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Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy

Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07491718
Acronym
TAKO MEMRI
Enrollment
100
Registered
2026-03-24
Start date
2025-08-08
Completion date
2028-08-09
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takotsubo Cardiomyopathy

Keywords

Takotsubo, Broken heart syndrome, Stress cardiomyopathy, Manganese

Brief summary

The goal of this research study is to further understand the physiological mechanisms involved in a heart condition called takotsubo cardiomyopathy, also known as broken heart syndrome. Furthermore, the investigators will be assessing the effects different cardiac medications have on these physiological mechanisms. This will be achieved by performing cardiac MRI scans using a special dye called manganese. Manganese uptake in the heart is altered in patients with takotsubo cardiomyopathy. The investigators will study the effects that different cardiac medications have on manganese uptake.

Detailed description

Takotsubo cardiomyopathy is a medical condition which presents similarly to a heart attack. It is usually caused by physical or emotional stress and typically affects women aged 50-74. It causes sudden severe impairment in heart muscle function, which was previously thought to get better in a matter of weeks. However, 1 in 10 patients will die in hospital and those that recover have substantially reduced long-term survival. There is no definitive treatment for takotsubo cardiomyopathy at present. Standard heart scans carried out in clinical care suggest that takotsubo cardiomyopathy gets better within a few weeks. However, patients don't always feel better at this stage. Researchers at the University of Edinburgh have previously demonstrated that performing an MRI scan of the heart using a special dye called manganese shows that changes in the heart muscle persist for months to years after the original diagnosis of takotsubo cardiomyopathy. The investigators propose to assess the effects of established heart failure therapy on patients with takotsubo cardiomyopathy, specifically the effects this has on manganese-enhanced MRI scans. Participants will be divided into two study groups based on the timing of their diagnoses. Participants with a recent diagnosis less than 3 months ago will be allocated to receive Bisoprolol, Valsartan or no medication. Participants with a diagnosis more than 6 months ago will be allocated to receive Sacubitril/Valsartan or Dapaglifozin for 3 months then will change to the alternative medication for 3 months with a 1-month wash-out period in between. Participants will attend for study visits every few weeks-months to assess the effects of the medication. At the study visits the participants will undergo a range of investigations including the manganese-enhanced MRI scan, echocardiogram, ECG, walking test and blood tests. Furthermore, participants will undergo a clinical assessment by the study doctor and be asked to complete a symptom questionnaire.

Interventions

DRUGBisoprolol

Participants will be randomised to receive Bisoprolol medication.

DRUGValsartan

Participants will be randomised to receive Valsartan medication.

Participants will be randomised to receive Sacubitril/Valsartan medication first.

Participants will be randomised to receive Dapaglifozin medication first.

DRUGNo medications

Participants will be randomised to receive no study medication.

Sponsors

University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

This will be a prospective randomised open-label blinded endpoint (PROBE) study design with additional use of a cross-over design.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Left ventricular myocardial manganese uptake.2 years

Secondary

MeasureTime frame
Assessing effects of renin-angiotensin system inhibition and beta-adrenoreceptor blockade on myocardial manganese uptake.2 years
Assessing effects of angiotensin receptor/neprilysin inhibition and sodium-glucose co-transporter 2 inhibition on myocardial manganese uptake.2 years
Assessing the effects of cardiovascular risk factors on myocardial manganese uptake.2 years
Correlation of neurohumoral markers and myocardial manganese uptake.2 years
Correlations between myocardial manganese uptake and self-reported symptoms and objective assessments of exercise capacity in Takotsubo Cardiomyopathy.2 years

Countries

United Kingdom

Contacts

CONTACTJennifer Ramsay
jramsay5@ed.ac.uk01316501000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026