de Novo Heart FailureNCT05963282
Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients
An observational study of de Novo Heart Failure, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- de Novo Heart Failure
- How many people
- 9,870 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2021to 19 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- de Novo Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril/valsartan | Prescribed sacubitril/valsartan | |
| ACEi/ARB | Prescribed ACEi or ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of all-cause hospitalizations
Measured: Up to approximately 5 years
Secondary outcomes (10)
Time to first all-cause hospitalization
Measured: Up to approximately 5 years
Number and proportion of HF-specific inpatient hospitalizations
Measured: Up to approximately 5 years
Number and proportion of HF-related inpatient hospitalizations
Measured: Up to approximately 5 years
Number and proportion of cardiovascular (CV)-specific inpatient hospitalizations
Measured: Up to approximately 5 years
Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) all-cause inpatient hospitalizations
Measured: Up to approximately 5 years
Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) HF-specific inpatient hospitalizations.
Measured: Up to approximately 5 years
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
Measured: Up to approximately 5 years
Number and proportion of non-HF inpatient hospitalizations
Measured: Up to approximately 5 years
Number and proportion of non-CV inpatient hospitalizations
Measured: Up to approximately 5 years
Dosages and dose changes of sacubitril/valsartan administered
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start29 Nov 2021
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for de Novo Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 9,870 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963282
- Sponsor's protocol ID
- CLCZ696B2037
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients
- ClinicalTrials.gov ID
- NCT05963282
- Acronym / sponsor ID
- CLCZ696B2037
- Conditions
- de Novo Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,870 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/valsartan | – | –Prescribed sacubitril/valsartan |
| ACEi/ARB | – | –Prescribed ACEi or ARB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (12 listed)
- 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).
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total number of all-cause hospitalizations
Time frame: Up to approximately 5 years
10 secondary outcomes
Time to first all-cause hospitalization
Time frame: Up to approximately 5 years
Number and proportion of HF-specific inpatient hospitalizations
Time frame: Up to approximately 5 years
Number and proportion of HF-related inpatient hospitalizations
Time frame: Up to approximately 5 years
Number and proportion of cardiovascular (CV)-specific inpatient hospitalizations
Time frame: Up to approximately 5 years
Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) all-cause inpatient hospitalizations
Time frame: Up to approximately 5 years
Numbers and proportions of first and recurrent (1st, 2nd, 3rd, 4th and 5th) HF-specific inpatient hospitalizations.
Time frame: Up to approximately 5 years
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
Number and proportion of non-HF inpatient hospitalizations
Time frame: Up to approximately 5 years
Number and proportion of non-CV inpatient hospitalizations
Time frame: Up to approximately 5 years
Dosages and dose changes of sacubitril/valsartan administered
Time frame: Up to approximately 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of de Novo Heart Failure, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of all-cause hospitalizations (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.