Takotsubo cardiomyopathy Circulatory System
Conditions
Interventions
An online tool will randomly assign participants in the EVEREST Trial to either receive RAS inhibition (oral angiotensin-converting enzyme inhibitor (ACEi) or oral angiotensin II receptor blocker (ARB
Sponsors
University of Aberdeen
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Acute takotsubo cardiomyopathy within 6 months (either first episode or a recurrent episode) 2. Age =18 years 3. Able and willing to give informed consent and to participate in study procedures 4. Willing to have a pregnancy test for those of childbearing potential
Exclusion criteria
Exclusion criteria: 1. Current pregnancy or current breastfeeding, or female actively trying to become pregnant 2. Any significant disease/disorder which, in the investigator’s opinion, either puts the patient at risk because of study participation or may influence the results of the study or the patient's ability to participate in the study. 3. Mandated clinical indication for RASi (ACE/ARB) therapy (any class 1A ESC guideline recommendation) 4. Known intolerance to RASi (ACE/ARB) 5. Previous allocation of a randomisation code in the current study 6. People without capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary composite outcome (endpoint) is the time-to-first event from randomisation to a composite of all-cause death or hospitalisation for either heart failure, myocardial infarction, stroke or recurrent takotsubo cardiomyopathy. The primary endpoint will be collected via routine healthcare electronically linked data (NHS England (Digital), NHS Wales Informatics Service, Public Health Scotland, Health and Social Care (HSC) Business Services Organisation Information Technology Services (ITS) Northern Ireland) of specific codes as detailed in the Statistical Analysis Plan, routine data collection will be completed at the end of the study. Clinical outcomes will also be recorded by local study teams at 3 months and 1 year after randomisation and annually thereafter, via case note review. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time-to-first event of the individual components of the primary composite endpoint measured using data collected from routine healthcare electronically linked data and local study teams at one timepoint 2. Symptoms and quality of life measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), health status using the EQ-5D-5L, and anxiety, depression, fatigue and treatment measured using acceptability questionnaires; health care use will be collected by participant completed questionnaires at baseline, 30 days, 3months, 6 months, 12 months, and annually from the date of participant randomisation | — |
Countries
Scotland, United Kingdom
Outcome results
None listed