NCT03753087

Brief 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) inhibitors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

November 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 16, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

2.9 years

First QC Date

November 21, 2018

Last Update Submit

January 10, 2022

Conditions

Heart Failure, DiastolicDiabetes Mellitus, Type 2

Keywords

HFHFpEFDMEmpagliflozinJardiance

Outcome Measures

Primary Outcomes (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

    24 weeks

Secondary Outcomes (18)

  • Change in left ventricular mass index (LVMI)

    24 weeks

  • Change in left atrial volume index (LAVI)

    24 weeks

  • Change in left atrial stiffness

    24 weeks

  • Change estimated pulmonary artery systolic pressure (PASP)

    24 weeks

  • Change in average e' velocity

    24 weeks

  • +13 more secondary outcomes

Study Arms (2)

Empagliflozin

EXPERIMENTAL

Patients will receive standard care for Heart Failure and Diabetes Mellitus + Empagliflozin 10mg once daily

Drug: Empagliflozin

Control

ACTIVE COMPARATOR

Patients will receive standard care for Heart Failure and Diabetes Mellitus with no SGLT-2 inhibitors

Other: Standard care

Interventions

EmpagliflozinDRUG

10 mg tablet

Empagliflozin
Standard careOTHER

Standard care with no SGLT-2 inhibitors

Control

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Medical Research Center for Cardiology

Moscow, 121552, Russia

Location

Related Publications (1)

  • 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.

    PMID: 40346546DERIVED

MeSH Terms

Conditions

Heart Failure, DiastolicDiabetes Mellitus, Type 2

Interventions

empagliflozinStandard of Care

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Anton Borisov, MD

    National Medical Research Center for Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 26, 2018

Study Start

January 16, 2019

Primary Completion

December 16, 2021

Study Completion

January 10, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Locations

RU(1)