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

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05096143
• Other study ID #: CLCZ696B2036
• Status: Completed
• Start date: June 3, 2020
• Est. completion date: October 19, 2020

Study information

• Verified date: December 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42269
• Est. completion date: October 19, 2020
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
United States	Novartis Investigative Site	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of HF hospitalizations events for both Truly naive sacubitril/valsartan HFrEF patients and Truly naive ACEi/ARB 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	Time to first HF hospitalization for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB 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	Rate of HF hospitalizations or Emergency room (ER) visits for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients	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.	through study completion, maximum 5 years
Secondary	Time to first HF hospitalization or HF ER visit for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients	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.	through study completion, maximum 5 years
Secondary	Rate of all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients	All-cause hospitalizations were defined as any hospitalization that occurred during the follow-up period.	through study completion, maximum 5 years
Secondary	Time to first all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients	All-cause hospitalizations were defined as any hospitalization that occurred during the follow-up period.	through study completion, maximum 5 years
Secondary	Rates of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients	The rate of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients was reported	through study completion, maximum 5 years

External Links

•   Results for CLCZ696B2036 from the Novartis Clinical Trials Website