AzTrials
AzTrials

Heart FailurePhase 4NCT05600387

Empagliflozin on the Function of Left Atrium in Heart Failure With Mildly Reduced or Preserved Ejection Fraction

A Phase 4 study testing Empagliflozin 10 MG in people with Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Zhijun Sun at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The number of heart failure with mildly reduced or preserved ejection fraction gradually increases. SGLT2-i has been shown to reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or more . Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Empagliflozin 10 MG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
5 Nov 2022to Oct 2025
Phase
Phase 4
Are there results?
None posted in the registry

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

Who may be able to join

  • Age ≥ 18 years old, BMI18.5-27.9kg/m²
  • Meet the definition of chronic heart failure and an ejection fraction of 40% or more (according to 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure)
  • Elevated NT-proBNP levels of more than 300 pg/mL
  • Signed and dated written informed consent form

Who cannot join

  • Myocardial infarction,coronary artery bypass graft surgery, or other major cardiovascular surgery within 30 days after enrollment
  • Percutaneous coronary intervention ,coronary artery bypass graft surgery,cardiac resynchronization therapy, implantable cardioverter defibrillatoror or other cardiac surgeries within 90 days prior to enrollment
  • Atrial fibrillation or flutter
  • SGLT-2i using within 90 days prior to enrollment
  • Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease),cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), or known pericardial constriction
  • Acute decompensated heart failure.
Show all 15Show fewer
  • Moderate to severe valvular stenosis or regurgitation
  • Symptomatic hypotension with systolic pressure ≤ 90mmHg or uncontrolled hypertension using drugs with systolic blood pressure of ≥180 mmHg at randomization
  • Sever infectious diseases(e.g. Severe myocarditis, severe pneumonia, and severe urinary tract infection)
  • Chronic pulmonary disease requiring home oxygen, oral corticosteroid therapy or hospitalization for exacerbation within 12 months
  • Other significant co-morbid conditions(impaired renal function( an estimated glomerular filtration rate of <20 mL/min/1.73 m2), hepatic failure, malignant tumors, severe hematologic diseases, etc.)
  • Major surgery performed within 90 days prior to enrollment or major scheduled elective surgery within 90 days after enrollment(major according to the investigator's assessment,such as gastrointestinal surgery that might interfere with trial medication absorption or malignant tumors surgery)
  • Type 1 diabetes or history of ketoacidosis
  • Pregnancy
  • Completion within 90 days of a trial of another drug study. Receipt of any investigative treatment other than the study medications for this trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shengjing Hospital

    Shenyang, Liaoning, 110004

Other trials in China

About this study

The number of heart failure with mildly reduced or preserved ejection fraction gradually increases. SGLT2-i has been shown to reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or more . However,its effect on the function on left atrium in heart failure with mildly reduced or preserved ejection fraction is still unknown.

Read the detailed description

Heart failure with mildly reduced or preserved ejection fraction has become an important part of heart failure, the proportion is also gradually increased .Atrial fibrillation , as a common arrhythmia disease, is often caused by heart failure and aggravates the process of heart failure. It has been documented that in patients with heart failure and an ejection fraction more than 40%, it may have a higher incidence of atrial fibrillation.Heart failure and atrial fibrillation together increase the risk of stroke, hospitalization for heart failure, and all-cause death from heart failure.

SGLT-2 inhibitor (SGLT-2i) is a new metabolic drug, through a variety of mechanisms on cardiac metabolism, has been shown to reduce the risk of death and rehospitalization, and improve the health of patients with heart failure.But the effect on preventing arrhythmia in patients with heart failure is still unclear. Some studies have shown that SGLT-2i reduces the left atrial volume index and the left ventricular diastolic volume index compared with placebo and some have proved that the indicators of the function of left atrium, such as peak atrial longitudinal strain (PALS), peak atrial contraction strain (PACS), can effectively predict the occurrence of atrial fibrillation. The purpose of this study is to apply empagliflozin (a class of SGLT-2i) in heart failure patients with mildly reduced or preserved ejection fraction to measure the changes in the function of left atrium and thus verify its prevention and control effect on atrial fibrillation.

Being tested
Empagliflozin 10 MG
Keywords
Heart Failure, Empagliflozin, Function of left atrium
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empagliflozin 10 MGDrug

    subjects in Empagliflozin group take 10mg Empagliflozin per day

Study groups in NCT05600387
Study groupRoleWhat they receive
Empagliflozin groupExperimentalsubjects in Empagliflozin group take 10mg Empagliflozin 10mg per day
Receives: Drug: Empagliflozin 10 MG
Control groupNo interventionsubjects in Control group will not receive Empagliflozin or other sglt-2 inhibitors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change of peak atrial longitudinal strain during 6 months

    peak atrial longitudinal strain will be assessed using echocardiography

    Measured: 6 months

  2. change of peak atrial contraction strain during 6 months

    peak atrial contraction strain will be assessed using echocardiography

    Measured: 6 months

  3. change of left atrial conduit strain during 6 months

    left atrial conduit strain will be assessed using echocardiography

    Measured: 6 months

Secondary outcomes (14)

  1. change of left atrial volume index during 6 months

    left atrial volume index will be assessed using echocardiography

    Measured: 6 months

  2. change of E/A during 6 months

    E/A will be assessed using echocardiography，and it is defined as the ratio of peak early diastolic flow velocity and peak late diastolic flow velocity

    Measured: 6 months

  3. change of E/e'during 6 months

    E/e' will be assessed using echocardiography and it is defined as the ratio of peak early diastolic flow velocity and peak early diastolic mitral annular velocity

    Measured: 6 months

  4. change of left ventricular global longitudinal strain during 6 months

    left ventricular global longitudinal strain will be assessed using echocardiography

    Measured: 6 months

  5. change of left ventricular ejection fraction during 6 months

    left ventricular ejection fraction will be assessed using echocardiography

    Measured: 6 months

  6. peak atrial longitudinal strain in the sixth month

    peak atrial longitudinal strain will be assessed using echocardiography

    Measured: 6 months

  7. peak atrial contraction strain in the sixth month

    peak atrial contraction strain will be assessed using echocardiography

    Measured: 6 months

  8. left atrial conduit strain in the sixth month

    left atrial conduit strain will be assessed using echocardiography

    Measured: 6 months

  9. left atrial volume index in the sixth month

    left atrial volume index will be assessed using echocardiography

    Measured: 6 months

  10. E/A in the sixth month

    E/A will be assessed using echocardiography，and it is defined as the ratio of peak early diastolic flow velocity and peak late diastolic flow velocity

    Measured: 6 months

  11. E/e' in the sixth month

    E/e' will be assessed using echocardiography and it is defined as the ratio of peak early diastolic flow velocity and peak early diastolic mitral annular velocity

    Measured: 6 months

  12. left ventricular global longitudinal strain in the sixth month

    left ventricular global longitudinal strain will be assessed using echocardiography

    Measured: 6 months

  13. left ventricular ejection fraction in the sixth month

    left ventricular ejection fraction will be assessed using echocardiography

    Measured: 6 months

  14. new-onset atrial fibrillation in the sixth month

    new-onset atrial fibrillation is defined as follows:no atrial fibrillation at screening and electrocardiogram in the sixth month indicates atrial fibrillation

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study start5 Nov 2022
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05600387
Sponsor's protocol ID
2022PS1015K
Status last verified
Mar 2023
First submitted
21 Oct 2022
Last updated
7 Mar 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin 10 MG in people with Heart Failure and Heart Failure With Preserved Ejection Fraction, run by Zhijun Sun 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of peak atrial longitudinal strain during 6 months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05600387.

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 7 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in