Heart Failure With Reduced Ejection FractionNCT06671314
Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
An observational study of Heart Failure With Reduced Ejection Fraction and Heart Failure With Preserved Ejection Fraction, run by Novartis at 1 site in United States.
Trial summary
This was a retrospective observational cohort study using patient data from the Get With The Guideline-Heart Failure (GWTG-HF) registry linked to Medicare Fee-for-Service (FFS) claims. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction
- How many people
- 42,494 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2022to 31 Oct 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Hospitalized for heart failure from 01 January 2016 to 30 September 2021.
- Were discharged alive (any discharge disposition other than "Expired").
- Had Mildly reduced or preserved ejection fraction (41% to 60%).
- Had non-missing record of SAC/VAL use at discharge.
- Continuously enrolled in Medicare Part A \& B for the 12 months following the index HF hospitalization discharge date or until death.
Who cannot join
- Patients who left against medical advice (AMA), were transferred to an acute care facility, or discharged to hospice care.
- Patients who had dialysis as an in-hospital procedure.
- Patients with a medical history of chronic dialysis.
- Patients with an in-hospital procedure of heart transplantation.
- Patients with a medical history of heart transplantation.
- Patients with an in-hospital procedure of left ventricular assist device.
- Patients with a medical history of left ventricular assist device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: Adoption of Novel Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
This was a retrospective observational cohort study using patient data from the Get With The Guideline-Heart Failure (GWTG-HF) registry linked to Medicare Fee-for-Service (FFS) claims. The main goal of the study was to compare home-time in Medicare FFS patients with heart failure with mildly reduced or preserved ejection fraction discharged with sacubitril/valsartan versus those discharged without sacubitril/valsartan.
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 |
|---|---|---|
| Heart Failure Cohort | Adults hospitalized with heart failure from the Get With The Guidelines - Heart Failure (GWTG-HF) registry and enrolled in Medicare Fee-for-Service at the time of discharge. Patients had heart failure with preserved or mildly reduced ejection fraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status
Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.
SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Measured: Post-discharge at Day 30
Time Spent 90 Days Post-discharge by Discharge SAC/VAL Prescription Status
Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.
SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Measured: Post-discharge at Day 90
Time Spent 180 Days Post-discharge by Discharge SAC/VAL Prescription Status
Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.
SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Measured: Post-discharge at Day 180
Time Spent 365 Days Post-discharge by Discharge SAC/VAL Prescription Status
Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.
SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Measured: Post-discharge at Day 365
Secondary outcomes (24)
Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge With a Sacubitril/Valsartan (SAC/VAL) Prescription
Measured: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
Measured: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Mortality or Heart Failure (HF) Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription
Measured: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Mortality or HF Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
Measured: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With SAC/VAL Prescription
All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation.
Measured: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
All-cause hospitalization was defined as any inpatient claim for post-discharge admission to an acute care hospital excluding transfers and hospitalizations for rehabilitation.
Measured: Post-discharge at Days 30, 90, 180, and 365
Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription
HF hospitalization was defined as any inpatient claim with a primary diagnosis of HF (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM] diagnosis codes I098.1, I50.*, I11.0, I13.0, I13.2) excluding transfers.
Measured: Post-discharge at Days 30, 90, 180, and 365
Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
HF hospitalization was defined as any inpatient claim with a primary diagnosis of HF (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM] diagnosis codes I098.1, I50.*, I11.0, I13.0, I13.2) excluding transfers.
Measured: Post-discharge at Days 30, 90, 180, and 365
Number Patients Hospitalized for Dialysis or End-Stage Kidney Disease at 365 Days After Discharge With and Without a SAC/VAL Prescription
Hospitalization for dialysis or end-stage kidney disease was defined as any inpatient claim having a primary diagnosis of dialysis or end-stage kidney disease (International Classification of Diseases, 10th revision, Clinical Modification [ICD-10-CM] diagnosis codes Z99.2, Z49, N18.5, N18.6; or ICD.9 - 585.6, V45.11, V56.0, V56.8)
Measured: Post-discharge at Day 365
Number Patients Hospitalized for a Metabolic/Nutritional Disorder at 365 Days After Discharge With and Without a SAC/VAL Prescription
Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641.
Measured: Post-discharge at Day 365
Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription
Hospitalization for urinary tract infection was defined as any inpatient claims with a primary diagnosis of International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) code N39.0.
Measured: Post-discharge at Day 365
Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription
Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur.
Measured: Post-discharge at Day 365
Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription
Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility.
Measured: Post-discharge at Days 30, 90, 180, and 365
Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription
Measured: Post-discharge at Days 30, 90, 180, and 365
Difference in Composite Measure Between Discharge With and Without SAC/VAL Prescription
Composite measure: all-cause mortality or heart failure hospitalization.
Measured: Post-discharge at Days 30, 90, 180, and 365
Difference in All-cause Re-hospitalization Between Discharge With and Without SAC/VAL Prescription
Measured: Post-discharge at Days 30, 90, 180, and 365
Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription
Measured: Post-discharge at Days 30, 90, 180, and 365
Difference in Hospitalization for Metabolic/Nutritional Disorder Between Discharge With and Without SAC/VAL Prescription
Hospitalization for metabolic/nutritional reasons was defined as any inpatient claims with Diagnosis-related group (DRG) codes 640, 641.
Measured: Post-discharge at Day 365
Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription
Hospitalization for urinary tract infection was defined as any inpatient claims with a primary diagnosis of International Classification of Diseases, 10th revision, Clinical Modification (ICD-10-CM) code N39.0.
Measured: Post-discharge at Day 365
Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription
Hospitalization for hip fracture was defined as any inpatient claims with a primary diagnosis fracture of the neck of the femur.
Measured: Post-discharge at Day 365
Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status
SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Measured: Post-discharge at Day 365
Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status
SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Measured: Post-discharge at Day 365
All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status
SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Measured: Post-discharge at Day 365
All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status
SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Measured: Post-discharge at Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start2 Jun 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- 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
- 42,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671314
- Sponsor's protocol ID
- CLCZ696DUS07
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adoption of Novel Heart Failure Therapy and Outcomes in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT06671314
- Acronym / sponsor ID
- CLCZ696DUS07
- Conditions
- Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42,494 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 4 Nov 2024 (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 cohort study using patient data from the Get With The Guideline-Heart Failure (GWTG-HF) registry linked to Medicare Fee-for-Service (FFS) claims. The main goal of the study was to compare home-time in Medicare FFS patients with heart failure with mildly reduced or preserved ejection fraction discharged with sacubitril/valsartan versus those discharged without sacubitril/valsartan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Cohort | – | –Adults hospitalized with heart failure from the Get With The Guidelines - Heart Failure (GWTG-HF) registry and enrolled in Medicare Fee-for-Service at the time of discharge. Patients had heart failure with preserved or mildly reduced ejection fraction. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (5 listed)
- Hospitalized for heart failure from 01 January 2016 to 30 September 2021.
- Were discharged alive (any discharge disposition other than "Expired").
- Had Mildly reduced or preserved ejection fraction (41% to 60%).
- Had non-missing record of SAC/VAL use at discharge.
- Continuously enrolled in Medicare Part A \& B for the 12 months following the index HF hospitalization discharge date or until death.
Key exclusion criteria (7 listed)
- Patients who left against medical advice (AMA), were transferred to an acute care facility, or discharged to hospice care.
- Patients who had dialysis as an in-hospital procedure.
- Patients with a medical history of chronic dialysis.
- Patients with an in-hospital procedure of heart transplantation.
- Patients with a medical history of heart transplantation.
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
Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status
Time frame: Post-discharge at Day 30
Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Time Spent 90 Days Post-discharge by Discharge SAC/VAL Prescription Status
Time frame: Post-discharge at Day 90
Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Time Spent 180 Days Post-discharge by Discharge SAC/VAL Prescription Status
Time frame: Post-discharge at Day 180
Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
Time Spent 365 Days Post-discharge by Discharge SAC/VAL Prescription Status
Time frame: Post-discharge at Day 365
Time spent included home-time days, hospital days, skilled nursing facility days, rehab days, other institutional days, and death days. Home-time was defined as the number of days alive and out of the hospital, skilled nursing facility or inpatient rehabilitation facility. SAC/VAL prescription status: with SAC/VAL prescription and without SAC/VAL prescription.
24 secondary outcomes
Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge With a Sacubitril/Valsartan (SAC/VAL) Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Mortality Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Mortality or Heart Failure (HF) Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Mortality or HF Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge With SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Number of All-cause Hospitalization Patients at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge With a SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Number of Patients Hospitalized for HF at 30, 90, 180, and 365 Days After Discharge Without a SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Number Patients Hospitalized for Dialysis or End-Stage Kidney Disease at 365 Days After Discharge With and Without a SAC/VAL Prescription
Time frame: Post-discharge at Day 365
Number Patients Hospitalized for a Metabolic/Nutritional Disorder at 365 Days After Discharge With and Without a SAC/VAL Prescription
Time frame: Post-discharge at Day 365
Number Patients Hospitalized for Urinary Tract Infection at 365 Days After Discharge With and Without a SAC/VAL Prescription
Time frame: Post-discharge at Day 365
Number Patients Hospitalized for a Hip Fracture at 365 Days After Discharge With and Without a SAC/VAL Prescription
Time frame: Post-discharge at Day 365
Difference in Days of Home-time Between Discharge With and Without SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Difference in All-cause Mortality Between Discharge With and Without SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Difference in Composite Measure Between Discharge With and Without SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Difference in All-cause Re-hospitalization Between Discharge With and Without SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Difference in HF Re-hospitalization Between Discharge With and Without SAC/VAL Prescription
Time frame: Post-discharge at Days 30, 90, 180, and 365
Difference in Hospitalization for Metabolic/Nutritional Disorder Between Discharge With and Without SAC/VAL Prescription
Time frame: Post-discharge at Day 365
Difference in Hospitalization for Urinary Tract Infection Between Discharge With and Without SAC/VAL Prescription
Time frame: Post-discharge at Day 365
Difference in Hospitalization for Hip Fracture Between Discharge With and Without SAC/VAL Prescription
Time frame: Post-discharge at Day 365
Number of All-cause Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status
Time frame: Post-discharge at Day 365
Number of HF Re-hospitalizations per Patient by Discharge SAC/VAL Prescription Status
Time frame: Post-discharge at Day 365
All-cause Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status
Time frame: Post-discharge at Day 365
All-cause HF-related Re-hospitalization Length of Stay by Discharge SAC/VAL Prescription Status
Time frame: Post-discharge at Day 365
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 Nov 2024.
Related trials for Heart Failure With Reduced Ejection Fraction
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Recruiting
Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction
Heart Failure With Reduced Ejection Fraction (HFrEF)
RecruitingObservational study
Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function
Inflammation Biomarkers, Heart Failure
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 With Reduced Ejection Fraction and Heart Failure With Preserved Ejection Fraction, run by Novartis 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 5 inclusion and 7 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 Nov 2024. 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?
Time Spent 30 Days Post-discharge by Discharge Sacubitril/Valsartan (SAC/VAL) Prescription Status (time frame: Post-discharge at Day 30). The study lists 4 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 4 Nov 2024.