Heart Failure
Conditions
Keywords
Drug utilization,, Heart failure,, Real-world,, 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.
Interventions
DRUGSacubitril/Valsartan
HF patients treated with Sac/Val
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of patients with initial and final doses | throughout the study, approximately 3 years | To evaluate the Sacubitril/Valsartan dosing pattern during follow-up |
Countries
Italy
Outcome results
None listed