At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Bisoprolol (drug), Valsartan (drug), sacubitril/ valsartan (drug), Dapagliflozin (10mg Tab) (drug)
- How long the study runs
- Study runs about 36 months (dates as stated)
- About the drug or intervention
- Bisoprolol — drug: Participants will be randomised to receive Bisoprolol medication. · Valsartan — drug: Participants will be randomised to receive Valsartan medication. · sacubitril/ valsartan — drug: Participants will be randomised to receive Sacubitril/Valsartan medication first. · Dapagliflozin (10mg Tab) — drug: Participants will be randomised to receive Dapaglifozin medication first. · No medications — drug: Participants will be randomised to receive no study medication.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2025-08-08
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for takotsubo cardiomyopathy
- • NA - 100 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with takotsubo cardiomyopathy
Where?
- • Edinburgh - University of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Males and females \>18 years of age
- ✓Clinical presentation of takotsubo cardiomyopathy
- ✓Have capacity to give formal consent
Who cannot take part
- ✗Unable to tolerate or safety concern to magnetic resonance imaging
- ✗kidney failure (estimated glomerular filtration rate \<30 mL/min/1.73 m2) - this would be assessed by performing a...
- ✗Prior history of cardiomyopathy
- ✗Current pregnancy
- ✗Weight greater than 250kg
See the full criteria
Where Is This Study? (1 UK site)
University of Edinburgh
Edinburgh, United Kingdom
How to Get in Touch
Jennifer Ramsay
Sponsor contactCONTACT
