Clinical trial NCT05096143: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure hospitalizations,
sacubitril/valsartan,
Angiotensin II receptor antagonist,
United States,
electronic health record
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-10-27
Enrollment: 42269
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included heart failure patients with reduced ejection fraction

Brief summary: 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.

Detailed description: 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.

Follow-up period: Patients were followed up until 31-Mar-2020, death or patient transfer out.

Baseline period: 365 days prior to index

Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: through study completion, maximum 5 years
Secondary outcomes:
measure: Rate of HF hospitalizations events for both Truly naive sacubitril/valsartan HFrEF patients and Truly naive ACEi/ARB HFrEF patients
timeFrame: through study completion, maximum 5 years
measure: Time to first HF hospitalization for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
timeFrame: through study completion, maximum 5 years
measure: Rate of HF hospitalizations or Emergency room (ER) visits for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
timeFrame: through study completion, maximum 5 years
measure: Time to first HF hospitalization or HF ER visit for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
timeFrame: through study completion, maximum 5 years
measure: Rate of all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
timeFrame: through study completion, maximum 5 years
measure: Time to first all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
timeFrame: through study completion, maximum 5 years
measure: Rates of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
timeFrame: through study completion, maximum 5 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigative Site
state: New Jersey
Study officials:
References: