NCT05096143已完成不适用
A Cohort Study to Compare the Hospitalization Between Naive Sacubitril/Valsartan and Naive ACEi/ARBs Heart Failure Patients With Reduced Ejection Fraction Using Secondary US Electronic Health Records Data
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42,269
- 试验地点
- 1
- 主要终点
- Rate of Heart Failure (HF) hospitalizations events for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB Heart Failure with reduced Ejection Fraction (HFrEF) patients
研究概览
简要总结
A non-interventional retrospective cohort study conducted to compare the naive sacubitril/valsartan Heart Failure with reduced Ejection Fraction (HFrEF) patient population to a matched naive ACEi/ARB HFrEF patient population.
详细描述
This was a non-interventional retrospective cohort study using the US secondary EHR dataset, Optum EHR, to compare the naive sacubitril/valsartan HFrEF patient population (aged ≥ 18 years) to a matched naive ACEi/ARB HFrEF patient population.
The study comprised of the following periods:
Identification period: 01-Jul-2015 to 31-Mar-2019
Study period
- 01-Jul-2014 to 31-Mar-2020 for primary objective and secondary objective 2 to 6.
- 01-Jul-2008 to 30-Sep-2020 for secondary objective 1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sacubitril/valsartan incident cohort Included patients
- •Prescribed sacubitril/valsartan within the identification period (01-July-2015 to 31-Mar-2019), that had non-missing gender and year of birth data.
- •With at least one ICD-9-CM or ICD-10-CM code for diagnosis of HF within one-year prior to date of first prescription of sacubitril/valsartan (index date), and are treated as part of the integrated delivery network.
- •With first month active 365 days prior to index and last date active was greater than or equal to (≥) index, and the month of provider source data was greater than the final date of patient follow-up.
- •That were ≥18 years old at index date.
- •With a valid LVEF value ≤40%, prior to index (index date included).
- •Angiotensin-converting enzyme inhibitors (ACEi) and Angiotensin II receptor antagonist (ARB) incident cohort
- •Included patient:
- •Prescribed ACEi or ARBs within the identification period (01-Jul-2015 to 31-Mar-2019), that had non-missing gender and year of birth data.
- •With at least one ICD-9-CM or ICD-10-CM code for diagnosis of HF within one-year prior to date of first prescription of ACEi or ARB (index date), and were treated as part of the integrated delivery network.
- •With first month active 365 days prior to index and last date active was ≥ index, and the month of provider source data is greater than the final date of patient follow-up.
- •That were ≥ 18 years old at index date.
- •With a valid LVEF value ≤ 40%, prior to index (index date included).
排除标准
- •Sacubitril/valsartan incident cohort
- •Excluded patients for the primary objective and secondary objective 2 to 6:
- •Patients who were prescribed sacubitril/valsartan within one-year prior to index date.
- •Patients who were prescribed ACEi or ARBs, within one-year prior to index date (index date included).
- •Exclude patients for secondary objective 1:
- •Patients who were prescribed sacubitril/valsartan prior to index date.
- •Patients who were prescribed ACEi or ARBs prior to index date (index date included).
- •Angiotensin-converting enzyme inhibitors (ACEi) and Angiotensin II receptor antagonist (ARB) incident cohort
- •Exclude patients for the primary objective and secondary objective 2 to 6:
- •Patients who were prescribed ACEi or ARBs within one-year prior to index date.
- •Patients who were prescribed sacubitril/valsartan within one-year prior to index date (index date included).
- •Which had a valid sacubitril/valsartan prescription that enables inclusion in the sacubitril/valsartan cohort.
- •Exclude patients for secondary objective 1:
- •Patients who were prescribed ACEi or ARBs prior to index date.
- •Patients who were prescribed sacubitril/valsartan prior to index date (index date included).
- •Which had a valid sacubitril/valsartan prescription that enables inclusion in the sacubitril/valsartan cohort
研究组 & 干预措施
Naive Sacubitril/valsartan
Participants who were prescribed with Naive Sacubitril/valsartan
干预措施: Sacubitril/valsartan (Drug)
Naive ACEi/ARB
Participants who were prescribed with Naive Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)
干预措施: ACEi/ARB (Drug)
结局指标
主要结局
Rate of Heart Failure (HF) hospitalizations events for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB Heart Failure with reduced Ejection Fraction (HFrEF) patients
时间窗: through study completion, maximum 5 years
Heart failure hospitalizations were defined by ICD-9-CM (The International Classification of Diseases, 9th Revision, Clinical Modification) and ICD-10-CM (International Classification of Diseases, 10th Revision, Clinical Modifier) codes for HF listed within the primary diagnoses associated with a hospitalization that occurred during the follow-up period.
次要结局
- Time to first all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients(through study completion, maximum 5 years)
- Rate of HF hospitalizations events for both Truly naive sacubitril/valsartan HFrEF patients and Truly naive ACEi/ARB HFrEF patients(through study completion, maximum 5 years)
- Time to first HF hospitalization for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients(through study completion, maximum 5 years)
- Rate of HF hospitalizations or Emergency room (ER) visits for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients(through study completion, maximum 5 years)
- Time to first HF hospitalization or HF ER visit for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients(through study completion, maximum 5 years)
- Rate of all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients(through study completion, maximum 5 years)
- Rates of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients(through study completion, maximum 5 years)
研究者
研究点 (1)
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