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Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy

ConditionTakotsubo Cardiomyopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Edinburgh

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and females >18 years of age

Clinical presentation of takotsubo cardiomyopathy

Have capacity to give formal consent

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Acute cohort - no medicationPlacebo comparator 1 intervention
Group B: Acute cohort - BisoprololActive comparator 1 intervention
Group C: Acute cohort - ValsartanActive comparator 1 intervention
Group D: Chronic cohort - Sacubitril/Valsartan firstActive comparator 1 intervention
Group E: Chronic cohort - Dapaglifozin firstActive comparator 1 intervention
Group F: Healthy VolunteersNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Left ventricular myocardial manganese uptake.

Time frame
2 years

Secondary outcomes

1

Assessing effects of renin-angiotensin system inhibition and beta-adrenoreceptor blockade on myocardial manganese uptake.

Time frame
2 years
2

Assessing effects of angiotensin receptor/neprilysin inhibition and sodium-glucose co-transporter 2 inhibition on myocardial manganese uptake.

Time frame
2 years
3

Assessing the effects of cardiovascular risk factors on myocardial manganese uptake.

Time frame
2 years
4

Correlation of neurohumoral markers and myocardial manganese uptake.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Edinburgh

Lead sponsor

Source ClinicalTrials.gov
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