Heart FailureDAPA-MEMRINCT04591639
The DAPA-MEMRI Trial
A study testing Dapagliflozin 10 milligrams [Farxiga] in people with Heart Failure and Diabetic Cardiomyopathies, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Diabetic Cardiomyopathies
- What is being tested?
- Dapagliflozin 10 milligrams [Farxiga]
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Aug 2020to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Cross-sectional Study and a Double-blind Placebo Controlled Randomised Controlled Trial to Assess the Effect of Dapagliflozin on Myocardial Calcium-handling in Patients With Heart Failure- The DAPA-MEMRI Trial.
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.
Read more
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.
Read the detailed description
The study is designed to investigate the myocardial calcium handling in patients with heart failure with or without type 2 diabetes mellitus and if Dapagliflozin (study drug) improves the myocardial calcium handling in patients with heart failure and diabetes mellitus.
We propose to conduct this study in two parts.
- OBSERVATIONAL CROSS-SECTIONAL STUDY An observational cross-sectional study will be undertaken to compare myocardial calcium in patients with diabetes mellitus and normal left ventricular ejection fraction (n=20), patients with heart failure in the absence of diabetes mellitus (n=60), and patients with both diabetes mellitus and heart failure (n=60). They will be compared with healthy volunteers (n=20). There will be an initial meeting, where informed consent will be documented and a medical assessment including blood tests will be undertaken as well as an echocardiogram will be performed. Healthy volunteers will only undergo Manganese enhanced cardiac MRI scan. The other cohorts will undergo a gadolinium enhanced cardiac MRI scan on their first visit. On a subsequent visit, they will undergo 1 cardiac Manganese enhanced Manganese MRI scan (MEMRI) which lasts 45-60 minutes. Participants will be monitored with blood pressure and ECG monitoring throughout the MEMRI scan. Patients will be offered an anti-sickness medication if required following the MEMRI scan.
- RANDOMISED CONTROLLED TRIAL
We will undertake a randomised double-blind placebo controlled trial of patients with heart failure with (n=60) and without (n=60) type 2 diabetes mellitus. These participants would have been recruited as part of the observational study as described above from out-patient clinics at the Edinburgh Heart Centre. If all eligibility criteria are met, patients will be randomised to receive treatment with either Dapagliflozin 10 mg, or matched placebo, once daily for 6 months at a ratio of 1:1. Detailed clinical assessment including history and examination, blood sampling, electrocardiogram, echocardiogram and cardiac MRI will be collected at baseline, 1 and 6 months.
There will also be a 3 month safety visit after randomisation to record any adverse events.
- Conditions
- Heart Failure, Diabetic Cardiomyopathies
- Being tested
- Dapagliflozin 10 milligrams [Farxiga], Placebo
- Keywords
- Heart failure, Sodium glucose Co-transporter 2 inhibitor therapy, Manganese enhanced cardiac magnetic resonance imaging
- Medical subject headings
- Heart Failure, Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 milligrams [Farxiga]Drug
Patients with heart failure with or without type 2 diabetes will be either randomised to 10mg Dapagliflozin once daily or matched placebo.
PlaceboDrug
Patients with heart failure with or without type 2 diabetes will be either randomised to 10mg Dapagliflozin once daily or matched placebo.
| Study group | Role | What they receive |
|---|---|---|
| Patients with heart failure without type 2 diabetes | Other | 60 patients with heart failure without type 2 diabetes will be recruited and will either be randomised to placebo or Dapagliflozin after their baseline cardiac MRIs. They will have 2 cardiac MRIs (gadolinium and manganese enhanced) at baseline and further manganese enhanced cardiac MRI at 1 month post randomisation + gadolinium and manganese enhanced cardiac MRI at 6 months post randomisation. Receives: Drug: Dapagliflozin 10 milligrams [Farxiga]; Drug: Placebo |
| Patients with heart failure with type 2 diabetes | Other | 60 patients with heart failure with type 2 diabetes will be recruited and will either be randomised to placebo or Dapagliflozin after their baseline cardiac MRIs. They will have 2 cardiac MRIs (gadolinium and manganese enhanced) at baseline and further manganese enhanced cardiac MRI at 1 month post randomisation + gadolinium and manganese enhanced cardiac MRI at 6 months post randomisation. Receives: Drug: Dapagliflozin 10 milligrams [Farxiga]; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in myocardial T1 values with manganese enhanced cardiac MRI
Measured: 6 months
Secondary outcomes (11)
Left ventricular ejection fraction measured in percentage on cardiac MRI
Measured: 6 months
Left ventricular mass measured in grams on cardiac MRI
Measured: 6 months
Cardiac biomarkers like N-terminal pro B-type natriuretic peptide in nanogram per litre
Measured: 6 months
Markers of diabetes control including glucose in millimoles per litre
Measured: 6 months
Clinical measures such as heart rate in beats per minute
Measured: 6 months
Extracellular volume in percentage as per cardiac MRI measurements
Measured: 6 months
Global longitudinal strain in percentage as calculated on cardiac MRI
Measured: 6 months
Clinical measures such as body weight in Kilograms
Measured: 6 months
Clinical measures such as blood pressure in millimetres of mercury
Measured: 6 months
Cardiac biomarkers like high sensitivity cardiac troponin I in nanogram per litre
Measured: 6 months
Measures of glucose control like glycated haemoglobin (HbA1c) in millimoles per mole
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start19 Aug 2020
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The observational component of the study will have 4 cohort of participants (patients with type 2 diabetes without heart failure, patients with heart failure with or without diabetes and healthy volunteers) The randomised controlled trial component of the study will have 2 groups of patients - heart failure with or without type 2 diabetes
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591639
- Sponsor's protocol ID
- AC20006
- Acronym
- DAPA-MEMRI
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2020
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Cross-sectional Study and a Double-blind Placebo Controlled Randomised Controlled Trial to Assess the Effect of Dapagliflozin on Myocardial Calcium-handling in Patients With Heart Failure- The DAPA-MEMRI Trial.
- ClinicalTrials.gov ID
- NCT04591639
- Acronym / sponsor ID
- DAPA-MEMRI / AC20006
- Conditions
- Heart Failure, Diabetic Cardiomyopathies
- Keywords
- Heart failure, Sodium glucose Co-transporter 2 inhibitor therapy, Manganese enhanced cardiac magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- AstraZeneca, NHS Lothian
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is designed to investigate the myocardial calcium handling in patients with heart failure with or without type 2 diabetes mellitus and if Dapagliflozin (study drug) improves the myocardial calcium handling in patients with heart failure and diabetes mellitus.
We propose to conduct this study in two parts.
- OBSERVATIONAL CROSS-SECTIONAL STUDY An observational cross-sectional study will be undertaken to compare myocardial calcium in patients with diabetes mellitus and normal left ventricular ejection fraction (n=20), patients with heart failure in the absence of diabetes mellitus (n=60), and patients with both diabetes mellitus and heart failure (n=60). They will be compared with healthy volunteers (n=20). There will be an initial meeting, where informed consent will be documented and a medical assessment including blood tests will be undertaken as well as an echocardiogram will be performed. Healthy volunteers will only undergo Manganese enhanced cardiac MRI scan. The other cohorts will undergo a gadolinium enhanced cardiac MRI scan on their first visit. On a subsequent visit, they will undergo 1 cardiac Manganese enhanced Manganese MRI scan (MEMRI) which lasts 45-60 minutes. Participants will be monitored with blood pressure and ECG monitoring throughout the MEMRI scan. Patients will be offered an anti-sickness medication if required following the MEMRI scan.
- RANDOMISED CONTROLLED TRIAL
We will undertake a randomised double-blind placebo controlled trial of patients with heart failure with (n=60) and without (n=60) type 2 diabetes mellitus. These participants would have been recruited as part of the observational study as described above from out-patient clinics at the Edinburgh Heart Centre. If all eligibility criteria are met, patients will be randomised to receive treatment with either Dapagliflozin 10 mg, or matched placebo, once daily for 6 months at a ratio of 1:1. Detailed clinical assessment including history and examination, blood sampling, electrocardiogram, echocardiogram and cardiac MRI will be collected at baseline, 1 and 6 months.
There will also be a 3 month safety visit after randomisation to record any adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The observational component of the study will have 4 cohort of participants (patients with type 2 diabetes without heart failure, patients with heart failure with or without diabetes and healthy volunteers) The randomised controlled trial component of the study will have 2 groups of patients - heart failure with or without type 2 diabetes
| Arm | Type | Receives |
|---|---|---|
| Patients with heart failure without type 2 diabetes | Other | Drug: Dapagliflozin 10 milligrams [Farxiga], Drug: Placebo60 patients with heart failure without type 2 diabetes will be recruited and will either be randomised to placebo or Dapagliflozin after their baseline cardiac MRIs. They will have 2 cardiac MRIs (gadolinium and manganese enhanced) at baseline and further manganese enhanced cardiac MRI at 1 month post randomisation + gadolinium and manganese enhanced cardiac MRI at 6 months post randomisation. |
| Patients with heart failure with type 2 diabetes | Other | Drug: Dapagliflozin 10 milligrams [Farxiga], Drug: Placebo60 patients with heart failure with type 2 diabetes will be recruited and will either be randomised to placebo or Dapagliflozin after their baseline cardiac MRIs. They will have 2 cardiac MRIs (gadolinium and manganese enhanced) at baseline and further manganese enhanced cardiac MRI at 1 month post randomisation + gadolinium and manganese enhanced cardiac MRI at 6 months post randomisation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (31 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 milligrams [Farxiga]Patients with heart failure with or without type 2 diabetes will be either randomised to 10mg Dapagliflozin once daily or matched placebo. | Drug | Patients with heart failure with type 2 diabetes, Patients with heart failure without type 2 diabetes |
| PlaceboPatients with heart failure with or without type 2 diabetes will be either randomised to 10mg Dapagliflozin once daily or matched placebo. | Drug | Patients with heart failure with type 2 diabetes, Patients with heart failure without type 2 diabetes |
Primary outcome
Rate of change in myocardial T1 values with manganese enhanced cardiac MRI
Time frame: 6 months
11 secondary outcomes
Left ventricular ejection fraction measured in percentage on cardiac MRI
Time frame: 6 months
Left ventricular mass measured in grams on cardiac MRI
Time frame: 6 months
Cardiac biomarkers like N-terminal pro B-type natriuretic peptide in nanogram per litre
Time frame: 6 months
Markers of diabetes control including glucose in millimoles per litre
Time frame: 6 months
Clinical measures such as heart rate in beats per minute
Time frame: 6 months
Extracellular volume in percentage as per cardiac MRI measurements
Time frame: 6 months
Global longitudinal strain in percentage as calculated on cardiac MRI
Time frame: 6 months
Clinical measures such as body weight in Kilograms
Time frame: 6 months
Clinical measures such as blood pressure in millimetres of mercury
Time frame: 6 months
Cardiac biomarkers like high sensitivity cardiac troponin I in nanogram per litre
Time frame: 6 months
Measures of glucose control like glycated haemoglobin (HbA1c) in millimoles per mole
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dapagliflozin 10 milligrams [Farxiga] in people with Heart Failure and Diabetic Cardiomyopathies, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in myocardial T1 values with manganese enhanced cardiac MRI (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.