NCT07047508

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jan 2028

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
2.6 years until next milestone

Study Start

First participant enrolled

January 31, 2028

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

June 24, 2025

Last Update Submit

February 12, 2026

Conditions

Heart FailurePreserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

  • Incidence of the composite outcome of HHF (the first HHF after the index date) or CV death

    HHF=Hospitalization for Heart Failure CV=cardiovascular

    up to 2.5 years

Secondary Outcomes (3)

  • Incidence of CV death

    up to 2.5 years

  • Incidence of the HHF (the first HHF after the index date)

    up to 2.5 years

  • Occurrence of death from any cause

    up to 2.5 years

Study Arms (1)

Heart failure and preserved ejection fraction patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chines patients with a heart failure and preserved ejection fraction (HFpEF) diagnosis who initiate Jardiance® after 1st of March 2023

You may qualify if:

  • 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

You may not qualify if:

  • Patients treated with any other sodium-glucose cotransporter-2 inhibitors (SGLT2i) on the index date or during the look-back period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Study Design

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

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 2, 2025

Study Start (Estimated)

January 31, 2028

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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