The study is a cohort observational, retrospective, non-interventional study.
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 Type
OBSERVATIONAL
Enrollment
924
HF patients treated with Sac/Val
Novartis Investigative Site
Trieste, Italy
Age
To describe the demographics
Time frame: Baseline
Gender
To describe the demographics
Time frame: Baseline
Number of patients with Ischemic heart disease
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with PCI/CABG: Percutaneous coronary intervention/coronary artery bypass grafting
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with moderate or severe mitral or aortic valvulopathy
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with Implanted prosthetic valve
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with ICD/CRT, Implantable Cardioverter Defibrillator/ Cardiac Resynchronization Therapy
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with Atrial fibrillation
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with prior hospitalization for HF
To evaluate clinical characteristics at baseline.
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Time frame: Baseline
Number of patients with previous stroke
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with diabetes mellitus
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with Hypertension
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with Chronic kidney disease (CKD)
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Duration of HF disease
To evaluate clinical characteristics at baseline.
Time frame: Baseline
Number of patients with pharmacological treatments for HF
To evaluate the pharmacological treatments for HF during characterization and follow-up.
Time frame: throughout the study, approximately 3 years
Number of patients with initial and final doses
To evaluate the Sacubitril/Valsartan dosing pattern during follow-up
Time frame: throughout the study, approximately 3 years
Number of patients with Non-maximum dose
To evaluate the Sacubitril/Valsartan dosing pattern during follow-up
Time frame: throughout the study, approximately 3 years
Time to maximal dose prescribed
To evaluate the Sacubitril/Valsartan dosing pattern during follow-up
Time frame: throughout the study, approximately 3 years
Number of patients with hospitalization HF-related
To evaluate frequency of cardiovascular (CV) and non-CV death.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: throughout the study, approximately 3 years
Number of patients with Valvular intervention
To evaluate frequency of cardiovascular (CV) and non-CV death.
Time frame: throughout the study, approximately 3 years
Number of patients with Device implantation (ICD/CRT)
To evaluate frequency of cardiovascular (CV) and non-CV death.
Time frame: throughout the study, approximately 3 years
Number of patients with ER visits HF-related
To evaluate frequency of cardiovascular (CV) and non-CV death.
Time frame: throughout the study, approximately 3 years
Number of deaths
To evaluate frequency of cardiovascular (CV) and non-CV death.
Time frame: throughout the study, approximately 3 years