The impact of Empagliflozin on Left atrIal Volume and the feasibility of using Fitbit and mHealth to prescribe Exercise in non-diabetic Pre- Heart Failure (ELIVE pre-HF Study)

Prior treatment

• Concomitant participation in other interventional clinical trials
• 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)
• Unable to exercise due to concomitant medical condition, such as severe arthritis, uncontrolled pain, severe airways disease or falls risk.

Other illness

• Presence of haemodynamically significant mitral and /or aortic valve disease
• Conditions that are expected to compromise survival over the study period
• Subjects with contraindications to MRI or allergic reactions to MRI contrast dye (Dotarem)
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drugs.
• Cognitive impairment
• Recent (within 3 months) acute myocardial infarction or stroke
• Any diabetes mellitus
• A history of HF

Lab values

• Subjects with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
• 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 .
• Asymptomatic left ventricular systolic dysfunction as defined as LVEF <50% on most recent measurement.

Age

• Aged >85years old

Other

• Refusal to provide informed consent
• Systolic blood pressure <100mmHg
• Permanent or persistent Atrial Fibrillation
• Contraindication to SGLT-2i

• 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
• Not currently on SGLT-2i treatment
• LAVI ≥29mL/m2 obtained by Doppler echocardiography
• Are able and agree to Fitbit use and exercise prescription
• Subjects must be able and willing to give written informed consent
• Access to a smart phone
• Non-diabetic