Real World Experience in HFrEF Patients Treated With sAc/vaL in ITaly
Overview
- Phase
- Not Applicable
- Intervention
- Sacubitril/Valsartan
- Conditions
- Heart Failure
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 924
- Locations
- 1
- Primary Endpoint
- Number of patients with Implanted prosthetic valve
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
- •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.
Arms & Interventions
Sacubitril/Valsartan
Heart Failure (HF) patients treated with Sac/Val
Intervention: Sacubitril/Valsartan
Outcomes
Primary Outcomes
Number of patients with Implanted prosthetic valve
Time Frame: Baseline
To evaluate clinical characteristics at baseline.
Gender
Time Frame: Baseline
To describe the demographics
Age
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 moderate or severe mitral or aortic valvulopathy
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.
Duration of HF 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 prior hospitalization for HF
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.
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 Hypertension
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.
Secondary Outcomes
- Number of patients with initial and final doses(throughout the study, approximately 3 years)
- Number of patients with Non-maximum dose(throughout the study, approximately 3 years)
- Number of patients with hospitalization HF-related(throughout the study, approximately 3 years)
- Number of patients with Percutaneous Coronary Intervention (PCI)/coronary artery bypass grafting (CABG)(throughout the study, approximately 3 years)
- Number of patients with Device implantation (ICD/CRT)(throughout the study, approximately 3 years)
- Number of patients with ER visits HF-related(throughout the study, approximately 3 years)
- Number of deaths(throughout the study, approximately 3 years)
- Time to maximal dose prescribed(throughout the study, approximately 3 years)
- Number of patients with hospitalization related to other cardiovascular events(throughout the study, approximately 3 years)
- Number of patients with hospitalization related to non-CV cause(throughout the study, approximately 3 years)
- Number of patients with Valvular intervention(throughout the study, approximately 3 years)