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

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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: Sacubitril/Valsartan

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.

• Study Type: Observational
• Enrollment (Actual): 924

Contacts and Locations

Study Locations

• Italy
  • Trieste, Italy, 934125
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Heart Failure with reduced Ejection Fraction (HfrEF) patients treated with Sacubitril/Valsartan.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sacubitril/Valsartan; Heart Failure (HF) patients treated with Sac/Val	Drug: Sacubitril/Valsartan; HF patients treated with Sac/Val

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	To describe the demographics	Baseline
Gender	To describe the demographics	Baseline
Number of patients with Ischemic heart disease	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with PCI/CABG: Percutaneous coronary intervention/coronary artery bypass grafting	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with moderate or severe mitral or aortic valvulopathy	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with Implanted prosthetic valve	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with ICD/CRT, Implantable Cardioverter Defibrillator/ Cardiac Resynchronization Therapy	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with Atrial fibrillation	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with prior hospitalization for HF	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with previous stroke	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with diabetes mellitus	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with Hypertension	To evaluate clinical characteristics at baseline.	Baseline
Number of patients with Chronic kidney disease (CKD)	To evaluate clinical characteristics at baseline.	Baseline
Duration of HF disease	To evaluate clinical characteristics at baseline.	Baseline
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with initial and final doses	To evaluate the Sacubitril/Valsartan dosing pattern during follow-up	throughout the study, approximately 3 years
Number of patients with Non-maximum dose	To evaluate the Sacubitril/Valsartan dosing pattern during follow-up	throughout the study, approximately 3 years
Time to maximal dose prescribed	To evaluate the Sacubitril/Valsartan dosing pattern during follow-up	throughout the study, approximately 3 years
Number of patients with hospitalization HF-related	To evaluate frequency of cardiovascular (CV) and non-CV death.	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.	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.	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.	throughout the study, approximately 3 years
Number of patients with Valvular intervention	To evaluate frequency of cardiovascular (CV) and non-CV death.	throughout the study, approximately 3 years
Number of patients with Device implantation (ICD/CRT)	To evaluate frequency of cardiovascular (CV) and non-CV death.	throughout the study, approximately 3 years
Number of patients with ER visits HF-related	To evaluate frequency of cardiovascular (CV) and non-CV death.	throughout the study, approximately 3 years
Number of deaths	To evaluate frequency of cardiovascular (CV) and non-CV death.	throughout the study, approximately 3 years

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Results for CLCZ696BIT08 from the Novartis Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Heart failure,; Sacubitril/Valsartan; Drug utilization,; Real-world,
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: CLCZ696BIT08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO