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Completed

NCT Number: NCT05448872

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Trieste, 934125, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

sacubitril/valsartan

Drug

HF patients treated with Sac/Val

Primary outcomes

  1. Age

    Time frame: Baseline

    To describe the demographics

  2. Gender

    Time frame: Baseline

    To describe the demographics

  3. Number of patients with Ischemic heart disease

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  4. Number of patients with PCI/CABG: Percutaneous coronary intervention/coronary artery bypass grafting

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  5. Number of patients with moderate or severe mitral or aortic valvulopathy

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  6. Number of patients with Implanted prosthetic valve

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  7. Number of patients with ICD/CRT, Implantable Cardioverter Defibrillator/ Cardiac Resynchronization Therapy

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  8. Number of patients with Atrial fibrillation

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  9. Number of patients with prior hospitalization for HF

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  10. Number of patients with previous stroke

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  11. Number of patients with diabetes mellitus

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  12. Number of patients with Hypertension

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  13. Number of patients with Chronic kidney disease (CKD)

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  14. Duration of HF disease

    Time frame: Baseline

    To evaluate clinical characteristics at baseline.

  15. Number of patients with pharmacological treatments for HF

    Time frame: throughout the study, approximately 3 years

    To evaluate the pharmacological treatments for HF during characterization and follow-up.

Secondary outcomes

  1. Number of patients with initial and final doses

    Time frame: throughout the study, approximately 3 years

    To evaluate the Sacubitril/Valsartan dosing pattern during follow-up

  2. Number of patients with Non-maximum dose

    Time frame: throughout the study, approximately 3 years

    To evaluate the Sacubitril/Valsartan dosing pattern during follow-up

  3. Time to maximal dose prescribed

    Time frame: throughout the study, approximately 3 years

    To evaluate the Sacubitril/Valsartan dosing pattern during follow-up

  4. Number of patients with hospitalization HF-related

    Time frame: throughout the study, approximately 3 years

    To evaluate frequency of cardiovascular (CV) and non-CV death.

  5. Number of patients with hospitalization related to other cardiovascular events

    Time frame: throughout the study, approximately 3 years

    To evaluate frequency of cardiovascular (CV) and non-CV death.

  6. Number of patients with hospitalization related to non-CV cause

    Time frame: throughout the study, approximately 3 years

    To evaluate frequency of cardiovascular (CV) and non-CV death.

  7. Number of patients with Percutaneous Coronary Intervention (PCI)/coronary artery bypass grafting (CABG)

    Time frame: throughout the study, approximately 3 years

    To evaluate frequency of cardiovascular (CV) and non-CV death.

  8. Number of patients with Valvular intervention

    Time frame: throughout the study, approximately 3 years

    To evaluate frequency of cardiovascular (CV) and non-CV death.

  9. Number of patients with Device implantation (ICD/CRT)

    Time frame: throughout the study, approximately 3 years

    To evaluate frequency of cardiovascular (CV) and non-CV death.

  10. Number of patients with ER visits HF-related

    Time frame: throughout the study, approximately 3 years

    To evaluate frequency of cardiovascular (CV) and non-CV death.

  11. Number of deaths

    Time frame: throughout the study, approximately 3 years

    To evaluate frequency of cardiovascular (CV) and non-CV death.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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