Heart Failure of Reduced Ejection Fraction (HFrEF)NCT07044700
Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection Fraction
An observational study of Heart Failure of Reduced Ejection Fraction (HFrEF), run by Boehringer Ingelheim at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure of Reduced Ejection Fraction (HFrEF)
- What is being tested?
- Jardiance and non-SGLT2 inhibitors
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2028to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with heart failure of reduced ejection fraction (HFrEF) included by the heart failure medical union of the national center for cardiovascular diseases (HFMU-NCCD). In the database, heart failure with reduced ejection fraction (HFrEF) is defined as left ventricular ejection fraction (LVEF) <40%.
Who may be able to join
- 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
Who cannot join
- Patients treated with any SGLT-2i during the look-back period
- Patients treated with any other SGLT-2i on the index date
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital; National Center for Cardiovascular Diseases
Beijing, 100037
About this study
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
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.
- Being tested
- Jardiance, non-SGLT2 inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JardianceDrug
Also called Empagliflozin
Jardiance
non-SGLT2 inhibitorsDrug
non-SGLT2 inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Patients initiating Jardiance | Initiation of Jardiance for heart failure of reduced ejection fraction (HFrEF) treatment after the launch of HFrEF indication in China Receives: Drug: Jardiance | |
| Patients initiating other non-SGLT2i medications (ACEi/ARB/ARNI, beta-blockers, and MRA) | Initiation of a different guideline-recommended non-sodium-glucose cotransporter-2 inhibitors (non-SGLT2i) medication class (angiotensin-converting-enzyme inhibitors (ACEi)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), betablockers, and mineralocorticoid receptor antagonist (MRA)) for HFrEF treatment, after the launch of HFrEF indication of Jardiance in China Receives: Drug: non-SGLT2 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from the index date to the first hospitalisation for heart failure (HHF) or cardiovascular (CV) death
Measured: From the index date to the end date of each individual's follow-up, up to 3 years
Secondary outcomes (6)
Time from the index date to cardiovascular (CV) death
Measured: 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)
Measured: 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
Measured: At 30 days after the index date
Total number of HHFs at 90 days after the index date
Measured: At 90 days after the index date
Total number of HHFs at 1 year after the index date
Measured: At 1 year after the index date
Time from the index date to all-cause death
Measured: From the index date to the end date of each individual's follow-up, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start31 Jan 2028 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure of Reduced Ejection Fraction (HFrEF)Studies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044700
- Sponsor's protocol ID
- 1245-0291
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07044700
- Acronym / sponsor ID
- 1245-0291
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2028 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients initiating Jardiance | – | Drug: JardianceInitiation of Jardiance for heart failure of reduced ejection fraction (HFrEF) treatment after the launch of HFrEF indication in China |
| Patients initiating other non-SGLT2i medications (ACEi/ARB/ARNI, beta-blockers, and MRA) | – | Drug: non-SGLT2 inhibitorsInitiation of a different guideline-recommended non-sodium-glucose cotransporter-2 inhibitors (non-SGLT2i) medication class (angiotensin-converting-enzyme inhibitors (ACEi)/angiotensin II receptor blocker (ARB)/angiotensin receptor-neprilysin inhibitor (ARNI), betablockers, and mineralocorticoid receptor antagonist (MRA)) for HFrEF treatment, after the launch of HFrEF indication of Jardiance in China |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with heart failure of reduced ejection fraction (HFrEF) included by the heart failure medical union of the national center for cardiovascular diseases (HFMU-NCCD). In the database, heart failure with reduced ejection fraction (HFrEF) is defined as left ventricular ejection fraction (LVEF) <40%.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Patients treated with any SGLT-2i during the look-back period
- Patients treated with any other SGLT-2i on the index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JardianceAlso: EmpagliflozinJardiance | Drug | Patients initiating Jardiance |
| non-SGLT2 inhibitorsnon-SGLT2 inhibitors | Drug | Patients initiating other non-SGLT2i medications (ACEi/ARB/ARNI, beta-blockers, and MRA) |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure of Reduced Ejection Fraction (HFrEF), run by Boehringer Ingelheim at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.