Levosimendan In Ambulatory Heart Failure Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 70
- 试验地点
- 14
- 主要终点
- the number of deaths
研究概览
简要总结
The objective of the study is to determine the efficacy of repeated infusions of levosimendan in the group of outpatients with advanced systolic heart failure (HF).
详细描述
It is a multicentre, randomized, double-blind, placebo-controlled study. 350 subjects will be included (in 12 or more medical centers) with severe HF, ejection fraction ≤35%, in New York Heart Association class III or IV. The other inclusion criteria concern: hospitalization for the HF decompensation in the last 3 months and a reduced six-minute walk test <350m or elevated NTproBNP ≥1000 pg / mL. To the European Society of Cardiology-guided, individually optimized medical therapy (OMT) the investigational product (IP) will be added. The subjects will be randomly assigned to one of the study group: 175 to the levosimendan arm and 175 to the placebo arm. The intervention studied in LEIA-HF trial is the administration of levosimendan as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total). All study participants will also continue OMT. In the second phase of the study, after completing the levosimendan / placebo infusions, another 6 visits are planned, still double-blind, every 4 weeks, to assess the safety of treatment discontinuation (with optional return to the infusions by the Investigator when additional criteria for HF decompensation are met).
The efficacy of the treatment will be assessed after 52 weeks, 4 weeks after the last levosimendan / placebo administration.
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
- Triple (Participant, Care Provider, 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
- •Informed consent obtained before any trial activities
- •Male or female, age ≥ 18 years at the time of signing informed consent
- •Left ventricle ejection fraction ≤ 35%
- •Hospitalization due to worsening of HF within the last 3 months
- •New York Heart Association functional class III or outpatient IV
- •Individually optimized pharmacotherapy, based on the current European Society of Cardiology recommendations, stable for at least 1 month prior to randomization, according to the knowledge and experience of the qualifying clinician
- •Distance covered in six-minute walk test <350m OR NTproBNP concentration ≥ 1000 pg/mL
- •In the opinion of the Investigator, the patient does not currently require hospitalization
- •Patient protected with an implantable device capable of terminating life-threatening arrhythmias and conduction disturbances (ICD or cardiac resynchronisation therapy-D/P), if indicated and the patient consents to implantation.
排除标准
- •Known or suspected hypersensitivity to trial products or related products,
- •Restrictive or hypertrophic cardiomyopathy, uncorrected severe valvular disease, potentially reversible cause of HF
- •Hypotension with symptoms of tissue hypoperfusion
- •Uncontrolled hypertension
- •Planned revascularization or other surgical treatment of HF within the next year
- •Advanced chronic kidney disease
- •Features of liver damage
- •Severe chronic lung disease with features of respiratory distress or severe abnormal spirometry or home oxygen treatment
- •Accompanying chronic diseases with poor prognosis
- •Paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia, torsade de pointes, advanced atrioventricular blocks within one month prior to screening
- •Receipt of any investigational product within 30 days before screening visit
- •Any disorder, which in the investigator's opinion may jeopardise subject's safety or compliance with the study protocol and procedures
研究组 & 干预措施
Levosimendan
administration of levosimendan
干预措施: Levosimendan (Drug)
Placebo
administration of placebo
干预措施: Placebo (Other)
结局指标
主要结局
the number of deaths
时间窗: 12 months of follow-up period
death for any cause
the number of unplanned hospitalization
时间窗: 12 months of follow-up period
unplanned hospitalization due to heart failure decompensation
次要结局
- total mortality calculations(0-12, 12-18 and 0-18 months)
- cardiovascular mortality calculations(0-12, 12-18 and 0-18 months)
- the number of planned hospitalization(0-12, 12-18 and 0-18 months)
- the number of implantations of mechanical circulatory support(0-12, 12-18 and 0-18 months)
- the number of heart transplantations(0-12, 12-18 and 0-18 months)
- quality of life measurements(0-12, 12-18 and 0-18 months)
- the six-minute walk test(0-12, 12-18 and 0-18 months)
- NTproBNP measurements(0-12, 12-18 and 0-18 months)
- estimated glomerular filtration rate measurements(0-12, 12-18 and 0-18 months)
- echocardiographic parameters(0-12, 12-18 and 0-18 months)
- patients who returned to levosimendan / placebo infusions(from the 12th to the 18th months of the study)