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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448872
• Other study ID #: CLCZ696BIT08
• Status: Completed
• Start date: November 23, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: November 2022
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is a cohort observational, retrospective, non-interventional study.

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 information / eligibility

• Status: Completed
• Enrollment: 924
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Sacubitril/Valsartan
HF patients treated with Sac/Val

Locations

Country	Name	City	State
Italy	Novartis Investigative Site	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	To describe the demographics	Baseline
Primary	Gender	To describe the demographics	Baseline
Primary	Number of patients with Ischemic heart disease	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with PCI/CABG: Percutaneous coronary intervention/coronary artery bypass grafting	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with moderate or severe mitral or aortic valvulopathy	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with Implanted prosthetic valve	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with ICD/CRT, Implantable Cardioverter Defibrillator/ Cardiac Resynchronization Therapy	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with Atrial fibrillation	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with prior hospitalization for HF	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with previous stroke	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with diabetes mellitus	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with Hypertension	To evaluate clinical characteristics at baseline.	Baseline
Primary	Number of patients with Chronic kidney disease (CKD)	To evaluate clinical characteristics at baseline.	Baseline
Primary	Duration of HF disease	To evaluate clinical characteristics at baseline.	Baseline
Primary	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	Number of patients with initial and final doses	To evaluate the Sacubitril/Valsartan dosing pattern during follow-up	throughout the study, approximately 3 years
Secondary	Number of patients with Non-maximum dose	To evaluate the Sacubitril/Valsartan dosing pattern during follow-up	throughout the study, approximately 3 years
Secondary	Time to maximal dose prescribed	To evaluate the Sacubitril/Valsartan dosing pattern during follow-up	throughout the study, approximately 3 years
Secondary	Number of patients with hospitalization HF-related	To evaluate frequency of cardiovascular (CV) and non-CV death.	throughout the study, approximately 3 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients with Valvular intervention	To evaluate frequency of cardiovascular (CV) and non-CV death.	throughout the study, approximately 3 years
Secondary	Number of patients with Device implantation (ICD/CRT)	To evaluate frequency of cardiovascular (CV) and non-CV death.	throughout the study, approximately 3 years
Secondary	Number of patients with ER visits HF-related	To evaluate frequency of cardiovascular (CV) and non-CV death.	throughout the study, approximately 3 years
Secondary	Number of deaths	To evaluate frequency of cardiovascular (CV) and non-CV death.	throughout the study, approximately 3 years

External Links

•   Results for CLCZ696BIT08 from the Novartis Clinical Trials Website