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

Study Overview
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Brief Summary
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The study is a cohort observational, retrospective, non-interventional study.

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: Sacubitril/Valsartan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sacubitril/Valsartan<br>Heart Failure (HF) patients treated with Sac/Val | Drug: Sacubitril/Valsartan<br>* HF patients treated with Sac/Val<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with initial and final doses | To evaluate the Sacubitril/Valsartan dosing pattern during follow-up | throughout the study, approximately 3 years | 
| Number of patients with Non-maximum dose | To evaluate the Sacubitril/Valsartan dosing pattern during follow-up | throughout the study, approximately 3 years | 
| Time to maximal dose prescribed | To evaluate the Sacubitril/Valsartan dosing pattern during follow-up | throughout the study, approximately 3 years | 
| Number of patients with hospitalization HF-related | To evaluate frequency of cardiovascular (CV) and non-CV death. | 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. | 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. | 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. | throughout the study, approximately 3 years | 
| Number of patients with Valvular intervention | To evaluate frequency of cardiovascular (CV) and non-CV death. | throughout the study, approximately 3 years | 
| Number of patients with Device implantation (ICD/CRT) | To evaluate frequency of cardiovascular (CV) and non-CV death. | throughout the study, approximately 3 years | 
| Number of patients with ER visits HF-related | To evaluate frequency of cardiovascular (CV) and non-CV death. | throughout the study, approximately 3 years | 
| Number of deaths | To evaluate frequency of cardiovascular (CV) and non-CV death. | throughout the study, approximately 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug utilization,, Heart failure,, Real-world,, Sacubitril/Valsartan