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The DAPA-MEMRI Trial

Study acronym: DAPA-MEMRI
StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial completed Final enrollment: 81 participants (planned 160) · Primary completion date changed from estimate of Jul 28, 2028 to Jan 1, 2025 · Eligibility criteria expanded, about 39 words · 2 more Show 5 more changesShow less
    • Final enrollment: 81 participants (planned 160)
    • Primary completion date changed from estimate of Jul 28, 2028 to Jan 1, 2025
    • Eligibility criteria expanded, about 39 words
    • Site details revised
    • Study description expanded, about 2 words
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Primary completion date: Aug 19, 2023 to Jul 28, 2028 Completion date: Aug 19, 2024 to Jul 28, 2028v2 Show 1 more changeShow less
    • Completion date: Aug 19, 2024 to Jul 28, 2028
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Diabetes mellitus is among the top 10 causes of death worldwide with an increasing incidence. Patients with diabetes are at risk of developing heart failure which is characterised by significant changes in the heart muscle including scarring and thickening. Contraction of the heart involves movement of calcium across the heart muscle and disruption of this process is an early change seen in heart failure. Recently, a drug therapy (SGLT2 inhibitor therapy) in patients with diabetes was shown to benefit patients with heart failure but the mechanisms of benefit are unknown. Our hypothesis is that calcium handling is altered in patients with either type 2 diabetes mellitus (T2DM) or heart failure and that SGLT2 inhibitors can improve this in heart failure irrespective of the presence of T2DM. Scanning the heart using magnetic resonance imaging (MRI) enables detailed assessment of its structure and function by using a new contrast 'dye' containing manganese that has shown advantages over traditional contrast. We plan to further test this new dye as it has the potential to track and quantify improvements in heart function over time and detect changes in calcium handling in the heart muscle, making it an ideal measure to identify the mechanisms of benefit from SGLT2 inhibitor therapy. The study population will comprise patients with heart failure with and without type 2 diabetes, patients with type 2 diabetes without heart failure and healthy volunteers. Baseline comparisons will be made between the four groups before progressing to the randomised controlled trial with heart failure patients only. Patients will have a clinical assessment and blood tests, electrocardiogram, echocardiogram and MRI of the heart at each visit. If successful, this study will give us significant insights into mechanisms of action of SGLT2 inhibitors in heart failure and will enable us to tailor specific treatments in heart failure patients.
Trial Details
NCT Number NCT04591639
Lead Sponsor University of Edinburgh
Collaborators: AstraZeneca, NHS Lothian
Conditions Heart Failure, Diabetic Cardiomyopathies
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov