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)
Key facts
- Where
- Dublin, ÍrországSee the site
- Phase
- 2. fázis
Where in Írország
- St Vincent's University HospitalDublin, ÍrországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University College Dublin
- Trial code
- EU 2024-512062-34-00
- Record updated
- 2024. március 25.
- Original description
To assess the impact of Empagliflozin on diastolic dysfunction measured by LAVImax over 6 months in non-diabetic, pre-HFPEF patients using CMRRead full original descriptionShow less
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)
To assess the impact of Empagliflozin on diastolic dysfunction measured by LAVImax over 6 months in non-diabetic, pre-HFPEF patients using CMR
Inclusion: 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.
Exclusion: 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; 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; 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; Aged >85years old; Refusal to provide informed consent; Systolic blood pressure <100mmHg; Permanent or persistent Atrial Fibrillation; Contraindication to SGLT-2i.