Chronic Heart FailureNCT05848206
Impact of Formulary Coverage of Entresto (Sacubitril/Valsartan) on Prescription Abandonment/Rejection and Subsequent Treatment and Economic Outcomes in Chronic Heart Failure Patients in the U.S.
An observational study of Chronic Heart Failure, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a retrospective cohort study utilizing IQVIA open-source pharmacy and medical claims data among patients with a sacubitril/valsartan (SAC/VAL) prescription transaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- How many people
- 251,831 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2022to 29 Apr 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
- Primary IQVIA Longitudinal Access and Adjudication Data (LAAD) Cohort (for primary objective)
- Patients with ≥1 transaction for SAC/VAL in LAAD between 01 January 2017 and 30 November 2019 (index period). Date of the 1st SAC/VAL prescription transaction during this period was the index date.
- Patients from the Novartis-provided list of 21 plans and formularies of interest (mapping to LAAD data was based data elements such as plan name, payer name, and pharmacy benefit manager [PBM] name) as of the index date.
- Patients aged ≥18 years on the index date.
- Patients with 12-months of data visibility pre-index.
- Patients with 3-months of data visibility post-index (to allow for final adjudication/abandonment status confirmation).
Show all 17Show fewer
- For comorbidity data only:
- Patients with linkage of LAAD FIA to LAAD Dx by patient ID.
- Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.
- Secondary LAAD Cohort (for secondary objective)
- Among patients from the Primary LAAD Cohort remaining in Step 6, patients who abandoned their 1st SAC/VAL prescription or did not receive SAC/VAL due to claim rejection in LAAD between 01 January 2017 and 28 February 2019 (index period). Date of the 1st abandoned/rejected SAC/VAL prescription transaction during this period is the index date.
- Patients aged ≥18 years on the index date.
- Patients with 12-months of data visibility pre-index.
- Patients with 12-months of data visibility post-index.
- For comorbidity data only:
- Patients with linkage of LAAD FIA to LAAD Dx by patient ID.
- Patients with ≥2 non-ancillary medical claims ≥30 days apart within the 12 months pre-index period.
Who cannot join
- Patients with a SAC/VAL transaction during the 12-month pre-index period.
- Patients with data quality issues (e.g., missing gender).
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective cohort study utilizing IQVIA open-source pharmacy and medical claims data among patients with a sacubitril/valsartan (SAC/VAL) prescription transaction.
- Conditions
- Chronic 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 |
|---|---|---|
| Primary LAAD Cohort | Patients with ≥1 SAC/VAL transactions from plans of interest identified in LAAD | |
| Secondary LAAD Cohort | Patients with SAC/VAL abandonment or rejection identified in LAAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who had SAC/VAL prescriptions filled
Measured: Up to 3 months
Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions
Measured: Up to 3 months
Percentage of patients who had SAC/VAL prescriptions rejected by an insurance payer
Measured: Up to 3 months
Secondary outcomes (3)
Percentage of patients who utilized a heart failure-related treatment in the follow-up period
Measured: Up to 12 months
Time to first angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blockers (ARB), or angiotensin-receptor neprilysin inhibitors (ARNI, i.e., SAC/VAL) in the follow-up period
Measured: Up to 12 months
Percentage of patients who had a disruption in the use of ACEi/ARB/ARNI in the follow-up period
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start11 Mar 2022
- Primary completion29 Apr 2022
- Study completion29 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 251,831 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
- NCT05848206
- Sponsor's protocol ID
- CLCZ696BUS34
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Formulary Coverage of Entresto (Sacubitril/Valsartan) on Prescription Abandonment/Rejection and Subsequent Treatment and Economic Outcomes in Chronic Heart Failure Patients in the U.S.
- ClinicalTrials.gov ID
- NCT05848206
- Acronym / sponsor ID
- CLCZ696BUS34
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251,831 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 29 Apr 2022 (actual)
- First posted
- 8 May 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 retrospective cohort study utilizing IQVIA open-source pharmacy and medical claims data among patients with a sacubitril/valsartan (SAC/VAL) prescription transaction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary LAAD Cohort | – | –Patients with ≥1 SAC/VAL transactions from plans of interest identified in LAAD |
| Secondary LAAD Cohort | – | –Patients with SAC/VAL abandonment or rejection identified in LAAD |
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 (17 listed)
- Primary IQVIA Longitudinal Access and Adjudication Data (LAAD) Cohort (for primary objective)
- Patients with ≥1 transaction for SAC/VAL in LAAD between 01 January 2017 and 30 November 2019 (index period). Date of the 1st SAC/VAL prescription transaction during this period was the index date.
- Patients from the Novartis-provided list of 21 plans and formularies of interest (mapping to LAAD data was based data elements such as plan name, payer name, and pharmacy benefit manager [PBM] name) as of the index date.
- Patients aged ≥18 years on the index date.
- Patients with 12-months of data visibility pre-index.
Key exclusion criteria (2 listed)
- Patients with a SAC/VAL transaction during the 12-month pre-index period.
- Patients with data quality issues (e.g., missing gender).
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
Percentage of patients who had SAC/VAL prescriptions filled
Time frame: Up to 3 months
Percentage of patients who had abandoned (not accepted) SAC/VAL prescriptions
Time frame: Up to 3 months
Percentage of patients who had SAC/VAL prescriptions rejected by an insurance payer
Time frame: Up to 3 months
3 secondary outcomes
Percentage of patients who utilized a heart failure-related treatment in the follow-up period
Time frame: Up to 12 months
Time to first angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blockers (ARB), or angiotensin-receptor neprilysin inhibitors (ARNI, i.e., SAC/VAL) in the follow-up period
Time frame: Up to 12 months
Percentage of patients who had a disruption in the use of ACEi/ARB/ARNI in the follow-up period
Time frame: Up to 12 months
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 8 May 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 Chronic 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 17 inclusion and 2 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 8 May 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?
Percentage of patients who had SAC/VAL prescriptions filled (time frame: Up to 3 months). The study lists 3 primary outcomes in all. 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 8 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.