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

NCT05096143 | Completed

• 1 other identifier: CLCZ696B2036
• Study Type: observational
• Target: 42,269
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  through study completion, maximum 5 years

Secondary Outcomes (7)

• 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

Study Arms (2)

Naive Sacubitril/valsartan

Participants who were prescribed with Naive Sacubitril/valsartan

Drug: Sacubitril/valsartan

Naive ACEi/ARB

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

Drug: ACEi/ARB

Interventions

Sacubitril/valsartan DRUG

Participants who were prescribed with Sacubitril/valsartan

Also known as: Entresto®

Naive Sacubitril/valsartan

ACEi/ARB DRUG

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

Naive ACEi/ARB

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study included heart failure patients with reduced ejection fraction

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936, United States

Location

Related Links

• Results for CLCZ696B2036 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 27, 2021
• Study Start: June 3, 2020
• Primary Completion: October 19, 2020
• Study Completion: October 19, 2020
• Last Updated: December 21, 2021

Record last verified: 2021-12

Locations

US (1)