Heart FailureNCT07376265
A Real-world Study to Compare the Effectiveness of Sacubitril/Valsartan Versus ACEi/ARB in HFrEF Patients
An observational study of Heart Failure, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective, observational, comparative cohort study using secondary data from electronic health records (EHR) from a local health unit that provides primary, secondary and tertiary care to a resident population in northern Portugal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 1,249 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 11 Apr 2024
- 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: The study included heart failure patients with reduced ejection fraction.
Who may be able to join
- Left ventricular ejection fraction (LVEF) < 40%
- Brain natriuretic peptide (BNP) ≥35 pg/mL or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥125 pg/mL
- Had a record in the database in the 365 days prior to the index date
Who cannot join
- Missing sex or date of birth
- Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2 at SAC/VAL, ACEi or ARB initiation
- History of angioedema or unacceptable side effects during receipt of SAC/VAL, ACEi or ARB
- Severe hepatic impairment, biliary cirrhosis, and cholestasis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of Sacubitril/Valsartan vs ACEi/ARB in HFrEF Patients: Real Heart PT
This was a retrospective, observational, comparative cohort study using secondary data from electronic health records (EHR) from a local health unit that provides primary, secondary and tertiary care to a resident population in northern Portugal. The study aimed to assess the comparative effectiveness of sacubitril/valsartan (SAC/VAL) versus angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) in patients with heart failure with reduced ejection fraction (HFrEF).
- Conditions
- Heart Failure
- Keywords
- Sacubritril-valsartan, Heart failure, Cardiovascular outcomes
- Medical subject headings
- 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 |
|---|---|---|
| SAC/VAL Cohort | Adult patients with HFrEF undergoing therapy with SAC/VAL. | |
| ACEi/ARB Cohort | Adult patients with HFrEF undergoing therapy with ACEi/ARB. | |
| Missed Opportunities Cohort | Patients who were eligible for but did not receive SAC/VAL. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hazard Ratio for the Composite of Cardiovascular Death or Heart Failure Hospitalization
Measured: 180 days, 810 days, 1260 days
Secondary outcomes (20)
Hazard Ratio for Death From Cardiovascular Causes
Measured: 180 days, 810 days, 1260 days
Hazard Ratio for Hospitalization for Heart Failure
Measured: 180 days, 810 days, 1260 days
Hazard Ratio for First Hospitalization or Emergency Room Visit
Hospitalizations or emergency room visits for heart failure, and any cause were recorded.
Measured: 180 days, 810 days, 1260 days
Hazard Ratio for First Cardiovascular-specific Hospitalization
Measured: 180 days, 810 days, 1260 days
Hazard Ratio for the Composite of Death From Cardiovascular Causes, Hospitalization for Heart Failure, Non-fatal Myocardial Infarction and Non-fatal Stroke
Measured: 180 days, 810 days, 1260 days
Hazard Ratio for Implantable Cardioverter-defibrillator (ICD) Procedure
Measured: 180 days, 810 days, 1260 days
Hazard Ratio for All-cause Mortality
Measured: 180 days, 810 days, 1260 days
Hazard Ratio for Improved LVEF
Improved LVEF was defined as having at least one LVEF measurement equal or above 40% after having an LVEF under 40%.
Measured: 180 days, 810 days, 1260 days
Pearson Correlation Coefficient Between Change From Baseline in NT-proBNP and LVEF
Measured: 180 days, 810 days, 1260 days
Change From Baseline in NT-proBNP
Measured: 180 days, 810 days, 1260 days
Change From Baseline in LVEF
Measured: 180 days, 810 days, 1260 days
Total Healthcare Resource Utilization Costs per Calendar Year
Healthcare utilization costs included costs for inpatient care, outpatient care, medication, and exams.
Measured: Up to 5 years
Number of Days Patients Were Absent From Work per Calendar Year
Measured: Up to 5 years
Healthcare Resource Utilization Costs per Patient per Year
Healthcare utilization costs included costs for inpatient care, outpatient care, medication, and exams.
Measured: Up to 5 years
Hazard Ratio for Hyperkalemia
Measured: 180 days, 810 days, 1260 days
Rate of Dose Titration Events per 100-Person-Years
Rates were measured for dose titrations from:
- low to medium
- medium to low
- medium to high
- high to medium
Measured: 180 days, 810 days, 1260 days
Rate of Patients Reaching the Maximum Dose per 100-Person-Years
Measured: 180 days, 810 days, 1260 days
Rate of Treatment Discontinuation
Measured: 180 days, 810 days, 1260 days
Number of Patients by Demographic Category
Demographics included age and sex.
Measured: Baseline
Number of Patients by Clinical Characteristic Category
Clinical characteristics included:
- New York Heart Association (NYHA) Class
- eGFR ≥ 60 mL/minute/1.73 m^2
- eGFR < 60 mL/minute/1.73 m^2
- LVEF ≤ 35%
- LVEF > 35%
- Type of medication
- Comorbidities
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start20 Oct 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,249 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
- NCT07376265
- Sponsor's protocol ID
- CLCZ696BPT07
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Sacubitril/Valsartan vs ACEi/ARB in HFrEF Patients: Real Heart PT
- ClinicalTrials.gov ID
- NCT07376265
- Acronym / sponsor ID
- CLCZ696BPT07
- Conditions
- Heart Failure
- Keywords
- Sacubritril-valsartan, Heart failure, Cardiovascular outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,249 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 29 Jan 2026 (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 retrospective, observational, comparative cohort study using secondary data from electronic health records (EHR) from a local health unit that provides primary, secondary and tertiary care to a resident population in northern Portugal. The study aimed to assess the comparative effectiveness of sacubitril/valsartan (SAC/VAL) versus angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) in patients with heart failure with reduced ejection fraction (HFrEF).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAC/VAL Cohort | – | –Adult patients with HFrEF undergoing therapy with SAC/VAL. |
| ACEi/ARB Cohort | – | –Adult patients with HFrEF undergoing therapy with ACEi/ARB. |
| Missed Opportunities Cohort | – | –Patients who were eligible for but did not receive SAC/VAL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included heart failure patients with reduced ejection fraction.
Key inclusion criteria (3 listed)
- Left ventricular ejection fraction (LVEF) < 40%
- Brain natriuretic peptide (BNP) ≥35 pg/mL or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥125 pg/mL
- Had a record in the database in the 365 days prior to the index date
Key exclusion criteria (5 listed)
- Missing sex or date of birth
- Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m^2 at SAC/VAL, ACEi or ARB initiation
- History of angioedema or unacceptable side effects during receipt of SAC/VAL, ACEi or ARB
- Severe hepatic impairment, biliary cirrhosis, and cholestasis
- Pregnancy
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
Hazard Ratio for the Composite of Cardiovascular Death or Heart Failure Hospitalization
Time frame: 180 days, 810 days, 1260 days
20 secondary outcomes
Hazard Ratio for Death From Cardiovascular Causes
Time frame: 180 days, 810 days, 1260 days
Hazard Ratio for Hospitalization for Heart Failure
Time frame: 180 days, 810 days, 1260 days
Hazard Ratio for First Hospitalization or Emergency Room Visit
Time frame: 180 days, 810 days, 1260 days
Hazard Ratio for First Cardiovascular-specific Hospitalization
Time frame: 180 days, 810 days, 1260 days
Hazard Ratio for the Composite of Death From Cardiovascular Causes, Hospitalization for Heart Failure, Non-fatal Myocardial Infarction and Non-fatal Stroke
Time frame: 180 days, 810 days, 1260 days
Hazard Ratio for Implantable Cardioverter-defibrillator (ICD) Procedure
Time frame: 180 days, 810 days, 1260 days
Hazard Ratio for All-cause Mortality
Time frame: 180 days, 810 days, 1260 days
Hazard Ratio for Improved LVEF
Time frame: 180 days, 810 days, 1260 days
Pearson Correlation Coefficient Between Change From Baseline in NT-proBNP and LVEF
Time frame: 180 days, 810 days, 1260 days
Change From Baseline in NT-proBNP
Time frame: 180 days, 810 days, 1260 days
Change From Baseline in LVEF
Time frame: 180 days, 810 days, 1260 days
Total Healthcare Resource Utilization Costs per Calendar Year
Time frame: Up to 5 years
Number of Days Patients Were Absent From Work per Calendar Year
Time frame: Up to 5 years
Healthcare Resource Utilization Costs per Patient per Year
Time frame: Up to 5 years
Hazard Ratio for Hyperkalemia
Time frame: 180 days, 810 days, 1260 days
Rate of Dose Titration Events per 100-Person-Years
Time frame: 180 days, 810 days, 1260 days
Rate of Patients Reaching the Maximum Dose per 100-Person-Years
Time frame: 180 days, 810 days, 1260 days
Rate of Treatment Discontinuation
Time frame: 180 days, 810 days, 1260 days
Number of Patients by Demographic Category
Time frame: Baseline
Number of Patients by Clinical Characteristic Category
Time frame: Baseline
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 4 Feb 2026.
- Link to study resultsLink provided by the sponsor.
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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 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 3 inclusion and 5 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 4 Feb 2026. 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?
Hazard Ratio for the Composite of Cardiovascular Death or Heart Failure Hospitalization (time frame: 180 days, 810 days, 1260 days). 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 4 Feb 2026.