pre-heart failure with preserved ejection fraction MedDRA version: 20.1 Level: LLT Classification code 10076396 Term: Heart failure with preserved ejection fraction System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Jardiance
Pharmaceutical Form: Tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Sponsors
University College Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged >40 years old with at least one cardiovascular risk factor(s) including: a. Hypertension b. Coronary artery disease c. Obesity d. Previous ischaemic stroke or TIA e. Peripheral vascular disease f. Hypercholesterolaemia g. Previous chemotherapy or radiotherapy to the chest 2) Not currently on SGLT-2i treatment 3) LAVI =29mL/m2 obtained by Doppler echocardiography 4) Are able and agree to Fitbit use and exercise prescription 5) Subjects must be able and willing to give written informed consent 6) Access to a smart phone 7) Non-diabetic Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Aged >85years old 2. Subjects with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption 3. Recent (within 3 months) acute myocardial infarction or stroke 4. Permanent or persistent Atrial Fibrillation 5. Any diabetes mellitus 6. Contraindication to SGLT-2i 7. Renal insufficiency with eGFR <20mL per min per 1.73m2. For those patients randomised to the substudy CMR with gadolinium, the eGFR cut off will be <30mL per min per 1.73m2. 8. A history of HF 9. Asymptomatic left ventricular systolic dysfunction as defined as LVEF <50% on most recent measurement. 10. Presence of haemodynamically significant mitral and /or aortic valve disease 11. Conditions that are expected to compromise survival over the study period 12. Concomitant participation in other interventional clinical trials 13. Subjects with contraindications to MRI or allergic reactions to MRI contrast dye (Dotarem) 14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drugs. 15. Women who are pregnant, breast-feeding, or women of childbearing potential not using estro-progestative oral or intra-uterine contraception or implants, or women using estro-progestative oral or intra-uterine contraception or implants but who consider stopping it during the planned duration of the study. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. (Contraception must be continued for one week following discontinuation of study drug). 16. Refusal to provide informed consent 17. Unable to exercise due to concomitant medical condition, such as severe arthritis, uncontrolled pain, severe airways disease or falls risk. 18. Cognitive impairment 19. Systolic blood pressure <100mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of Empagliflozin on diastolic dysfunction measured by LAVImax over 6 months in non-diabetic pre-HFPEF patients using CMR.;Secondary Objective: ?To assess the effect of Empagliflozin versus usual medical care on CMR left ventricular structure and function ?To assess the effect of Empagliflozin on Brain Natriuretic Peptide and eGFR ;Primary end point(s): Change in LAVI measured by CMR over 6 months;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in CMR LVMI between baseline and 6 months • Change in CMR LVESVi between baseline and 6 months • Change in CMR LVEDVi between baseline and 6 months • Change in CMR LVEF between baseline and 6 months. • Change in CMR e’ between baseline and 6 months. • Change in CMR LV myocardial strain (measured using feature tracking) between baseline and 6 months. • Change in CMR parameter LA myocardial strain (measured using feature tracking) between baseline and 6 months. • Change in serum BNP and eGFR from baseline to 6 months ;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Ireland
Contacts
Public ContactClinical Research Centre
University College Dublin
Outcome results
None listed