Actively Recruiting
Manganese-enhanced Magnetic Resonance Imaging to Study Heart Changes and Medication Effects in Takotsubo Cardiomyopathy
Led by University of Edinburgh · Updated on 2026-03-24
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying takotsubo cardiomyopathy, also known as broken heart syndrome, a condition that affects heart muscle function often triggered by stress and mainly seen in women aged 50 to 74. This condition can resemble a heart attack and has serious risks including death during hospital stay and reduced long-term survival. The study aims to better understand the heart's physiological changes using manganese-enhanced MRI scans and to assess how different heart medications impact these changes. Participants are divided into groups based on how recently they were diagnosed. Those diagnosed within the last 3 months may receive Bisoprolol, Valsartan, or no medication. Those diagnosed more than 6 months ago will receive Sacubitril/Valsartan or Dapagliflozin for three months, then switch to the other medication for three months with a one-month break between treatments. Healthy volunteers will not receive any medication. The study involves a randomized assignment to these groups. During study visits held every few weeks to months, participants will undergo tests including manganese-enhanced MRI scans, echocardiograms, ECGs, walking tests, blood tests, clinical assessments, and symptom questionnaires. Researchers will measure manganese uptake in the heart muscle over two years and evaluate how medications and cardiovascular factors affect this uptake. The study includes safety monitoring and aims to correlate heart changes with symptoms and exercise capacity.
CONDITIONS
Brief Title
Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females over 18 years of age
- Clinical presentation of takotsubo cardiomyopathy
- Ability to provide formal consent
You will not qualify if you...
- Unable to tolerate or contraindicated for magnetic resonance imaging
- Renal failure with estimated glomerular filtration rate below 30 mL/min/1.73 m2
- Prior history of cardiomyopathy
- Current pregnancy
- Weight over 250 kg
- Severe asthma (for participants considered for Bisoprolol treatment)
- Type 1 diabetes mellitus (for participants considered for Dapagliflozin treatment)
- Significant hypotension
- Significant bradycardia (for participants considered for Bisoprolol treatment)
- Currently prescribed Digoxin
- Unable to provide formal consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 months including washout period
Participants with a recent diagnosis (less than 3 months ago) will be randomized to receive Bisoprolol, Valsartan, or no medication. Participants with a diagnosis more than 6 months ago will receive Sacubitril/Valsartan or Dapagliflozin for 3 months, followed by a 1-month washout, then switch to the alternative medication for 3 months. During treatment, participants will attend study visits every few weeks to months to undergo MRI scans, echocardiograms, ECGs, walking tests, blood tests, clinical assessments, and symptom questionnaires.
Study visits every few weeks to months during treatment
Duration - 2 years
Participants will be observed over 2 years to assess long-term heart muscle changes using manganese-enhanced MRI and other evaluations.
Follow-up visits as scheduled over 2 years
Trial Site Locations
Total: 1 location
1
University of Edinburgh
Edinburgh, United Kingdom
Actively Recruiting
Research Team
J
Jennifer Ramsay
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
6
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