Real World Experience in Heart Failure With Reduced Ejection Fraction (HFrEF) Patients Treated With sAc/vaL.

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT05448872

Collaborator

(none)

924

Enrollment

Location

9.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is a cohort observational, retrospective, non-interventional study.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: Sacubitril/Valsartan

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

Study Type:

Observational

Actual Enrollment :

924 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Real World Experience in HFrEF Patients Treated With sAc/vaL in ITaly

Actual Study Start Date :

Nov 23, 2020

Actual Primary Completion Date :

Sep 15, 2021

Actual Study Completion Date :

Sep 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sacubitril/Valsartan Heart Failure (HF) patients treated with Sac/Val	Drug: Sacubitril/Valsartan HF patients treated with Sac/Val

Arm

Intervention/Treatment

Sacubitril/Valsartan

Heart Failure (HF) patients treated with Sac/Val

Drug: Sacubitril/Valsartan

HF patients treated with Sac/Val

Outcome Measures

Primary Outcome Measures

Age [Baseline]
To describe the demographics
Gender [Baseline]
To describe the demographics
Number of patients with Ischemic heart disease [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with PCI/CABG: Percutaneous coronary intervention/coronary artery bypass grafting [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with moderate or severe mitral or aortic valvulopathy [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with Implanted prosthetic valve [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with ICD/CRT, Implantable Cardioverter Defibrillator/ Cardiac Resynchronization Therapy [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with Atrial fibrillation [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with prior hospitalization for HF [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with previous stroke [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with diabetes mellitus [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with Hypertension [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with Chronic kidney disease (CKD) [Baseline]
To evaluate clinical characteristics at baseline.
Duration of HF disease [Baseline]
To evaluate clinical characteristics at baseline.
Number of patients with pharmacological treatments for HF [throughout the study, approximately 3 years]
To evaluate the pharmacological treatments for HF during characterization and follow-up.

Secondary Outcome Measures

Number of patients with initial and final doses [throughout the study, approximately 3 years]
To evaluate the Sacubitril/Valsartan dosing pattern during follow-up
Number of patients with Non-maximum dose [throughout the study, approximately 3 years]
To evaluate the Sacubitril/Valsartan dosing pattern during follow-up
Time to maximal dose prescribed [throughout the study, approximately 3 years]
To evaluate the Sacubitril/Valsartan dosing pattern during follow-up
Number of patients with hospitalization HF-related [throughout the study, approximately 3 years]
To evaluate frequency of cardiovascular (CV) and non-CV death.
Number of patients with hospitalization related to other cardiovascular events [throughout the study, approximately 3 years]
To evaluate frequency of cardiovascular (CV) and non-CV death.
Number of patients with hospitalization related to non-CV cause [throughout the study, approximately 3 years]
To evaluate frequency of cardiovascular (CV) and non-CV death.
Number of patients with Percutaneous Coronary Intervention (PCI)/coronary artery bypass grafting (CABG) [throughout the study, approximately 3 years]
To evaluate frequency of cardiovascular (CV) and non-CV death.
Number of patients with Valvular intervention [throughout the study, approximately 3 years]
To evaluate frequency of cardiovascular (CV) and non-CV death.
Number of patients with Device implantation (ICD/CRT) [throughout the study, approximately 3 years]
To evaluate frequency of cardiovascular (CV) and non-CV death.
Number of patients with ER visits HF-related [throughout the study, approximately 3 years]
To evaluate frequency of cardiovascular (CV) and non-CV death.
Number of deaths [throughout the study, approximately 3 years]
To evaluate frequency of cardiovascular (CV) and non-CV death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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