Clinical trial NCT05448872: Real World Experience in Heart Failure With Reduced Ejection Fraction (HFrEF) Patients Treated With sAc/vaL.
Official title: Real World Experience in HFrEF Patients Treated With sAc/vaL in ITaly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Drug utilization,
Heart failure,
Real-world,
Sacubitril/Valsartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-07-08
Enrollment: 924
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Failure with reduced Ejection Fraction (HfrEF) patients treated with Sacubitril/Valsartan.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* Missing age or sex information.

Primary outcomes:
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Number of patients with Ischemic heart disease
timeFrame: Baseline
measure: Number of patients with PCI/CABG: Percutaneous coronary intervention/coronary artery bypass grafting
timeFrame: Baseline
measure: Number of patients with moderate or severe mitral or aortic valvulopathy
timeFrame: Baseline
measure: Number of patients with Implanted prosthetic valve
timeFrame: Baseline
measure: Number of patients with ICD/CRT, Implantable Cardioverter Defibrillator/ Cardiac Resynchronization Therapy
timeFrame: Baseline
measure: Number of patients with Atrial fibrillation
timeFrame: Baseline
measure: Number of patients with prior hospitalization for HF
timeFrame: Baseline
measure: Number of patients with previous stroke
timeFrame: Baseline
measure: Number of patients with diabetes mellitus
timeFrame: Baseline
measure: Number of patients with Hypertension
timeFrame: Baseline
measure: Number of patients with Chronic kidney disease (CKD)
timeFrame: Baseline
measure: Duration of HF disease
timeFrame: Baseline
measure: Number of patients with pharmacological treatments for HF
timeFrame: throughout the study, approximately 3 years
Secondary outcomes:
measure: Number of patients with initial and final doses
timeFrame: throughout the study, approximately 3 years
measure: Number of patients with Non-maximum dose
timeFrame: throughout the study, approximately 3 years
measure: Time to maximal dose prescribed
timeFrame: throughout the study, approximately 3 years
measure: Number of patients with hospitalization HF-related
timeFrame: throughout the study, approximately 3 years
measure: Number of patients with hospitalization related to other cardiovascular events
timeFrame: throughout the study, approximately 3 years
measure: Number of patients with hospitalization related to non-CV cause
timeFrame: throughout the study, approximately 3 years
measure: Number of patients with Percutaneous Coronary Intervention (PCI)/coronary artery bypass grafting (CABG)
timeFrame: throughout the study, approximately 3 years
measure: Number of patients with Valvular intervention
timeFrame: throughout the study, approximately 3 years
measure: Number of patients with Device implantation (ICD/CRT)
timeFrame: throughout the study, approximately 3 years
measure: Number of patients with ER visits HF-related
timeFrame: throughout the study, approximately 3 years
measure: Number of deaths
timeFrame: throughout the study, approximately 3 years
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: