NCT03437226Unknown3 期
Repetitive Levosimendan Infusion for Patients With Advanced Chronic Heart Failure
Dr. Gerhard Pölzl1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2018年3月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Time to death, high-urgent heart transplantation or ventricular assist device (VAD), time to non-fatal HF event
研究概览
简要总结
Repetitive levosimendan infusions for patients with advanced chronic heart failure (LeoDOR) A randomised, double-blind, placebo-controlled multicentre study with parallel group design.
Mortality and rehospitalisation rates are high in the vulnerable phase following heart failure hospitalisation. Previous studies suggest that these events can be reduced by repeat infusions of levosimendan in patients with advanced heart failure.
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
- •Written, signed and dated informed consent.
- •Male and female patients over 18 years of age.
- •Women of childbearing potential must have a monthly negative pregnancy test and must refrain from breastfeeding. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be of childbearing potential.
- •CHF diagnosed at least 6 months before screening and treated with individually optimised long-term oral treatment for the last month, unless not tolerated (e.g., ACE-inhibitor or AT II blocker, beta-blocker, mineralocorticoid receptor antagonist, angiotensin II receptor blocker neprilysin inhibitor [ARNI] and with devices [e.g., CRT/ICD], as needed).
- •Left ventricular ejection fraction less than or equal to 30% as assessed by echocardiography, radionuclide ventriculography or contrast angiography within the index hospitalisation.
- •Currently hospitalised for decompensated HF requiring i.v. diuretics, or i.v. vasodilators, or i.v. inotropic therapy, or their combination.
- •Previous hospitalisation or visit to outpatient clinic requiring i.v. diuretics, i.v. vasodilators, or i.v. inotropic therapy, or their combination for acute decompensated HF within 12 months before the current hospitalisation.
- •NT-proBNP level after recompensation of more or equal 2500 ng/L (BNP more or equal 900 ng/L) and/or NYHA class III or IV at study entry
排除标准
- •Severe obstruction of ventricular outflow tracts such as haemodynamically significant uncorrected primary valve disease or hypertrophic cardiomyopathy or impaired ventricular filling such as restrictive cardiomyopathy.
- •Predominantly right heart failure a/o severe tricuspid regurgitation
- •Cardiac surgery or coronary angioplasty within 30 days before study drug initiation.
- •Acute coronary syndrome within 30 days before study drug initiation.
- •Patients who are scheduled for cardiac surgery or angioplasty in the next 3 months
- •History of torsades de pointes
- •Stroke or transient ischaemic attack (TIA) within 3 months before study drug initiation
- •Systolic blood pressure less than 90 mmHg at baseline
- •Heart rate 120 bpm or greater at baseline
- •Serum potassium less than 3.5 mmol/l before study drug initiation.
- •Severe renal insufficiency (estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2)
- •Anaemia (haemoglobin < 10 g/dl)
- •Significant hepatic impairment at the discretion of the investigator.
- •Hypersensitivity to levosimendan
- •Other serious diseases limiting life expectancy considerably (e.g. end-stage cancer, end-stage lung disease)
- •Participation in a clinical trial with any experimental treatment within 30 days prior to screening or previous participation in the present study
- •Administration of levosimendan within 14 days prior the study drug initiation, the first study drug application has to be postponed for at least 14 days after the end of this premedication
- •Suspected non-compliance
- •Pregnant woman and nursing mother
- •Failure to use highly-effective (Pearl Index lower than 1%) contraceptive methods.
- •Person with any kind of dependency on the investigator
- •Person held in an institution by legal or official order
研究组 & 干预措施
Levosimendan Arm
Experimental
Patients receive 6 or 24 hours infusion depending on the site. Levosimendan 2.5 MG/M 6h infusion group: 0,2 μg/kg/min 7 times (day 0, 14, 28, 42, 56, 70, 84) Levosimendan 24h infusion group: 0,1 μg/kg/min 5 times (day 0, 21,42,63,84) Levosimendan
干预措施: Levosimendan 2.5 MG/ML (Drug)
Placebo Arm
Placebo Comparator
Patients receive 6 or 24 hours infusion depending on the site. 6h infusion group: 0,2 μg/kg/min 7 times (day 0, 14, 28, 42, 56, 70, 84) Placebo 24h infusion group: 0,1 μg/kg/min 5 times (day 0, 21,42,63,84) Placebo
干预措施: Placebos (Drug)
结局指标
主要结局
Time to death, high-urgent heart transplantation or ventricular assist device (VAD), time to non-fatal HF event
时间窗: From baseline (day 1) up to Follow-up 2 (day 180)
Time to event in days, from baseline visit (day 1) up to Follow-up 2 (day 180)
Change in NT-proBNP
时间窗: Change from Baseline NT-proBNP (day 1) to Follow-up 1 (day 90)
pg/ml
次要结局
- Change in functional status and symptoms via EQ-5D-5L (Combined Outcome measurement)(From baseline (day 1) up to day 98 (FUP 1))
- cumulative number of: days alive out of hospital (Combined Outcome measurement)(From baseline (day 1) up to day 180 (FUP 2))
- cumulative number of: non-fatal HF events (Combined Outcome measurement)(From baseline (day 1) up to day 180 (FUP 2))
- cumulative number of: hospital admissions (Combined Outcome measurement)(From baseline (day 1) up to day 180 (FUP 2))
- death(From baseline (day 1) to day 180 (FUP 2))
- Change in functional status and symptoms via KCCQ (Combined Outcome measurement)(From baseline (day 1) up to day 98 (FUP 1))
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)(From baseline (day 1) to day 180 (FUP 2))
- Change in functional status and symptoms via PGA (Combined Outcome measurement)(From baseline (day 1) up to day 98 (FUP 1))
研究者
Dr. Gerhard Pölzl
Univ. Prof. Dr. med.
Medical University Innsbruck
研究点 (1)
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