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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

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ClinicalTrials.gov Identifier: NCT03753087
Recruitment Status : Recruiting
First Posted : November 26, 2018
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
Ministry of Health of the Russian Federation
Information provided by (Responsible Party):
Anton Borisov, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Diastolic Diabetes Mellitus, Type 2 Drug: Empagliflozin Other: Standard care Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Empagliflozin
Patients will receive standard care for Heart Failure and Diabetes Mellitus + Empagliflozin 10mg once daily
Drug: Empagliflozin
10 mg tablet

Active Comparator: Control
Patients will receive standard care for Heart Failure and Diabetes Mellitus with no SGLT-2 inhibitors
Other: Standard care
Standard care with no SGLT-2 inhibitors




Primary Outcome Measures :
  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 Outcome Measures :
  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).




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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females aged 45 to 80 years at screening
  2. Diagnosis of type-2 diabetes mellitus with stable glucose-lowering background therapy for at least 12 weeks
  3. HbA1c ≥ 6,5% and ≤ 10% at screening
  4. 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]
  5. Signed and dated informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753087


Contacts
Contact: Fail Ageev, MD, PhD +74954146612 ftageev@gmail.com
Contact: Artem Ovchinnikov, MD, PhD artcardio@mail.ru

Locations
Russian Federation
National Medical Research Center for Cardiology Recruiting
Moscow, Russian Federation, 121552
Contact: Anton Borisov, MD       AntonBorisovMD@gmail.com   
Sponsors and Collaborators
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Ministry of Health of the Russian Federation
Investigators
Principal Investigator: Anton Borisov, MD National Medical Research Center for Cardiology

Responsible Party: Anton Borisov, Principal Investigator, MD, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
ClinicalTrials.gov Identifier: NCT03753087     History of Changes
Other Study ID Numbers: 2018-9-25
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Anton Borisov, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation:
HF
HFpEF
DM
Empagliflozin
Jardiance

Additional relevant MeSH terms:
Empagliflozin
Diabetes Mellitus
Heart Failure
Diabetes Mellitus, Type 2
Heart Failure, Diastolic
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Hypoglycemic Agents
Physiological Effects of Drugs