensive drugs). It has been developed a new formulation of Torasemide (Torasemide prolonged release).
The aim of this trial is to study the effects of Torasemide prolonged released in comparison with furosemide, in the reduction of myocardial fibrosis in patients with chronic heart failure (Class II-IV of the New York Heart Association Classification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Aged over 18
- •Patients with chronic heart failure class II-IV (NYHA)due to arterial hypertension
- •Patients clinically stable who required diuretic treatment
- •Patients with left ventricular hypertrophy diagnosed by echocardiogram
- •Patients without ischaemic cardiopathy or non recent disease
- •Signed Informed Consent
排除标准
- •Heart Failure due to aortic stenosis or hypertrophic myocardiopathy
- •Recent coronary syndrome (less than 3 months)
- •Recent myocardial infarction (less than 6 months)
- •Unstable angor pectoris
- •Severe cardiac arrhythmia
- •Pregnancy or breastfeeding
- •Aldosterone antagonists (last 6 months)
- •Current loop diuretic treatment over study doses (torasemide > 10mg/day furosemide > 40 mg/day)
- •known hypersensitivity to study drugs
- •Liver disease (SGPT or AST > twice upper normal limt)
- •Renal impairment (Serum creatinine > 2,5mg/dl)
- •Insulin-dependent diabetes
- •Patient included in another simultaneous study
- •Lactose intolerance
- •Lithium Concomitant treatment
- •Chronic treatment with NSAIDs
- •Concomitant treatment with aminoglycoside antibiotics,etacrynic acid
研究组 & 干预措施
2
Furosemide
干预措施: Furosemide (Drug)
1
Torasemide prolonged released
干预措施: Torasemide Prolonged Release (Drug)
结局指标
主要结局
Myocardial fibrosis reduction:measure of Serum carboxy-terminal peptide of procollagen type 1.
时间窗: 8 months
次要结局
- Clinical improvement (New York Heart Association classification, signs and symptoms of heart failure)(8 months)
- Cardiovascular events(8 months)
- NT-proBNP (Brain Natriuretic Peptide)(8 months)
- Hospitalizations, home care due to cardiovascular causes related to heart failure(8 months)
- Safety and tolerability(8 months)
- Quality of Life (Minnesota Test)(8 months)