Manganese MRI to image heart changes after takotsubo (broken heart) cardiomyopathy
Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy
NA · University of Edinburgh · NCT07491718
This project will test whether manganese-enhanced cardiac MRI, together with common heart medications, can reveal ongoing heart muscle changes in adults with takotsubo (broken heart) cardiomyopathy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh (other) |
| Locations | 1 site (Edinburgh) |
| Trial ID | NCT07491718 on ClinicalTrials.gov |
What this trial studies
Researchers will use manganese-enhanced cardiac MRI to measure manganese uptake in the heart as a marker of cellular-level changes after takotsubo cardiomyopathy. Participants are grouped by time since diagnosis: those diagnosed under 3 months may receive bisoprolol, valsartan, or no medication, while those diagnosed over 6 months may receive sacubitril/valsartan or dapagliflozin for three months. MRI scans and clinical tests will be compared before and after the medication period to see if drug treatment changes manganese uptake. The study aims to link commonly used heart medications with persistent imaging abnormalities following takotsubo.
Who should consider this trial
Good fit: Adults (18+) with a clinical diagnosis of takotsubo cardiomyopathy who can give informed consent, including those diagnosed within the past 3 months or more than 6 months ago, are the intended participants.
Not a fit: People who cannot undergo MRI, have severe renal failure, are pregnant, have prior cardiomyopathy, are on digoxin, or have contraindications to the study drugs (for example type 1 diabetes for dapagliflozin or severe asthma for bisoprolol) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could identify lingering heart muscle abnormalities after takotsubo and help guide use of existing heart medications to improve long-term outcomes.
How similar studies have performed: Previous work at the University of Edinburgh has shown manganese-enhanced MRI detects persistent changes after takotsubo, but using standard heart failure medications to modify those imaging findings is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females \>18 years of age * Clinical presentation of takotsubo cardiomyopathy * Have capacity to give formal consent Exclusion Criteria: * Unable to tolerate or contraindication to magnetic resonance imaging * Renal failure (estimated glomerular filtration rate \<30 mL/min/1.73 m2) - this would be assessed by performing a blood test * Prior history of cardiomyopathy * Current pregnancy * Weight greater than 250kg * Severe asthma for study 1 (given Bisoprolol is contraindicated in this condition) * Type 1 diabetes mellitus for study 2 (given Dapaglifozin is contraindicated in this population) * Significant hypotension (given the medications prescribed as part of the study can also cause hypotension as a side effect) * Significant bradycardia for study 1 (given Bisoprolol can exacerbate any pre-existing significant bradycardia) * Prescribed Digoxin (this medication interacts with the Manganese) * Unable to give formal consent
Where this trial is running
Edinburgh
- University of Edinburgh — Edinburgh, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Jennifer Ramsay
- Email: jramsay5@ed.ac.uk
- Phone: 01316501000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Takotsubo Cardiomyopathy, Takotsubo, Broken heart syndrome, Stress cardiomyopathy, Manganese