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 — 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.

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 medication
    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.
  • Active Comparator: Acute cohort - Bisoprolol
    Participants 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 - Valsartan
    Participants 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 first
    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.
  • Active Comparator: Chronic cohort - Dapaglifozin first
    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.
  • No Intervention: Healthy Volunteers
    Healthy volunteers will not receive any intervention.

Primary Outcome Measure

Left ventricular myocardial manganese uptake. [ Time Frame: 2 years ]

Central Contacts

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