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)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University College Dublin

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

30 Aug 2023 → 16 Jan 2025

Decision date (initial)

2024-03-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

HeartBeat Trust (Ireland)

External identifiers

EU CT number

2024-512062-34-00

EudraCT number

2022-002650-48

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the impact of Empagliflozin on diastolic dysfunction measured by LAVImax over 6 months in non-diabetic, pre-HFPEF patients using CMR

Secondary objectives 2

1. To assess the effect of Empagliflozin versus usual medical care on CMR left ventricular structure and function
2. To assess the effect of Empagliflozin on Brain Natriuretic Peptide and eGFR

Conditions and MedDRA coding

Pre-Heart Failure (Non-diabetic)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

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

Exclusion criteria 19

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in LAVImax measured by CMR over 6 months

Secondary endpoints 8

1. Change in CMR LVMI between baseline and 6 months
2. Change in CMR LVESVi between baseline and 6 months
3. Change in CMR LVEDVi between baseline and 6 months
4. Change in CMR LVEF between baseline and 6 months.
5. Change in CMR e’ between baseline and 6 months.
6. Change in CMR LV myocardial strain (measured using feature tracking) between baseline and 6 months.
7. Change in CMR parameter LA myocardial strain (measured using feature tracking) between baseline and 6 months
8. Change in serum BNP and eGFR from baseline to 6 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University College Dublin

Sponsor organisation

University College Dublin

Address

Catherine Mcauley Centre, 21 Nelson Street, Phibsborough 21 Nelson Street Phibsborough

City

Dublin 7

Postcode

DUB LIN7

Country

Ireland

Scientific contact point

Organisation

University College Dublin

Contact name

Gráinne O'Reilly

Public contact point

Organisation

University College Dublin

Contact name

Gráinne O'Reilly

Third parties 2

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications