Menu
Not yet recruiting NCT07044700

Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection Fraction

— Observational Heart Failure of Reduced Ejection Fraction (HFrEF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Jardiance, non-SGLT2 inhibitors.
Who it may be relevant to
Registry conditions: Heart Failure of Reduced Ejection Fraction (HFrEF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Non-interventional Study of the Effectiveness and Safety of Jardiance in Patients With Heart Failure (HF) of Reduced Ejection Fraction (HFrEF) Compared to Guideline-recommended Non-SGLT2i Therapy Regimens in China: A Sub-study of the Postmarketing Study of Jardiance Among Patients With Heart Failure in China

Overview

This study is to provide the effectiveness and safety evidence in patients with heart failure of reduced ejection fraction (HFrEF) initiating Jardiance in real clinical practice in a larger Chinese population. The primary objective is to compare the risk of the composite outcome of cardiovascular (CV) death or hospitalisation for heart failure (HHF) in heart failure with reduced ejection fraction (HFrEF) patients initiating Jardiance with propensity score (PS) matched HFrEF patients initiating guideline-recommended non-sodium-glucose cotransporter-2 inhibitors (SGLT2i) medications (angiotensin-converting-enzyme inhibitors (ACEi)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), betablockers, and mineralocorticoid receptor antagonist (MRA)) in China, measured by the hazard ratio of the two groups.

Interventions

  • Drug Jardiance
    Jardiance
  • Drug non-SGLT2 inhibitors
    non-SGLT2 inhibitors

Primary outcome measures

  • Time from the index date to the first hospitalisation for heart failure (HHF) or cardiovascular (CV) death [Time frame: From the index date to the end date of each individual's follow-up, up to 3 years]
Secondary outcome measures (6)
  • Time from the index date to cardiovascular (CV) death [Time frame: From the index date to the end date of each individual's follow-up, up to 3 years]
  • Time from the index date to the first hospitalisation for heart failure (HHF) [Time frame: From the index date to the end date of each individual's follow-up, up to 3 years]
  • Total number of HHFs at 30 days after the index date [Time frame: At 30 days after the index date]
  • Total number of HHFs at 90 days after the index date [Time frame: At 90 days after the index date]
  • Total number of HHFs at 1 year after the index date [Time frame: At 1 year after the index date]
  • Time from the index date to all-cause death [Time frame: From the index date to the end date of each individual's follow-up, up to 3 years]

Eligibility criteria

Inclusion criteria

  • At least 18 years of age
  • Has at least 1 diagnosis of Heart Failure with Reduced Ejection Fraction (HFrEF) at baseline during the 6-month look-back period (on or prior to the index date)
  • Left Ventricular Ejection Fraction (LVEF) ≤40%
  • N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) >125pg/mL or Brain Natriuretic Peptide (BNP)≥35 pg/mL
  • New users of Jardiance or guideline-recommended non-Sodium-glucose Cotransporter-2 inhibitors (SGLT2i) medications (Angiotensin-converting-enzyme inhibitors (ACEi)/Angiotensin II Receptor Blocker (ARB)/ Angiotensin Receptor-neprilysin Inhibitor (ARNI), beta-blockers, and Mineralocorticoid Receptor Antagonist (MRA)) for HFrEF, who had not used the respective index drug during the look-back period
  • Baseline data during the look-back period or on the index date have been collected
  • Body mass index (BMI) <45 kg/m2

Exclusion criteria

  • Patients treated with any SGLT-2i during the look-back period
  • Patients treated with any other SGLT-2i on the index date

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Fuwai Hospital; National Center for Cardiovascular Diseases — Beijing

Identifiers

NCT: NCT07044700 · 1245-0291

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗