Clinical trial NCT05963282: Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients
Official title: Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: de Novo Heart Failure
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-07-27
Enrollment: 9870
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

Brief summary: This was a non-interventional retrospective cohort study of de novo heart failure with reduced ejection fraction (HFrEF) patients (aged ≥18 years) commencing first-line treatment on either sacubitril/valsartan or commencing or continuing angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blocker (ARB) therapy for HF in the United States (US) using the secondary source of data, Optum Electronic Health Records (EHR).


Eligibility criteria: Inclusion Criteria:

Sacubitril/valsartan cohort:

* Prescribed sacubitril/valsartan within the identification period.
* With at least one International Classification of Diseases, 9th Revision (ICD)-9 or 10th Revision (ICD-10) code for diagnosis of HF within 30 days prior to the index date (including index date), that had non-missing sex and year of birth data.
* Active in the database for 759 days prior to index.
* With left ventricular ejection fraction (LVEF) ≤ 40% known prior to index day (including index date).
* That were treated as part of the integrated delivery network (IDN).

ACEi/ARB cohort:

* Prescribed ACEi or ARB within the identification period.
* With at least one ICD-9 or ICD-10 code for diagnosis of HF within 30 days prior to the index date (including index date), that have non-missing sex and year of birth data.
* Active in the database for 759 days prior to index.
* With LVEF ≤ 40% known prior to index day (including index date).
* That were treated as part of the IDN.

Exclusion Criteria

Sacubitril/valsartan cohort:

* That were \< 18 years old at index date.
* That were prescribed sacubitril/valsartan within the baseline period or identification period (whichever was earlier) at any time prior to the index date (excluding).
* With one or more ICD-9 or ICD-10 codes for diagnosis of HF within the baseline period, excluding the 30 days prior to index in which HF was initially identified (patient should have had no prior history of HF).
* That were prescribed ACEi/ARB \> 2 days before index date, and within 30 days after a HF diagnosis during the identification period (i.e. any patient included in the ACEi/ARB cohort with an earlier index date, regardless of whether LVEF was ≤ 40% or \> 40%)
* With LVEF ≤ 10% as the closest value to index date (including).

ACEi/ARB cohort:

* That were \< 18 years old at index date.
* That were prescribed sacubitril/valsartan within the baseline period or identification period (whichever was earlier) at any time prior to the index date, on the index date, or until ≤ 2 days after the index date.
* With one or more ICD-9 or ICD-10 codes for diagnosis of HF within the baseline period, excluding the 30 days prior to index in which HF was initially identified (patient should have had no prior history of HF).
* With LVEF ≤ 10% as the closest value to index date (including).

Primary outcomes:
measure: Total number of all-cause hospitalizations
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Time to first all-cause hospitalization
timeFrame: Up to approximately 5 years
measure: Number and proportion of HF-specific inpatient hospitalizations
timeFrame: Up to approximately 5 years
measure: Number and proportion of HF-related inpatient hospitalizations
timeFrame: Up to approximately 5 years
measure: Number and proportion of cardiovascular (CV)-specific inpatient hospitalizations
timeFrame: Up to approximately 5 years
measure: Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) all-cause inpatient hospitalizations
timeFrame: Up to approximately 5 years
measure: Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) HF-specific inpatient hospitalizations.
timeFrame: Up to approximately 5 years
measure: Number and proportion of patients with ≥1 implantable cardioverter defibrillator (ICD) insertion during a hospitalization or during an emergency room (ER) visit for both the sacubitril/valsartan and ACEi/ARB cohorts
timeFrame: Up to approximately 5 years
measure: Number and proportion of non-HF inpatient hospitalizations
timeFrame: Up to approximately 5 years
measure: Number and proportion of non-CV inpatient hospitalizations
timeFrame: Up to approximately 5 years
measure: Dosages and dose changes of sacubitril/valsartan administered
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: