Heart FailureNCT05096143
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
An observational study of Heart Failure, run by Novartis Pharmaceuticals at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sacubitril/valsartan and ACEi/ARB
- How many people
- 42,269 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2020to 19 Oct 2020
- 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 to 85 years
- 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
- 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).
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- 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936
About this study
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.
Read the detailed 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
- Conditions
- Heart Failure
- Being tested
- Sacubitril/valsartan, ACEi/ARB
- Keywords
- Heart failure hospitalizations,, sacubitril/valsartan,, Angiotensin II receptor antagonist,, United States,, electronic health record
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacubitril/valsartanDrug
Also called Entresto®
Participants who were prescribed with Sacubitril/valsartan
ACEi/ARBDrug
Participants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)
| Study group | Role | What they receive |
|---|---|---|
| Naive Sacubitril/valsartan | Participants who were prescribed with Naive Sacubitril/valsartan Receives: Drug: Sacubitril/valsartan | |
| Naive ACEi/ARB | Participants who were prescribed with Naive Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB) Receives: Drug: ACEi/ARB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, maximum 5 years
Secondary outcomes (7)
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.
Measured: through study completion, maximum 5 years
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.
Measured: through study completion, maximum 5 years
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.
Measured: through study completion, maximum 5 years
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.
Measured: through study completion, maximum 5 years
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.
Measured: through study completion, maximum 5 years
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.
Measured: through study completion, maximum 5 years
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
Measured: through study completion, maximum 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 Oct 2021
- Study start3 Jun 2020
- Primary completion19 Oct 2020
- Study completion19 Oct 2020
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
- 42,269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096143
- Sponsor's protocol ID
- CLCZ696B2036
- Status last verified
- Dec 2021
- First submitted
- 19 Oct 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05096143
- Acronym / sponsor ID
- CLCZ696B2036
- Conditions
- Heart Failure
- Keywords
- Heart failure hospitalizations,, sacubitril/valsartan,, Angiotensin II receptor antagonist,, United States,, electronic health record
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42,269 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 19 Oct 2020 (actual)
- Study completion
- 19 Oct 2020 (actual)
- First posted
- 27 Oct 2021 (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.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naive Sacubitril/valsartan | – | Drug: Sacubitril/valsartanParticipants who were prescribed with Naive Sacubitril/valsartan |
| Naive ACEi/ARB | – | Drug: ACEi/ARBParticipants who were prescribed with Naive Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB) |
Who may qualify
- Ages
- 18 to 85 years
- 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 (13 listed)
- 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.
Key exclusion criteria (16 listed)
- Sacubitril/valsartan incident cohort
- 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).
- Patients who were prescribed sacubitril/valsartan prior to index date.
- Patients who were prescribed ACEi or ARBs prior to index date (index date included).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacubitril/valsartanAlso: Entresto®Participants who were prescribed with Sacubitril/valsartan | Drug | Naive Sacubitril/valsartan |
| ACEi/ARBParticipants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB) | Drug | Naive ACEi/ARB |
Primary outcome
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
Time frame: through study completion, maximum 5 years
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.
7 secondary outcomes
Rate of HF hospitalizations events for both Truly naive sacubitril/valsartan HFrEF patients and Truly naive ACEi/ARB HFrEF patients
Time frame: through study completion, maximum 5 years
Time to first HF hospitalization for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
Time frame: through study completion, maximum 5 years
Rate of HF hospitalizations or Emergency room (ER) visits for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
Time frame: through study completion, maximum 5 years
Time to first HF hospitalization or HF ER visit for both Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
Time frame: through study completion, maximum 5 years
Rate of all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
Time frame: through study completion, maximum 5 years
Time to first all-cause hospitalizations events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
Time frame: through study completion, maximum 5 years
Rates of cardiovascular hospitalization events between Naive sacubitril/valsartan HFrEF patients and Naive ACEi/ARB HFrEF patients
Time frame: through study completion, maximum 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 21 Dec 2021.
- Results for CLCZ696B2036 from the Novartis Clinical Trials WebsiteLink 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.
The record lists no contact. Use the official record to reach the sponsor.
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 13 inclusion and 16 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 21 Dec 2021. 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?
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 (time frame: through study completion, maximum 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 21 Dec 2021.