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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)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512062-34-00
Enrollment
100
Registered
2024-03-25
Start date
2023-08-30
Completion date
2025-01-16
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-Heart Failure (Non-diabetic)

Brief summary

Change in LAVImax measured by CMR over 6 months

Detailed description

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

Interventions

DRUGJardiance 10 mg film-coated tablets

Sponsors

University College Dublin, University College Dublin
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in LAVImax measured by CMR over 6 months—

Secondary

MeasureTime frame
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—

Countries

Ireland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026