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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: October 19, 2020

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

Interventions

  • Drug: Sacubitril/valsartan
    • Participants who were prescribed with Sacubitril/valsartan
  • Drug: ACEi/ARB
    • Participants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: 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.

Secondary Measures

  • Rate of HF hospitalizations events for both Truly naive sacubitril/valsartan HFrEF patients and Truly naive ACEi/ARB HFrEF patients
    • Time Frame: 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.
  • Time to first HF hospitalization for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
    • Time Frame: 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.
  • Rate of HF hospitalizations or Emergency room (ER) visits for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
    • Time Frame: through study completion, maximum 5 years
    • HF ER visits were defined by ICD-9-CM and ICD-10-CM codes for HF listed within the primary diagnoses associated with ER visits that occurred during the follow-up period.
  • Time to first HF hospitalization or HF ER visit for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
    • Time Frame: through study completion, maximum 5 years
    • HF ER visits were defined by ICD-9-CM and ICD-10-CM codes for HF listed within the primary diagnoses associated with ER visits that occurred during the follow-up period.
  • Rate of all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
    • Time Frame: through study completion, maximum 5 years
    • All-cause hospitalizations were defined as any hospitalization that occurred during the follow-up period.
  • Time to first all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
    • Time Frame: through study completion, maximum 5 years
    • All-cause hospitalizations were defined as any hospitalization that occurred during the follow-up period.
  • Rates of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
    • Time Frame: through study completion, maximum 5 years
    • The rate of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients was reported

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.