Cardiomyopathy Trial, Recruiting NCT04591639 Sponsor: University of Edinburgh Condition: Cardiomyopathy
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Cardiomyopathy Trial, Recruiting

NCT04591639
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

People with heart failure (with or without type 2 diabetes):

  • Adults aged 18 or over
  • People who have had a diagnosis of heart failure with symptoms and reduced pumping function for at least 2 months
  • People whose heart's pumping capacity (ejection fraction) is 40% or less
  • People with an elevated level of a specific heart stress marker in their blood (NT-proBNP above 125 pg/mL)
  • Up to half of this group may also have type 2 diabetes that has been managed with stable treatment for 12 months or more

People with type 2 diabetes and no heart failure:

  • Adults aged 18 or over
  • People with a confirmed diagnosis of type 2 diabetes, based on blood sugar or HbA1c test results at the time of diagnosis
  • People whose diabetes has been managed with stable treatment for 12 months or more
  • People with a normal heart pumping function

Healthy volunteers:

  • Adults aged 18 or over
  • People with normal heart pumping function and normal blood sugar levels
  • People with no significant other health conditions

Who may not be able to join:

People with heart failure (with or without type 2 diabetes):

  • People who have taken a type of diabetes medication called an SGLT2 inhibitor within the past 8 weeks
  • People who have previously been unable to tolerate or are medically advised against taking an SGLT2 inhibitor
  • People who are unable to have an MRI scan for safety reasons (confirm with trial site)
  • People with severely reduced kidney function (eGFR below 30 mL/min/1.73m²)
  • People with type 1 diabetes
  • People with low blood pressure symptoms or a systolic blood pressure below 95 mmHg
  • People who have been hospitalised for heart failure, a heart attack, stroke, or heart procedure within the past 12 weeks
  • People with certain heart rhythm problems, including second or third degree heart block, or atrial fibrillation/flutter with a resting heart rate above 100 beats per minute
  • People whose heart failure is caused by specific heart muscle or valve conditions, including restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic obstructive cardiomyopathy, or uncorrected primary valve disease
  • People with the most severe stage of heart failure (New York Heart Association Grade IV)
  • People with significant liver function abnormalities
  • People currently taking digoxin, diltiazem, or verapamil

People with type 2 diabetes and no heart failure:

  • People with other major significant health conditions
  • People with a history of coronary artery disease or symptoms suggesting significant underlying heart disease
  • People who are unable to have an MRI scan for safety reasons (confirm with trial site)
  • People with moderate or severe kidney impairment (eGFR below 45 mL/min/1.73m²)
  • People who have taken an SGLT2 inhibitor at any time
  • People with low blood pressure symptoms or a systolic blood pressure below 95 mmHg
  • People with an abnormal ECG (heart tracing)
  • People with significant abnormalities in blood or biochemistry test results

Healthy volunteers:

  • People with significant cardiovascular disease
  • People with diabetes
  • People who have taken an SGLT2 inhibitor at any time
  • People who are unable to have an MRI scan for safety reasons (confirm with trial site)
  • People with moderate or severe kidney impairment (eGFR below 45 mL/min/1.73m²)
  • People with low blood pressure symptoms or a systolic blood pressure below 95 mmHg
  • People with an abnormal ECG (heart tracing)
  • People with significant abnormalities in blood or biochemistry test results

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 0131 650 1000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of Edinburgh
Registry
ClinicalTrials.gov
Start date
19 August 2020
Est. completion
28 July 2028

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Rate of change in myocardial T1 values with manganese enhanced cardiac MRI

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov