Retrospective, electronic medical records (EMR) based study to understand usage pattern and effectiveness of sacubitril/valsartan in heart failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 1. To evaluate the usage of sacubitril/valsartan across different
研究概览
简要总结
Real-world, retrospective, multicenter, EMR-based study. Retrospective, electronic medical records (EMR) based study to understand usage pattern and effectiveness of CIDMUS in heart failure.Heart failure Patients prescribed with sacubitril/valsartan and whose ejection fraction (EF) value are available at baseline.The medical records of the patients meeting the eligibility criteria will be taken into consideration. Patient profiling will be done at the baseline.
One follow-up visit (consecutive) post prescription of sacubitril/valsartan will be tracked to assess the effectiveness, tolerability, and dose titration – depending on the availability of the data.
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.Heart failure Patients who have been prescribed with CIDMUS and ejection fraction (EF) value are reported at baseline.
- •2.Patients of either sex ≥18 years of age.
排除标准
- •Patients for whom EF value is not reported at baseline.
结局指标
主要结局
1. To evaluate the usage of sacubitril/valsartan across different
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
reduced EF (HFrEF), HF with moderately reduced EF
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
(HFmrEF), & HF with preserved EF (HFpEF), respectively.
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
2.To understand baseline demographics – patients’ age, gender,
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
body mass index (BMI), systolic blood pressure (SBP),
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
diastolic blood pressure (DBP), comorbid conditions and
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
concomitant medications like beta blocker [BB],
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
mineralocorticoid receptor antagonist [MRA], Sodium-glucose cotransporter-2 [SGLT2] inhibitors and
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
ranges of EF (≤40%, 41-49%, ≥50%) – signifying HF with
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
combinations) as monotherapy and/or combination therapy in
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
HF patients on sacubitril/valsartan.
时间窗: 2017 to 2023 | (Data will be captured for one consecutive follow-up visit from the baseline visit/index | date)
次要结局
- •The effect of CIDMUS on change in EF from baseline(•Change in SBP, & DBP from baseline to follow up visits)