Open-Label Rollover Study of Levosimendan in Patients With Pulmonary Hypertension With Heart Failure and Preserved Left Ventricular Ejection Fraction (PH-HFpEF)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 18
- 主要终点
- Clinical Safety measured by number of adverse events (AEs )
研究概览
简要总结
PH-HFpEF patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
详细描述
This study will enroll PH-HFpEF patients that have completed a controlled levosimendan study. These patients will receive open-label doses of levosimendan and be periodically evaluated for safety in extended use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Provide a personally signed and dated informed consent document prior to initiation of any study-related procedures that are not considered standard of care.
- •Completed double-blind therapy in a PH-HFpEF clinical study sponsored by Tenax Therapeutics, Inc.
- •May, in the opinion of the Investigator, benefit from continued levosimendan treatment.
- •Female patients of childbearing potential must agree to use a highly effective method of contraception.
- •Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
排除标准
- •Discontinued treatment in the parent study for any reason other than study completion or Sponsor termination of the study.
- •Pregnant or breastfeeding women.
- •Local access to commercially available levosimendan
- •Inability to comply with planned study procedures
- •Patients with scheduled lung or heart transplant or cardiac surgery
- •Dialysis developed since enrollment in parent study (either hemodialysis, peritoneal dialysis, continuous venovenous hemofiltration, or ultrafiltration)
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2
- •Liver dysfunction with Child Pugh Class B or C (see Attachment 2)
- •Evidence of systemic bacterial, systemic fungal, or viral infection refractory to treatment
- •Weight >150kg
- •Systolic blood pressure (SBP) cannot be managed to ensure SBP >100 mmHg at initiation of study drug
- •Heart rate >100 bpm with study drug, persistent for at least 10 minutes at screening.
- •Hemoglobin < 80 g/L
- •Serum potassium < 3.0 mmol/L or > 5.5 mmol/L at baseline that is unresponsive to management
研究组 & 干预措施
Levosimendan Open-Label
Initial: A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion. Ongoing patients are transitioned to daily oral levosimendan (1mg capsules TID)
干预措施: Levosimendan (Drug)
结局指标
主要结局
Clinical Safety measured by number of adverse events (AEs )
时间窗: 2 years
Long-term safety profile of levosimendan measured by number of adverse events (AEs )
Clinical Safety
时间窗: Duration of study (for up to 2 years); Assessed at Weeks 3, 6, 12, 24, and 48 and Follow-Up Visit (termination visit).
Number of Adverse Events per Patient Population
次要结局
- 6-minute walk test (6MWT)(2 years)
- Clinical Events: Death and hospitalizations(2 years)
- Patient global assessment(2 years)
- Physician's Assessment of Functional Class(2 years)