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Completed

NCT Number: NCT03753087

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.

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Key information

Conditions

Heart Failure, Diastolic Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Medical Research Center for Cardiology

Moscow, 121552, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Additional exclusion criteria may apply

Treatment and study plan

Empagliflozin

Drug

10 mg tablet

Standard care

Other

Standard care with no SGLT-2 inhibitors

Primary outcomes

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

    Time frame: 24 weeks

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

Secondary outcomes

  1. Change in left ventricular mass index (LVMI)

    Time frame: 24 weeks

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

  2. Change in left atrial volume index (LAVI)

    Time frame: 24 weeks

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

  3. Change in left atrial stiffness

    Time frame: 24 weeks

    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

  4. Change estimated pulmonary artery systolic pressure (PASP)

    Time frame: 24 weeks

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

  5. Change in average e' velocity

    Time frame: 24 weeks

    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

  6. Change in average E/e' ratio

    Time frame: 24 weeks

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

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

    Time frame: 24 weeks

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

  8. Change in Cyclic guanosine monophosphate (cGMP)

    Time frame: 24 weeks

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

  9. Change in Endothelin 1 (ET-1)

    Time frame: 24 weeks

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

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

    Time frame: 24 weeks

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

  11. Change in ST2

    Time frame: 24 weeks

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

  12. Change in Galectin-3

    Time frame: 24 weeks

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

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

    Time frame: 24 weeks

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

  14. Change in Human Pentraxin 3 (PTX3)

    Time frame: 24 weeks

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

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

    Time frame: 24 weeks

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

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

    Time frame: 24 weeks

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

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

    Time frame: 24 weeks

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

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

    Time frame: 24 weeks

    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).

Sponsors and collaborators

Lead sponsor

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Other Gov

Collaborators

  • Ministry of Health, Russian Federation

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Nov 26, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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