Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy
- Sponsor
- University of Edinburgh
- Study ID
- NCT07491718
- Status
- Recruiting
Conditions
- Takotsubo Cardiomyopathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Bisoprolol — DRUGParticipants will be randomised to receive Bisoprolol medication.
- Valsartan — DRUGParticipants will be randomised to receive Valsartan medication.
- sacubitril/ valsartan — DRUGParticipants will be randomised to receive Sacubitril/Valsartan medication first.
- Dapagliflozin (10mg Tab) — DRUGParticipants will be randomised to receive Dapaglifozin medication first.
- No medications — DRUGParticipants will be randomised to receive no study medication.
Study Details
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.
Key Dates
- Start date
- Aug 8, 2025
- Status verified
- Aug 2025
- Primary completion
- Aug 9, 2028
- Completion
- Aug 9, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Placebo Comparator: Acute cohort - no medicationParticipants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive no medication.
- Active Comparator: Acute cohort - BisoprololParticipants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Bisoprolol.
- Active Comparator: Acute cohort - ValsartanParticipants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Valsartan.
- Active Comparator: Chronic cohort - Sacubitril/Valsartan firstParticipants 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.
- Active Comparator: Chronic cohort - Dapaglifozin firstParticipants 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.
- No Intervention: Healthy VolunteersHealthy volunteers will not receive any intervention.
Primary Outcome Measure
Left ventricular myocardial manganese uptake. [ Time Frame: 2 years ]
Central Contacts
- Jennifer Ramsay01316501000
Related Studies
- Registry of Patients With Takotsubo SyndromeRecruiting · NYU Langone Health · New York, New York
- The Cedars-Sinai Smidt Heart Institute Takotsubo Registry & Proteomic StudyRecruiting · Cedars-Sinai Medical Center · Los Angeles, California
- Psychosocial Support for Patients With Takotsubo SyndromeRecruiting · Weill Medical College of Cornell University · New York, New York