A Study Assessing the Dosage pattern and Demographic characteristics in Heart Failure reduced Ejection Fraction patients initiated with Angiotensin Receptor Neprilysin Inhibitor in India (ADD ARNI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- To assess the dosage pattern and treatment persistence with ARNi therapy in HFrEF patients in India
研究概览
简要总结
This observational study aims to provide insights into the real-world usage patterns of Angiotensin Receptor Neprilysin Inhibitor (ARNi) therapy in patients with Heart Failure with reduced Ejection Fraction (HFrEF) in India. The primary focus is on understanding the dosage patterns and treatment persistence among these patients. Additionally, the study will document the implementation of Guideline-Directed Medical Therapy (GDMT) and assess both the safety and effectiveness of ARNi therapy in this population. The findings will contribute to better clinical decision-making and optimized patient care for HFrEF in the Indian context.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender or aged more than 18 years Patients with documented heart failure with reduced left ventricular ejection fraction less than 40 percent not more than 3 months prior to enrolment Patients with NYHA class II IV and not hospitalized in the past 1 month prior to enrolment ARNi naïve symptomatic, chronic HFrEF patients which includes recently diagnosed patients OR stable chronic HFrEF patients Patients eligible for initiation of ARNi therapy as per the clinical judgement of the treating physician Provide written informed consent.
排除标准
- •Patients who are deemed ineligible for this study at the discretion of the treating physician Pregnant and Lactating female Patients with acute decompensated heart failure Patients with Hyperkalemia potassium level more than or equal to 5.30 mmol per Litres within the past 2 weeks Patients are currently participating in another clinical study.
结局指标
主要结局
To assess the dosage pattern and treatment persistence with ARNi therapy in HFrEF patients in India
时间窗: Baseline and 12 weeks
次要结局
- To describe the medication dosage pattern and the implementation of GDMT in HFrEF patients who are initiated with ARNi(To evaluate the safety of ARNi therapy)
研究者
Dr Sanjay Mittal
Cipla Ltd