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OpenTrials
Completed

NCT Number: NCT05963282

Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Total number of all-cause hospitalizations

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. Time to first all-cause hospitalization

    Time frame: Up to approximately 5 years

  2. Number and proportion of HF-specific inpatient hospitalizations

    Time frame: Up to approximately 5 years

  3. Number and proportion of HF-related inpatient hospitalizations

    Time frame: Up to approximately 5 years

  4. Number and proportion of cardiovascular (CV)-specific inpatient hospitalizations

    Time frame: Up to approximately 5 years

  5. Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) all-cause inpatient hospitalizations

    Time frame: Up to approximately 5 years

  6. Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) HF-specific inpatient hospitalizations.

    Time frame: Up to approximately 5 years

  7. 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

    Time frame: Up to approximately 5 years

  8. Number and proportion of non-HF inpatient hospitalizations

    Time frame: Up to approximately 5 years

  9. Number and proportion of non-CV inpatient hospitalizations

    Time frame: Up to approximately 5 years

  10. Dosages and dose changes of sacubitril/valsartan administered

    Time frame: Up to approximately 5 years

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 27, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.