TAKO MEMRIEffects of Heart Failure Therapy on Manganese-Enhanced MRI Scans in Takotsubo Cardiomyopathy
This study aims to evaluate how heart failure therapy affects manganese-enhanced MRI scans, specifically focusing on the uptake of manganese by the left ventricular myocardium in individuals with Takotsubo Cardiomyopathy.
Bisoprolol
+ Valsartan
+ sacubitril/ valsartan
Cardiovascular Diseases+3
+ Heart Diseases
+ Cardiomyopathies
Other Study
Summary
Study start date: August 8, 2025
Actual date on which the first participant was enrolled.Takotsubo cardiomyopathy is a heart condition that often mimics a heart attack, typically triggered by physical or emotional stress. It predominantly affects women aged between 50 and 74. Despite initial beliefs that this condition improves within weeks, 1 in 10 patients may not survive hospitalization, and those who recover have reduced long-term survival rates. Currently, there is no definitive treatment for this condition. This study aims to understand the long-term effects of Takotsubo cardiomyopathy and evaluate the impact of existing heart failure therapies on patients. The importance lies in potentially improving care and addressing the current lack of effective treatments for this condition. Participants in this study will be divided into two groups based on when they were diagnosed. Those diagnosed less than 3 months ago will receive either Bisoprolol, Valsartan, or no medication. Participants diagnosed more than 6 months ago will receive Sacubitril/Valsartan or Dapaglifozin for 3 months, followed by a switch to the alternative medication for another 3 months, with a 1-month break in between. Participants will attend regular study visits to assess the effects of the medication. These visits include various tests such as a manganese-enhanced MRI scan, an echocardiogram, an ECG, a walking test, and blood tests. Additionally, participants will have a clinical assessment by a study doctor and will be asked to complete a symptom questionnaire. The primary outcome measured is the uptake of manganese by the left ventricular heart muscle.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.5 intervention groups are designated in this study
20% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorGroup IV
Active ComparatorGroup 5
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location