Heart FailureNCT05448872
Real World Experience in Heart Failure With Reduced Ejection Fraction (HFrEF) Patients Treated With sAc/vaL.
An observational study of Heart Failure, run by Novartis Pharmaceuticals at 1 site in Italy.
Trial summary
The study is a cohort observational, retrospective, non-interventional study. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sacubitril/Valsartan
- How many people
- 924 participants
- Where
- 1 siteItaly
- Study dates
- 23 Nov 2020to 15 Sep 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: Heart Failure with reduced Ejection Fraction (HfrEF) patients treated with Sacubitril/Valsartan.
Who may be able to join
- Consecutive ambulatory patients with a diagnosis of HF that attended the Outpatient Clinics for HF management and who have been prescribed Sacubitril/Valsartan from 01 October 2016 to 30 June 2019 (inclusion period) were included in the study. To allow for at least 1-year follow-up period for any patients, the observation period ended by 30 June 2020.
- In detail, all patients attending by outpatient clinics for the diagnosis and treatment of HF in the Italian Centers involved, with:
- age ≥18 years old AND
- at least one prescription of Sacubitril/Valsartan from 01 October 2016 to 30 June 2019 were included in the study.
Who cannot join
- Missing age or sex information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Experience in HFrEF Patients Treated With sAc/vaL in ITaly
The study is a cohort observational, retrospective, non-interventional study.
Read the detailed description
Study period:
Index date: The index date were defined as the first date of the first prescription of Sacubitril/Valsartan during inclusion period and this were used to establish the beginning of the follow-up period.
Characterization period: 6 months period before the index date were used to characterize patients.
Follow-up period: Any patients has at least 1 year of follow-up. Follow-up period went from index date to June 2020.
- Conditions
- Heart Failure
- Being tested
- Sacubitril/Valsartan
- Keywords
- Drug utilization,, Heart failure,, Real-world,, Sacubitril/Valsartan
- 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
HF patients treated with Sac/Val
| Study group | Role | What they receive |
|---|---|---|
| Sacubitril/Valsartan | Heart Failure (HF) patients treated with Sac/Val Receives: Drug: Sacubitril/Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
To describe the demographics
Measured: Baseline
Gender
To describe the demographics
Measured: Baseline
Number of patients with Ischemic heart disease
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with PCI/CABG: Percutaneous coronary intervention/coronary artery bypass grafting
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with moderate or severe mitral or aortic valvulopathy
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with Implanted prosthetic valve
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with ICD/CRT, Implantable Cardioverter Defibrillator/ Cardiac Resynchronization Therapy
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with Atrial fibrillation
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with prior hospitalization for HF
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with previous stroke
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with diabetes mellitus
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with Hypertension
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with Chronic kidney disease (CKD)
To evaluate clinical characteristics at baseline.
Measured: Baseline
Duration of HF disease
To evaluate clinical characteristics at baseline.
Measured: Baseline
Number of patients with pharmacological treatments for HF
To evaluate the pharmacological treatments for HF during characterization and follow-up.
Measured: throughout the study, approximately 3 years
Secondary outcomes (11)
Number of patients with initial and final doses
To evaluate the Sacubitril/Valsartan dosing pattern during follow-up
Measured: throughout the study, approximately 3 years
Number of patients with Non-maximum dose
To evaluate the Sacubitril/Valsartan dosing pattern during follow-up
Measured: throughout the study, approximately 3 years
Time to maximal dose prescribed
To evaluate the Sacubitril/Valsartan dosing pattern during follow-up
Measured: throughout the study, approximately 3 years
Number of patients with hospitalization HF-related
To evaluate frequency of cardiovascular (CV) and non-CV death.
Measured: throughout the study, approximately 3 years
Number of patients with hospitalization related to other cardiovascular events
To evaluate frequency of cardiovascular (CV) and non-CV death.
Measured: throughout the study, approximately 3 years
Number of patients with hospitalization related to non-CV cause
To evaluate frequency of cardiovascular (CV) and non-CV death.
Measured: throughout the study, approximately 3 years
Number of patients with Percutaneous Coronary Intervention (PCI)/coronary artery bypass grafting (CABG)
To evaluate frequency of cardiovascular (CV) and non-CV death.
Measured: throughout the study, approximately 3 years
Number of patients with Valvular intervention
To evaluate frequency of cardiovascular (CV) and non-CV death.
Measured: throughout the study, approximately 3 years
Number of patients with Device implantation (ICD/CRT)
To evaluate frequency of cardiovascular (CV) and non-CV death.
Measured: throughout the study, approximately 3 years
Number of patients with ER visits HF-related
To evaluate frequency of cardiovascular (CV) and non-CV death.
Measured: throughout the study, approximately 3 years
Number of deaths
To evaluate frequency of cardiovascular (CV) and non-CV death.
Measured: throughout the study, approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start23 Nov 2020
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
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
- 924 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
- NCT05448872
- Sponsor's protocol ID
- CLCZ696BIT08
- Status last verified
- Nov 2022
- First submitted
- 1 Jul 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Experience in HFrEF Patients Treated With sAc/vaL in ITaly
- ClinicalTrials.gov ID
- NCT05448872
- Acronym / sponsor ID
- CLCZ696BIT08
- Conditions
- Heart Failure
- Keywords
- Drug utilization,, Heart failure,, Real-world,, Sacubitril/Valsartan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 924 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 8 Jul 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.
The study is a cohort observational, retrospective, non-interventional study.
Detailed description
Study period:
Index date: The index date were defined as the first date of the first prescription of Sacubitril/Valsartan during inclusion period and this were used to establish the beginning of the follow-up period.
Characterization period: 6 months period before the index date were used to characterize patients.
Follow-up period: Any patients has at least 1 year of follow-up. Follow-up period went from index date to June 2020.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacubitril/Valsartan | – | Drug: Sacubitril/ValsartanHeart Failure (HF) patients treated with Sac/Val |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Failure with reduced Ejection Fraction (HfrEF) patients treated with Sacubitril/Valsartan.
Key inclusion criteria (4 listed)
- Consecutive ambulatory patients with a diagnosis of HF that attended the Outpatient Clinics for HF management and who have been prescribed Sacubitril/Valsartan from 01 October 2016 to 30 June 2019 (inclusion period) were included in the study. To allow for at least 1-year follow-up period for any patients, the observation period ended by 30 June 2020.
- In detail, all patients attending by outpatient clinics for the diagnosis and treatment of HF in the Italian Centers involved, with:
- age ≥18 years old AND
- at least one prescription of Sacubitril/Valsartan from 01 October 2016 to 30 June 2019 were included in the study.
Key exclusion criteria (1 listed)
- Missing age or sex information.
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/ValsartanHF patients treated with Sac/Val | Drug | Sacubitril/Valsartan |
Primary outcome
Age
Time frame: Baseline
To describe the demographics
Gender
Time frame: Baseline
To describe the demographics
Number of patients with Ischemic heart disease
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with PCI/CABG: Percutaneous coronary intervention/coronary artery bypass grafting
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with moderate or severe mitral or aortic valvulopathy
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with Implanted prosthetic valve
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with ICD/CRT, Implantable Cardioverter Defibrillator/ Cardiac Resynchronization Therapy
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with Atrial fibrillation
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with prior hospitalization for HF
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with previous stroke
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with diabetes mellitus
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with Hypertension
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with Chronic kidney disease (CKD)
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Duration of HF disease
Time frame: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with pharmacological treatments for HF
Time frame: throughout the study, approximately 3 years
To evaluate the pharmacological treatments for HF during characterization and follow-up.
11 secondary outcomes
Number of patients with initial and final doses
Time frame: throughout the study, approximately 3 years
Number of patients with Non-maximum dose
Time frame: throughout the study, approximately 3 years
Time to maximal dose prescribed
Time frame: throughout the study, approximately 3 years
Number of patients with hospitalization HF-related
Time frame: throughout the study, approximately 3 years
Number of patients with hospitalization related to other cardiovascular events
Time frame: throughout the study, approximately 3 years
Number of patients with hospitalization related to non-CV cause
Time frame: throughout the study, approximately 3 years
Number of patients with Percutaneous Coronary Intervention (PCI)/coronary artery bypass grafting (CABG)
Time frame: throughout the study, approximately 3 years
Number of patients with Valvular intervention
Time frame: throughout the study, approximately 3 years
Number of patients with Device implantation (ICD/CRT)
Time frame: throughout the study, approximately 3 years
Number of patients with ER visits HF-related
Time frame: throughout the study, approximately 3 years
Number of deaths
Time frame: throughout the study, approximately 3 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 8 Nov 2022.
- Results for CLCZ696BIT08 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 Heart Failure, run by Novartis Pharmaceuticals at 1 site in Italy.
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 4 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 8 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 Italy. 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?
Age (time frame: Baseline). The study lists 15 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 Nov 2022.