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Heart Failure, DiastolicPhase 4NCT03753087

Effects of Empagliflozin on Exercise Capacity and Left Ventricular Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction and Type-2 Diabetes Mellitus

A Phase 4 study testing Empagliflozin in people with Heart Failure, Diastolic and Diabetes Mellitus, Type 2, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients enrolled into the study will be randomly allocated either to Empagliflozin group or control group. In the Empagliflozin group patients will be receiving standard care + Empagliflozin 10 mg o.d., in the control group patients will be receiving standard care without sodium glucose contransporter 2 (SGLT2)… Read more about this study

Who is it for?
Ages 45 to 80 years
What is being tested?
Empagliflozin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteRussia
Study dates
16 Jan 2019to 10 Jan 2022
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 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females aged 45 to 80 years at screening
  • Diagnosis of type-2 diabetes mellitus with stable glucose-lowering background therapy for at least 12 weeks
  • HbA1c ≥ 6,5% and ≤ 10% at screening
  • Diagnosis of HFpEF which includes:
  • Symptoms ± signs (as defined in 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure)
  • Ejection fraction ≥ 50% (by Simpson)
  • Increased LV filling pressures at rest or during exercise determined by echocardiography (LV diastolic dysfunction grade II/III and/or positive diastolic stress test) [according to American Society of Echocardiography and European Association of Cardiovascular Imaging (ASE/EACVI) Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography, 2016]
  • Signed and dated informed consent

Who cannot join

  • Pretreatment with empagliflozin or other SGLT-2 inhibitor within the last 2 months
  • Type-1 diabetes mellitus
  • NYHA classification IV or acute decompensated heart failure at screening
  • Impaired renal function, defined as eGFR <30 ml/min/1.73 m² of body-surface-area (CKD-EPI)
  • Systolic blood pressure > 180 mmHg or < 90 mmHg
  • Permanent atrial flutter or atrial fibrillation
Show all 14Show fewer
  • Other conditions that may be responsible for impaired diastolic function such as hypertrophic/restrictive cardiomyopathy, constrictive pericarditis and etc.
  • Anemia (Hb < 100 g/l)
  • Myocardial infarction, coronary artery bypass graft surgery within the last 3 months
  • Stroke or TIA within the last 3 months
  • Indications of liver disease
  • Acute genital infection or urinary tract infection
  • Pregnancy
  • Additional exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • National Medical Research Center for Cardiology

    Moscow, 121552

Other trials in Russia

About this study

Official title: A Phase 4, Single-center, Randomized, Parallel Group Study to Assess Effects of Empagliflozin on Exercise Capacity and Left Ventricular Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction and Type-2 Diabetes Mellitus

Patients enrolled into the study will be randomly allocated either to Empagliflozin group or control group. In the Empagliflozin group patients will be receiving standard care + Empagliflozin 10 mg o.d., in the control group patients will be receiving standard care without sodium glucose contransporter 2 (SGLT2) inhibitors.

Being tested
Empagliflozin, Standard care
Keywords
HF, HFpEF, DM, Empagliflozin, Jardiance
Medical subject headings
Heart Failure, Diastolic, Diabetes Mellitus, Type 2

What participants receive

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

  • EmpagliflozinDrug

    10 mg tablet

  • Standard careOther

    Standard care with no SGLT-2 inhibitors

Study groups in NCT03753087
Study groupRoleWhat they receive
EmpagliflozinExperimentalPatients will receive standard care for Heart Failure and Diabetes Mellitus + Empagliflozin 10mg once daily
Receives: Drug: Empagliflozin
ControlActive comparatorPatients will receive standard care for Heart Failure and Diabetes Mellitus with no SGLT-2 inhibitors
Receives: Other: Standard care

What is being measured

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

  1. Change in 6-minute walking distance (6MWD)

    Difference in distance walked during 6-minute walking test (6MWT) between 24 weeks after baseline and at baseline

    Measured: 24 weeks

Secondary outcomes (18)

  1. Change in left ventricular mass index (LVMI)

    Difference in LVMI assessed by echocardiography between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  2. Change in left atrial volume index (LAVI)

    Difference in LAVI assessed by echocardiography between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  3. Change in left atrial stiffness

    Difference in left atrial stiffness assessed as a ratio of mitral E/e' ratio to left atrial strain s between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  4. Change estimated pulmonary artery systolic pressure (PASP)

    Difference in PASP assessed by echocardiography both at rest and during diastolic stress test (DST) between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  5. Change in average e' velocity

    Difference in average e' velocity assessed by echocardiography both at rest and during diastolic stress test (DST) between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  6. Change in average E/e' ratio

    Difference in average E/e' ratio assessed by echocardiography both at rest and during diastolic stress between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  7. Change in N-terminal pro b-type natriuretic peptide (NT-proBNP)

    Difference in NT-proBNP plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  8. Change in Cyclic guanosine monophosphate (cGMP)

    Difference in cGMP plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  9. Change in Endothelin 1 (ET-1)

    Difference in ET-1 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  10. Change in Growth/differentiation factor 15 (GDF-15)

    Difference in GDF-15 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  11. Change in ST2

    Difference in ST2 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  12. Change in Galectin-3

    Difference in Galectin-3 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  13. Change in carboxyterminal propeptide of type I collagen (PICP)

    Difference in PICP plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  14. Change in Human Pentraxin 3 (PTX3)

    Difference in PTX3 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  15. Change in high-sensitivity C-reactive protein (hsCRP)

    Difference in hsCRP plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  16. Change in Interleukin-6 (IL-6)

    Difference in IL-6 plasma levels between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  17. Change of New York Heart Association (NYHA) functional classification

    Difference in NYHA class between 24 weeks after baseline and at baseline

    Measured: 24 weeks

  18. Change in Minnesota Living With Heart Failure Questionnaire (MLHFQ) score

    Difference in MLHFQ score between 24 weeks after baseline and at baseline.

    The questionnaire is comprised of 21 important physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. After receiving brief standardized instructions, the patient marks a 0 (zero) to 5 scale to indicate how much each itemized adverse of heart failure has prevented the patient from living as he or she wanted to live during the past 4 weeks. The questionnaire is simply scored by summation of all 21 responses.

    Score ranges from 0 (best quality of life) to 105 (worst quality of life).

    Measured: 24 weeks

Timeline

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

  1. First posted26 Nov 2018
  2. Study start16 Jan 2019
  3. Primary completion16 Dec 2021
  4. Study completion10 Jan 2022

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03753087
Sponsor's protocol ID
2018-9-25
Status last verified
Jan 2022
First submitted
21 Nov 2018
Last updated
11 Jan 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ovchinnikov A, Potekhina A, Filatova A, Svirida O, Zherebchikova K, Ageev F, Belyavskiy E. Effects of empagliflozin on functional capacity, LV filling pressure, and cardiac reserves in patients with type 2 diabetes mellitus and heart failure with preserved ejection fraction: a randomized controlled open-label trial. Cardiovasc Diabetol. 2025 May 9;24(1):196. doi: 10.1186/s12933-025-02756-y.

    PubMed 40346546

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Empagliflozin in people with Heart Failure, Diastolic and Diabetes Mellitus, Type 2, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.

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 8 inclusion and 14 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 Russia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in 6-minute walking distance (6MWD) (time frame: 24 weeks). 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 NCT03753087, which also lists 1 linked publication.

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 11 Jan 2022.

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