A prospective, observational, multicenter Real-World Evidence study to assess the effectiveness & safety of CIDMUS (sacubitril - valsartan) in Heart Failure with reduced Ejection Fraction (HFrEF) and Heart Failure with mid-range ejection fraction (HFmrEF) patients in India.
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 200
- 试验地点
- 10
- 主要终点
- Change in Ejection Fraction from baseline visit to follow-up visits 1,3,6, and 12 months in Heart failure patients on CIDMUS as per below sub groups
研究概览
简要总结
This is a prospective, observational, multicenter real-world evidence, single-arm study. The study aims to assess the effectiveness and safety of CIDMUS in both HFrEF (EF less than or equal to 40%) and HFmrEF (EF: 41% - 49%) patients, with a total enrollment of 200 subjects at baseline. The study will be carried out in India, across 10 sites in 4-6 cities with subjects who have been prescribed CIDMUS for the first time or within one week. The study comprises subjects who are at least 18 years “ old or above with a 12-month follow-up period. Potential subjects will be screened for eligibility. After meeting the eligibility criteria, the subjects will be enrolled in the study and will be assigned a Unique Identification Number (UIN) to maintain confidentiality. Subjects will be evaluated at Month 1, Month 3, Month 6, and Month 12. Safety will be assessed throughout the study period for 12 months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Male or female patients of Age greater or equal to 18 years 2.Patients diagnosed with Heart Failure with Ejection fraction lessthan 50% at baseline, who were prescribed CIDMUS for the first time or within one week.
- •3.Patients willing to provide consent to participate in the study.
排除标准
- •Contraindications to the study drug as per physician’s discretion.
结局指标
主要结局
Change in Ejection Fraction from baseline visit to follow-up visits 1,3,6, and 12 months in Heart failure patients on CIDMUS as per below sub groups
时间窗: 1,3,6 and 12 months
次要结局
- 1. Safety assessment - Frequency and severity of AEs(2.Emergency visits due to HF requiring inotropic agents/iv diuretics at 1, 3,6, and 12 months)
研究者
Dr Sagar Katare
Dr. Reddy’s Laboratories Limited
