Chronic Heart FailureNCT05613140
Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure
An observational study of Chronic Heart Failure, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1)… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- sacubitril/valsartan
- How many people
- 9,230 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 5 Nov 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with heart failure with reduced ejection fraction (HFrEF) and adult patients with chronic heart failure (CHF)
Who may be able to join
- Cohort 1 - Adult HFrEF patients
- Newly initiated sacubitril/valsartan during the cohort identification period;
- Presence of an International Classification of Diseases, Tenth revision (ICD-10) diagnosis code for systolic HF (I50.1x, I50.2x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
- That are ≥ 18 years old at index date;
- That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
- That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed.
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- Cohort 2 - Adult CHF patients
- Newly initiated sacubitril/valsartan during the cohort identification period;
- Presence of ICD-10 diagnosis code for systolic HF or diastolic HF (I50.1x, I50.2x, I50.3x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
- That are ≥ 18 years old at index date;
- That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
- That are continuously enrolled in medical and prescription pharmacy benefits in both the pre-index and post-index period, with any gap in coverage of <45 days allowed.
Who cannot join
- Patients who died during the post-index period will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936-1080
About this study
Official title: A Pre-post Analysis of Healthcare Resource Utilization and Costs of Care in a New User Cohort of Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure
This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).
Read the detailed description
This was a non-interventional, retrospective cohort study using secondary data sources from the Optum Clinformatics® Data Mart (CDM) and 100% files of the CMS Medicare RIFs.
Two study cohorts were constructed to include adult Heart Failure with reduced ejection fraction (HFrEF) patients who newly initiated sacubitril/valsartan (Cohort 1) and adult Chronic Heart Failure (CHF) patients who newly initiated sacubitril/valsartan (Cohort 2).
The date of first prescription fill for sacubitril/valsartan during the cohort identification period was defined as index date. A 12-month washout period was employed to ascertain the "new user" status. The Healthcare Resource Utilization (HCRU) and costs of care outcomes will be measured within both the 12 months post-index period and the 12 months pre-index period.
- Conditions
- Chronic Heart Failure
- Being tested
- sacubitril/valsartan
- Keywords
- Heart failure,, Medicare Advantage,, Commercial,, HFrEF,, Chronic heart failure
- 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
Two study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2).
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - Adult HFrEF patients | adult HFrEF patients who newly initiated sacubitril/valsartan Receives: Drug: sacubitril/valsartan | |
| Cohort 2 - Adult CHF patients | adult CHF patients who newly initiated sacubitril/valsartan Receives: Drug: sacubitril/valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Number of Heart Failure (HF)-specific hospitalizations was defined as the number of acute inpatient hospitalizations with a primary discharge diagnosis of HF. An acute inpatient hospitalization was defined as a medical claim for an inpatient hospitalization.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Secondary outcomes (13)
Mean number of HF - related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Number of HF-related hospitalizations was defined as the number of acute inpatient hospitalizations with a discharge diagnosis of HF in any position.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Number of all-cause hospitalizations was as the number of acute inpatient hospitalizations for any reason.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of Urgent Heart Failure (UHF) visits of adult HFrEF patients treated with sacubitril/valsartan
An UHF visit was defined as any of the following:
- a patient with a place of service (POS) code 20, which corresponds to urgent care facility ii) a patient with an ER visit that was outpatient (POS code = 22, 23), identified from revenue codes: 0450, 0451, 0452, 0456 or 0459 iii) a patient with an urgent care clinic visit that was outpatient (POS code = 22, 23), identified from revenue codes: 0516 or 0526 iv) a patient with a hospital observational stay (POS code = 22, 23), identified from revenue code 0762
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of Worsening Heart Failure (WHF) episodes of adult HFrEF patients treated with sacubitril/valsartan
Number of WHF episodes was defined as a composite outcome of HF-specific hospitalizations and UHF visits.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of HF-specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Costs of HF-specific hospitalizations was defined as the sum of payer paid amounts for acute inpatient hospitalizations with a primary discharge diagnosis of HF.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of HF-related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Costs of HF-related hospitalizations were defined as the sum of payer paid amounts for acute inpatient hospitalizations with a discharge diagnosis of HF in any position.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Costs of all-cause hospitalizations were defined as the sum of payer paid amounts for acute inpatient hospitalizations for any reason.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of UHF visits of adult HFrEF patients treated with sacubitril/valsartan
Costs of UHF visits were defined as the sum of payer paid amounts for UHF visits.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of WHF episodes of adult HFrEF patients treated with sacubitril/valsartan
Costs of WHF episodes were defined as the sum of payer paid amounts for HF-specific hospitalizations and UHF visits.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean HF-specific costs of adult HFrEF patients treated with sacubitril/valsartan
HF-related costs were defined as the sum of payer paid amounts for medical claims with a diagnosis of HF in any position.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean all-cause medical costs of adult HFrEF patients treated with sacubitril/valsartan
All-cause medical costs were defined as the sum of payer paid amounts for all medical claims.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean all-cause pharmacy costs of adult HFrEF patients treated with sacubitril/valsartan
All-cause pharmacy costs were defined as the sum of payer paid amounts for all pharmacy claims.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Mean all-cause total cost of care of adult HFrEF patients treated with sacubitril/valsartan
All-cause total cost of care were defined as the sum of all-cause medical costs and all-cause pharmacy costs.
Measured: Baseline, 12 months post initiation of sacubitril/valsartan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start2 Aug 2021
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
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
- 9,230 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
- NCT05613140
- Sponsor's protocol ID
- CLCZ696BUS33
- Status last verified
- Nov 2022
- First submitted
- 5 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-post Analysis of Healthcare Resource Utilization and Costs of Care in a New User Cohort of Sacubitril/Valsartan Treated Adult Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05613140
- Acronym / sponsor ID
- CLCZ696BUS33
- Conditions
- Chronic Heart Failure
- Keywords
- Heart failure,, Medicare Advantage,, Commercial,, HFrEF,, Chronic heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,230 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 14 Nov 2022 (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 study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).
Detailed description
This was a non-interventional, retrospective cohort study using secondary data sources from the Optum Clinformatics® Data Mart (CDM) and 100% files of the CMS Medicare RIFs.
Two study cohorts were constructed to include adult Heart Failure with reduced ejection fraction (HFrEF) patients who newly initiated sacubitril/valsartan (Cohort 1) and adult Chronic Heart Failure (CHF) patients who newly initiated sacubitril/valsartan (Cohort 2).
The date of first prescription fill for sacubitril/valsartan during the cohort identification period was defined as index date. A 12-month washout period was employed to ascertain the "new user" status. The Healthcare Resource Utilization (HCRU) and costs of care outcomes will be measured within both the 12 months post-index period and the 12 months pre-index period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 - Adult HFrEF patients | – | Drug: sacubitril/valsartanadult HFrEF patients who newly initiated sacubitril/valsartan |
| Cohort 2 - Adult CHF patients | – | Drug: sacubitril/valsartanadult CHF patients who newly initiated sacubitril/valsartan |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with heart failure with reduced ejection fraction (HFrEF) and adult patients with chronic heart failure (CHF)
Key inclusion criteria (12 listed)
- Cohort 1 - Adult HFrEF patients
- Newly initiated sacubitril/valsartan during the cohort identification period;
- Presence of an International Classification of Diseases, Tenth revision (ICD-10) diagnosis code for systolic HF (I50.1x, I50.2x, I50.4x) on one inpatient hospital claim or two outpatient medical claims during the cohort identification period;
- That are ≥ 18 years old at index date;
- That are treated with sacubitril/valsartan continuously for a minimum of 90-days following treatment initiation;
Key exclusion criteria (1 listed)
- Patients who died during the post-index period will be excluded.
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/valsartanTwo study cohorts were constructed to include adult HFrEF patients who newly initiated sacubitril/valsartan (Cohort 1) and adult CHF patients who newly initiated sacubitril/valsartan (Cohort 2). | Drug | Cohort 1 - Adult HFrEF patients, Cohort 2 - Adult CHF patients |
Primary outcome
Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Number of Heart Failure (HF)-specific hospitalizations was defined as the number of acute inpatient hospitalizations with a primary discharge diagnosis of HF. An acute inpatient hospitalization was defined as a medical claim for an inpatient hospitalization.
13 secondary outcomes
Mean number of HF - related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of Urgent Heart Failure (UHF) visits of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean number of Worsening Heart Failure (WHF) episodes of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of HF-specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of HF-related hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of all-cause hospitalizations of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of UHF visits of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean costs of WHF episodes of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean HF-specific costs of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean all-cause medical costs of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean all-cause pharmacy costs of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
Mean all-cause total cost of care of adult HFrEF patients treated with sacubitril/valsartan
Time frame: Baseline, 12 months post initiation of sacubitril/valsartan
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 15 Nov 2022.
- Results for CLCZ696BUS33 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 12 inclusion and 1 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 15 Nov 2022. 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?
Mean number of Heart Failure - specific hospitalizations of adult HFrEF patients treated with sacubitril/valsartan (time frame: Baseline, 12 months post initiation of sacubitril/valsartan). 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 15 Nov 2022.