ChiCTR2100053883招募中Unknown
LevOsimendan to Relieve End-stage heart failure symptoms in Cardiac Resynchronization Therapy non-responders (LORE-CRT) study
Donation from Synmosa Biopharma Corp. and research funds from The University Grants Committee (Hong Kong) Research Matching Grant Scheme1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月30日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- NT-proBNP levels or GDF-15-directed metabolomic shift
研究概览
简要总结
To determine the efficacy of levosimendan in reducing the levels of NT-proBNP, changes in objective measures of frailty and physical function, and in affecting quality of life measures.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- None
入排标准
- 年龄范围
- 65 至 —（—）
- 性别
- All
入选标准
- •Patients meeting all of the following criteria will be eligible for study entry:
- •Aged >= 65 years;
- •NYHA III or IV;
- •CRT non-responder;
- •Left ventricular ejection fraction (LVEF) <40%;
- •Expected survival >=6 months;
- •Not heart transplant candidate;
- •Not ventricular assist device candidate;
- •Able to give informed consent with good mental capacity and competence.
排除标准
- •Patients meeting at least one of the following criteria will be excluded from the study:
- •Active malignancy at the time of study eligibility assessment;
- •Debilitating stroke before the start of the study;
- •Withdrawal by self or family from study;
- •Estimated GFR (calculated by CKD-EPI) < 30 mL/min/1.73m2 at study entry;
- •Complete heart block at study entry;
- •Malignant arrhythmias at study entry;
- •Acute coronary syndrome within 3 months prior to eligibility assessment;
- •Systolic BP < 90 mmHg at study entry;
- •Unoperated hypertrophic obstructive cardiomyopathy or severe aortic stenosis;
- •Hypokalaemia;
- •Severe renal or hepatic impairment.
研究组 & 干预措施
Treatment group
Intermittent infusion of intravenous levosimendan (0.2 μg/kg/min, without loading dose) over 6 hours once every 2 weeks
Standard care group
Standard care with follow-up every 2 weeks
结局指标
主要结局
NT-proBNP levels or GDF-15-directed metabolomic shift
时间窗: Baseline, Week 6, Month 3, Month 6 and Month 9
次要结局
- Cardiac and frailty biomarkers(Baseline, Week 6, Month 3, Month 6 and Month 9)
- Peak oxygen consumption (VO2)(Baseline, Week 6, Month 3, Month 6 and Month 9)
- 6-minute walking distance(Baseline, Week 6, Month 3, Month 6 and Month 9)
- Usual gait speed(Baseline, Week 6, Month 3, Month 6 and Month 9)
- Handgrip strength(Baseline, Week 6, Month 3, Month 6 and Month 9)
- FRAIL scale(Baseline, bi-weekly for first 3 months, monthly from Month 3 onwards)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline, bi-weekly for first 3 months, monthly from Month 3 onwards)
- New York Heart Association(Baseline, bi-weekly for first 3 months, monthly from Month 3 onwards)
- Cardiovascular death
- Hospitalisation for heart failure
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
Levosimendan in Acute Decompensated Heart FailureNCT07262723Chittagong Medical College332
招募中
2 期
Effects of Levosimendan in patients being weaned from venoarterial extracorporal membrane oxygenation. A randomized controlled investigator driven phase II trialCardiogenic Shock2023-508024-36-00Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken, Medical University Of Vienna46
Unknown
4 期
Effect of Levosimendan on miRNAs Regulation in the Failing HeartsHeart FailureNCT04950569Tongji Hospital136
尚未招募
2 期
Efficacy of Unani formulation in heart failureCTRI/2025/01/079662National Institute of Unani Medicine30
尚未招募
不适用
Effect of Roxadustat on Heart Failure Patients With Anaemia and Moderate-to-Severe Chronic Kidney DiseaseHeart FailureAnemiaNCT07268807Zhongda Hospital200