Real World Experience in Heart Failure With Reduced Ejection Fraction (HFrEF) Patients Treated With sAc/vaL.
- Registration Number
- NCT05448872
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 924
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.
- Missing age or sex information.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Sacubitril/Valsartan Sacubitril/Valsartan Heart Failure (HF) patients treated with Sac/Val
- Primary Outcome Measures
Name Time Method Number of patients with Implanted prosthetic valve Baseline To evaluate clinical characteristics at baseline.
Gender Baseline To describe the demographics
Age Baseline To describe the demographics
Number of patients with Ischemic heart disease 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 previous stroke Baseline To evaluate clinical characteristics at baseline.
Number of patients with diabetes mellitus Baseline To evaluate clinical characteristics at baseline.
Duration of HF 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 prior hospitalization for HF Baseline To evaluate clinical characteristics at baseline.
Number of patients with Chronic kidney disease (CKD) 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 Hypertension 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
Name Time Method 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
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 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 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.
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 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 Valvular intervention throughout the study, approximately 3 years To evaluate frequency of cardiovascular (CV) and non-CV death.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇮🇹Trieste, Italy