An interventional study of Bisoprolol and Valsartan in Takotsubo Cardiomyopathy, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of Edinburgh · Not applicable, Interventional, and Other
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.
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.
63 studies on the registry are indexed under Takotsubo Cardiomyopathy; 26 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 24 interventional studies indexed under Takotsubo Cardiomyopathy.
Browse Takotsubo Cardiomyopathy studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive no medication.
Drug: No medications
Participants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Bisoprolol.
Drug: Bisoprolol
Participants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Valsartan.
Drug: Valsartan
Participants in this arm will have had a diagnosis of takotsubo cardiomyopathy more than 6 months ago. They will be randomised to receive Sacubitril/Valsartan first for a 3 month period then switch onto Dapaglifozin for 3 months with a 1 month wash out period in between.
Drug: sacubitril/ valsartan
Participants in this arm will have had a diagnosis of takotsubo cardiomyopathy more than 6 months ago. They will be randomised to receive Dapaglifozin first for a 3 month period then switch onto Sacubitril/Valsartan for 3 months with a 1 month wash out period in between.
Drug: Dapagliflozin (10mg Tab)
Healthy volunteers will not receive any intervention.
Participants will be randomised to receive Bisoprolol medication.
Participants will be randomised to receive Valsartan medication.
Drug pages: Sacubitril · Valsartan
Participants will be randomised to receive Sacubitril/Valsartan medication first.
Participants will be randomised to receive Dapaglifozin medication first.
Participants will be randomised to receive no study medication.
Left ventricular myocardial manganese uptake.
Time frame: 2 years
Assessing effects of renin-angiotensin system inhibition and beta-adrenoreceptor blockade on myocardial manganese uptake.
Time frame: 2 years
Assessing effects of angiotensin receptor/neprilysin inhibition and sodium-glucose co-transporter 2 inhibition on myocardial manganese uptake.
Time frame: 2 years
Assessing the effects of cardiovascular risk factors on myocardial manganese uptake.
Time frame: 2 years
Correlation of neurohumoral markers and myocardial manganese uptake.
Time frame: 2 years
Correlations between myocardial manganese uptake and self-reported symptoms and objective assessments of exercise capacity in Takotsubo Cardiomyopathy.
Time frame: 2 years
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
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Studies of the drugs tested here: Bisoprolol · Valsartan · Sacubitril · Dapagliflozin