Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy

NCT07491718 | Recruiting

• 2 other identifiers: 348948PG/24/11930
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Takotsubo Cardiomyopathy

Keywords

Takotsubo; Broken heart syndrome; Stress cardiomyopathy; Manganese

Outcome Measures

Primary Outcomes (1)

• Left ventricular myocardial manganese uptake.

  2 years

Secondary Outcomes (5)

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

  2 years

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

  2 years

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

  2 years

• Correlation of neurohumoral markers and myocardial manganese uptake.

  2 years

• Correlations between myocardial manganese uptake and self-reported symptoms and objective assessments of exercise capacity in Takotsubo Cardiomyopathy.

  2 years

Study Arms (6)

Acute cohort - no medication

PLACEBO COMPARATOR

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.

Drug: No medications

Acute cohort - Bisoprolol

ACTIVE COMPARATOR

Participants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Bisoprolol.

Drug: Bisoprolol

Acute cohort - Valsartan

ACTIVE COMPARATOR

Participants in this arm will have had a diagnosis of takotsubo cardiomyopathy within the last 3 months and will be randomized to receive Valsartan.

Drug: Valsartan

Chronic cohort - Sacubitril/Valsartan first

ACTIVE COMPARATOR

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.

Drug: sacubitril/ valsartan

Chronic cohort - Dapaglifozin first

ACTIVE COMPARATOR

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.

Drug: Dapagliflozin (10mg Tab)

Healthy Volunteers

NO INTERVENTION

Healthy volunteers will not receive any intervention.

Interventions

Bisoprolol DRUG

Participants will be randomised to receive Bisoprolol medication.

Acute cohort - Bisoprolol

Valsartan DRUG

Participants will be randomised to receive Valsartan medication.

Acute cohort - Valsartan

sacubitril/ valsartan DRUG

Participants will be randomised to receive Sacubitril/Valsartan medication first.

Chronic cohort - Sacubitril/Valsartan first

Dapagliflozin (10mg Tab) DRUG

Participants will be randomised to receive Dapaglifozin medication first.

Chronic cohort - Dapaglifozin first

No medications DRUG

Participants will be randomised to receive no study medication.

Acute cohort - no medication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females \>18 years of age
• Clinical presentation of takotsubo cardiomyopathy
• Have capacity to give formal consent

You may not qualify if:

• 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
• Weight greater than 250kg
• Severe asthma for study 1 (given Bisoprolol is contraindicated in this condition)
• Type 1 diabetes mellitus for study 2 (given Dapaglifozin is contraindicated in this population)
• Significant hypotension (given the medications prescribed as part of the study can also cause hypotension as a side effect)
• Significant bradycardia for study 1 (given Bisoprolol can exacerbate any pre-existing significant bradycardia)
• Prescribed Digoxin (this medication interacts with the Manganese)
• Unable to give formal consent

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

University of Edinburgh

Edinburgh, United Kingdom

RECRUITING

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Interventions

Bisoprolol; Valsartan; sacubitril and valsartan sodium hydrate drug combination; dapagliflozin

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Central Study Contacts

Jennifer Ramsay

CONTACT

01316501000; jramsay5@ed.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a prospective randomised open-label blinded endpoint (PROBE) study design with additional use of a cross-over design.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: March 24, 2026
• Study Start: August 8, 2025
• Primary Completion (Estimated): August 9, 2028
• Study Completion (Estimated): August 9, 2028
• Last Updated: March 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)