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

NCT ID: NCT05096143

Last Updated: 2021-12-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42269 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-03
• Study Completion Date: 2020-10-19

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

Conditions

Heart Failure

Keywords

Heart failure hospitalizations,; sacubitril/valsartan,; Angiotensin II receptor antagonist,; United States,; electronic health record

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Naive Sacubitril/valsartan

Participants who were prescribed with Naive Sacubitril/valsartan

Sacubitril/valsartan

Intervention Type: DRUG

Participants who were prescribed with Sacubitril/valsartan

Naive ACEi/ARB

Participants who were prescribed with Naive Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)

ACEi/ARB

Intervention Type: DRUG

Participants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)

Interventions

Sacubitril/valsartan

Participants who were prescribed with Sacubitril/valsartan

Intervention Type: DRUG

ACEi/ARB

Participants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)

Intervention Type: DRUG

Other Intervention Names

Entresto®

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Novartis Investigative Site

East Hanover, New Jersey, United States

Countries

United States

Related Links

http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17872

Results for CLCZ696B2036 from the Novartis Clinical Trials Website

Other Identifiers

CLCZ696B2036

Identifier Type: -

Identifier Source: org_study_id