2024-519631-42-00招募中4 期
LEVOMEMS: Comparison of the Hemodynamic Profile of Dobutamine and Levosimendan in the Current Therapeutic Context
Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年12月3日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Pulmonary blood pressure measured in mmhg and cardiac output measured in l / min at 3 months
研究概览
简要总结
To assess the change in the pulmonary arterial pressure and the cardiac output with levosimendan or dobutamine
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase 2
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •FEVI <35% for echocardiography in the last 6 months
- •Functional class NYHA> III with functional impairment despite optimized treatment of HF and diuretic with admission or decompensation treated on an outpatient basis with diuretic in the last six months that motivate the implementation of the CardioMEMS device
- •Signing of informed consent
排除标准
- •Creatinine clearance <20 ml / min
- •Presión arterial sistólica <90 mmHg
- •Pregnant or fertile women (who are in the period between menorrhagia and menopause) without effective contraceptive coverage, or in breastfeeding
- •Hypersensitivity to the active ingredients or to any of the excipients
结局指标
主要结局
Pulmonary blood pressure measured in mmhg and cardiac output measured in l / min at 3 months
Pulmonary blood pressure measured in mmhg and cardiac output measured in l / min at 3 months
次要结局
- Renal function parameters:% of glomerular filtrate or creatinine levels (mg / dl), hypotension (systolic blood pressure <100mmHg).
- Adverse events resulting from the administration of the drug
- Combined criteria for death or rehospitalization for heart failure at the beginning and end of each period
- Scores observed in the EuroQoL-5D quality of life test at the beginning and end of each period.
- Scores observed in the 6-minute test at the beginning and end of each period
- CA125, ST2, TnT and NTProBNP levels at the beginning and end of each period.
- Pulmonary congestion parameters by pulmonary ultrasound: B lines
研究者
Andrea Borrellas
Scientific
Instituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol
研究点 (1)
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