Takotsubo CardiomyopathyTAKO MEMRINCT07491718
Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy
A study testing Bisoprolol, Valsartan and sacubitril/ valsartan in people with Takotsubo Cardiomyopathy, run by University of Edinburgh at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Takotsubo Cardiomyopathy
- What is being tested?
- Bisoprolol, Valsartan and sacubitril/ valsartan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Aug 2025to 9 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Males and females >18 years of age
- Clinical presentation of takotsubo cardiomyopathy
- Have capacity to give formal consent
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Edinburgh
Edinburgh
Jennifer Ramsay, 01316501000, jramsay5@ed.ac.uk
Jennifer Ramsay
About this study
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.
Read the 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.
- Conditions
- Takotsubo Cardiomyopathy
- Being tested
- Bisoprolol, Valsartan, sacubitril/ valsartan, Dapagliflozin (10mg Tab), No medications
- Keywords
- Takotsubo, Broken heart syndrome, Stress cardiomyopathy, Manganese
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisoprololDrug
Participants will be randomised to receive Bisoprolol medication.
ValsartanDrug
Participants will be randomised to receive Valsartan medication.
sacubitril/ valsartanDrug
Participants will be randomised to receive Sacubitril/Valsartan medication first.
Dapagliflozin (10mg Tab)Drug
Participants will be randomised to receive Dapaglifozin medication first.
No medicationsDrug
Participants will be randomised to receive no study medication.
| Study group | Role | What they receive |
|---|---|---|
| Acute cohort - no medication | Placebo comparator | 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. Receives: Drug: No medications |
| Acute cohort - Bisoprolol | Active comparator | Participants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Bisoprolol. Receives: Drug: Bisoprolol |
| Acute cohort - Valsartan | Active comparator | Participants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Valsartan. Receives: Drug: Valsartan |
| Chronic cohort - Sacubitril/Valsartan first | Active comparator | 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. Receives: Drug: sacubitril/ valsartan |
| Chronic cohort - Dapaglifozin first | Active comparator | 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. Receives: Drug: Dapagliflozin (10mg Tab) |
| Healthy Volunteers | No intervention | Healthy volunteers will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular myocardial manganese uptake.
Measured: 2 years
Secondary outcomes (5)
Assessing effects of renin-angiotensin system inhibition and beta-adrenoreceptor blockade on myocardial manganese uptake.
Measured: 2 years
Assessing effects of angiotensin receptor/neprilysin inhibition and sodium-glucose co-transporter 2 inhibition on myocardial manganese uptake.
Measured: 2 years
Assessing the effects of cardiovascular risk factors on myocardial manganese uptake.
Measured: 2 years
Correlation of neurohumoral markers and myocardial manganese uptake.
Measured: 2 years
Correlations between myocardial manganese uptake and self-reported symptoms and objective assessments of exercise capacity in Takotsubo Cardiomyopathy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start8 Aug 2025
- Primary completion9 Aug 2028 (estimated)
- Study completion9 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takotsubo CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- This will be a prospective randomised open-label blinded endpoint (PROBE) study design with additional use of a cross-over design.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491718
- Sponsor's protocol ID
- 348948
- Other IDs
- PG/24/11930
- Acronym
- TAKO MEMRI
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07491718
- Acronym / sponsor ID
- TAKO MEMRI / 348948
- Conditions
- Takotsubo Cardiomyopathy
- Keywords
- Takotsubo, Broken heart syndrome, Stress cardiomyopathy, Manganese
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 9 Aug 2028 (estimated)
- Study completion
- 9 Aug 2028 (estimated)
- First posted
- 24 Mar 2026 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This will be a prospective randomised open-label blinded endpoint (PROBE) study design with additional use of a cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Acute cohort - no medication | Placebo comparator | Drug: No medicationsParticipants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive no medication. |
| Acute cohort - Bisoprolol | Active comparator | Drug: BisoprololParticipants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Bisoprolol. |
| Acute cohort - Valsartan | Active comparator | Drug: ValsartanParticipants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Valsartan. |
| Chronic cohort - Sacubitril/Valsartan first | Active comparator | Drug: sacubitril/ valsartanParticipants 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. |
| Chronic cohort - Dapaglifozin first | Active comparator | Drug: Dapagliflozin (10mg Tab)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. |
| Healthy Volunteers | No intervention | –Healthy volunteers will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females >18 years of age
- Clinical presentation of takotsubo cardiomyopathy
- Have capacity to give formal consent
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| BisoprololParticipants will be randomised to receive Bisoprolol medication. | Drug | Acute cohort - Bisoprolol |
| ValsartanParticipants will be randomised to receive Valsartan medication. | Drug | Acute cohort - Valsartan |
| sacubitril/ valsartanParticipants will be randomised to receive Sacubitril/Valsartan medication first. | Drug | Chronic cohort - Sacubitril/Valsartan first |
| Dapagliflozin (10mg Tab)Participants will be randomised to receive Dapaglifozin medication first. | Drug | Chronic cohort - Dapaglifozin first |
| No medicationsParticipants will be randomised to receive no study medication. | Drug | Acute cohort - no medication |
Primary outcome
Left ventricular myocardial manganese uptake.
Time frame: 2 years
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bisoprolol, Valsartan and sacubitril/ valsartan in people with Takotsubo Cardiomyopathy, 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 18 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Ramsay (01316501000, jramsay5@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular myocardial manganese uptake. (time frame: 2 years). 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 18 Sep 2026.