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

NCT05448872 | Completed

• 1 other identifier: CLCZ696BIT08
• Study Type: observational
• Target: 924
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

Drug utilization,; Heart failure,; Real-world,; Sacubitril/Valsartan

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (11)

• 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

• Time to maximal dose prescribed

  throughout the study, approximately 3 years

• Number of patients with hospitalization HF-related

  throughout the study, approximately 3 years

• Number of patients with hospitalization related to other cardiovascular events

  throughout the study, approximately 3 years

Study Arms (1)

Sacubitril/Valsartan

Heart Failure (HF) patients treated with Sac/Val

Drug: Sacubitril/Valsartan

Interventions

Sacubitril/Valsartan DRUG

HF patients treated with Sac/Val

Sacubitril/Valsartan

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Missing age or sex information.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Trieste, 934125, Italy

Location

Related Links

• Results for CLCZ696BIT08 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 8, 2022
• Study Start: November 23, 2020
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)