Can a diabetes drug rewire calcium in failing hearts?
NCT ID NCT04591639
First seen Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time
Summary
Researchers are testing whether dapagliflozin, an SGLT2 inhibitor, changes how heart muscle handles calcium in people with heart failure. The trial compares heart scans using a manganese-based contrast dye against placebo in patients with heart failure, with or without type 2 diabetes, as well as in people with diabetes alone and healthy volunteers. The goal is to see if this imaging method can reveal the drug's mechanism of benefit.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dapagliflozin, a drug that helps the kidneys remove sugar and salt
- What this could lead to
- If the manganese MRI tracks calcium changes reliably, doctors could use it to understand how SGLT2 inhibitors help heart failure and match treatments to patients.
- What could go wrong
- The trial is small and early, so it may not show a clear link between dapagliflozin and calcium handling. Manganese contrast is experimental and its long-term safety is still being studied.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
81 people
The number who actually took part.
- Started
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Aug 2020
- Finished
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Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patients with heart failure (with or without type 2 diabetes mellitus) * Aged over 18 years * Diagnosis of symptomatic reduced ejection fraction heart failure for at least 2 months * Left ventricular ejection fraction ≤40% * Elevated N-terminal pro B-type natriuretic peptide (\>125 pg/mL) * Clinical diagnosis of type 2 diabetes mellitus for 50% of patient population - on stable therapy for at least 12 months or more. Patients with Type 2 Diabetes Mellitus and no heart failure * Aged over 18 years * Clinical diagnosis of type 2 diabetes mellitus (diagnosed by either HbA1c of 48mmol/mol (6.5%) or greater or fasting plasma glucose level of 7mmol/L or greater at the time of diagnosis) \- on stable therapy for at least 12 months or more. * Normal left ventricular systolic ejection fraction Healthy Volunteers * Aged over 18 years * Normal left ventricular ejection fraction and glycaemia * No clinically significant co-morbid conditions Exclusion Criteria: Patients with heart failure (with or without type 2 diabetes mellitus) * Receiving an SGLT2 inhibitor within 8 weeks of enrolment * Previous intolerance of, or contraindication to, an SGLT2 inhibitor * Standard magnetic resonance imaging safety exclusions * Severe renal impairment (eGFR \<30millilitre/min. 1.73m2) * Type 1 diabetes mellitus * Symptomatic hypotension or systolic blood pressure \<95 mmHg * Recent (within 12 weeks) hospitalisation for heart failure, acute cardiovascular event (such as myocardial infarction or stroke) or coronary re-vascularisation. * 2nd or 3rd degree atrioventricular block Atrial fibrillation or flutter with poor ventricular rate control (\>100 /min) * Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease * New York Heart Association grade IV heart failure * Obstructive liver function testing abnormalities * Concomitant digoxin, diltiazem or verapamil therapy. Patients with type 2 diabetes mellitus and no heart failure * Other major clinically significant co-morbid conditions * History of ischaemic heart disease or present history suggestive of probable clinically significant underlying ischaemic heart disease * Standard magnetic resonance imaging safety exclusions * Moderate or severe renal impairment (eGFR \<45 mL/min. 1.73m2) * Receiving a SGLT2 inhibitor at any time * Symptomatic hypotension or systolic blood pressure \<95 mmHg * Abnormal electrocardiogram * Clinically significant abnormalities of clinical haematology or biochemistry measurements. Healthy Volunteers * Major or clinically significant cardiovascular disease * Diabetes mellitus * Receiving an SGLT2 inhibitor at any time * Standard magnetic resonance imaging safety exclusions * Moderate or severe renal impairment (eGFR \<45 mL/min. 1.73m2) * Symptomatic hypotension or systolic blood pressure \<95 mmHg * Abnormal electrocardiogram * Clinically significant abnormalities of clinical haematology or biochemistry measurements.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Edinburgh
Edinburgh, Scotland, United Kingdom
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Other studies related to the condition(s) this trial covers.
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