Heart FailureNCT07047508
Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure and Preserved Ejection Fraction
An observational study of Heart Failure and Preserved Ejection Fraction, run by Boehringer Ingelheim.
Trial summary
The main objective of the study is to describe the effectiveness and safety outcomes among Chinese hospitalized heart failure with preserved ejection fraction (HFpEF) patients initiating Jardiance® in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Preserved Ejection Fraction
- How many people
- 3,000 participants
- Where
- No sites listed yet
- 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: Chines patients with a heart failure and preserved ejection fraction (HFpEF) diagnosis who initiate Jardiance® after 1st of March 2023
Who may be able to join
- At least 18 years of age
- At least 6 months of data prior to the index date
- Left ventricular ejection fraction (LVEF) > 40 %
- N-terminal Pro-B-type natriuretic peptide (NT-proBNP) > 125 pg/mL or brain natriuretic peptide (BNP) ≥ 35 pg/mL
- At least 1 diagnosis of Heart failure with preserved ejection fraction (HFpEF) or Heart failure with mid-range ejection fraction (HFmrEF) or chronic heart failure (CHF) at baseline during the look-back period (on or prior to the index date)
- New users of Jardiance® (initiating Jardiance® on or after March 1st, 2023, and without any record of Jardiance® prescription during the look-back period)
- Body Mass Index (BMI) <45 kg/m2
Who cannot join
- -Patients treated with any other sodium-glucose cotransporter-2 inhibitors (SGLT2i) on the index date or during the look-back period
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Non-interventional Study of the Effectiveness and Safety Outcomes in Patients With Heart Failure and Preserved Ejection Fraction (HFpEF) Initiating Jardiance in China: A Sub-study of the Post-marketing Study of Jardiance Among Patients With Heart Failure in China
The main objective of the study is to describe the effectiveness and safety outcomes among Chinese hospitalized heart failure with preserved ejection fraction (HFpEF) patients initiating Jardiance® in the real-world setting.
- Conditions
- Heart Failure, Preserved Ejection Fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure and preserved ejection fraction patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the composite outcome of HHF (the first HHF after the index date) or CV death
HHF=Hospitalization for Heart Failure CV=cardiovascular
Measured: up to 2.5 years
Secondary outcomes (3)
Incidence of CV death
Measured: up to 2.5 years
Incidence of the HHF (the first HHF after the index date)
Measured: up to 2.5 years
Occurrence of death from any cause
Measured: up to 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 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 FailureStudies 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
- 3,000 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
- NCT07047508
- Sponsor's protocol ID
- 1245-0313
- Status last verified
- Sep 2026
- First submitted
- 24 Jun 2025
- Last updated
- 16 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study of the Effectiveness and Safety Outcomes in Patients With Heart Failure and Preserved Ejection Fraction (HFpEF) Initiating Jardiance in China: A Sub-study of the Post-marketing Study of Jardiance Among Patients With Heart Failure in China
- ClinicalTrials.gov ID
- NCT07047508
- Acronym / sponsor ID
- 1245-0313
- Conditions
- Heart Failure, Preserved Ejection Fraction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 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
- 2 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.
The main objective of the study is to describe the effectiveness and safety outcomes among Chinese hospitalized heart failure with preserved ejection fraction (HFpEF) patients initiating Jardiance® in the real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure and preserved ejection fraction patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chines patients with a heart failure and preserved ejection fraction (HFpEF) diagnosis who initiate Jardiance® after 1st of March 2023
Key inclusion criteria (7 listed)
- At least 18 years of age
- At least 6 months of data prior to the index date
- Left ventricular ejection fraction (LVEF) > 40 %
- N-terminal Pro-B-type natriuretic peptide (NT-proBNP) > 125 pg/mL or brain natriuretic peptide (BNP) ≥ 35 pg/mL
- At least 1 diagnosis of Heart failure with preserved ejection fraction (HFpEF) or Heart failure with mid-range ejection fraction (HFmrEF) or chronic heart failure (CHF) at baseline during the look-back period (on or prior to the index date)
Key exclusion criteria (1 listed)
- -Patients treated with any other sodium-glucose cotransporter-2 inhibitors (SGLT2i) on the index date or during the look-back period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of the composite outcome of HHF (the first HHF after the index date) or CV death
Time frame: up to 2.5 years
HHF=Hospitalization for Heart Failure CV=cardiovascular
3 secondary outcomes
Incidence of CV death
Time frame: up to 2.5 years
Incidence of the HHF (the first HHF after the index date)
Time frame: up to 2.5 years
Occurrence of death from any cause
Time frame: up to 2.5 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 16 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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Preserved Ejection Fraction, run by Boehringer Ingelheim.
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 1 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of the composite outcome of HHF (the first HHF after the index date) or CV death (time frame: up to 2.5 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 16 Sep 2026.