The STOP-MED CTRCD Trial
Start Date
3/4/2024
Completion Date
12/1/2031
Summary
Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump oxygenated blood to the body is compromised. It is a side effect of cancer therapy which can occur as commonly as in 1 in 5 patients. When this occurs, heart failure medications are started to protect the heart from progressing to heart failure. With early detection and treatment, heart function recovers to normal in \>80% of patients. Unfortunately, heart failure medications are associated with an undesirable long-term pill burden, financial costs, and side-effects (e.g., dizziness and fatigue). As a result, cancer survivors frequently ask if they can safely stop their heart failure medications once their heart function has returned to normal. Currently there is no scientific evidence in this area of Cardio-Oncology. To address this knowledge gap, the investigators have designed a randomized control trial to assess the safety of stopping heart failure medication in patients with CTRCD and recovered heart function. The investigators will enrol patients who have completed their cancer therapy and are on heart medications for their CTRCD, which has now normalized. The investigators will randomize patients with no other reasons to continue heart failure medications (e.g., kidney disease) to continuing or stopping their heart medications safely. All patients will undergo a cardiac MRI at baseline, 1 and 5 years with safety assessments at 6-8 weeks, 6 months and 3 and 5 years. The investigators will determine if stopping medications is non-inferior to continuing medications by counting the numbers of patients who develop heart dysfunction by 1 year in each group.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Stopping Heart Failure Medication(s)
Conditions
Locations
University of California, Los Angeles
Los Angeles, California 90095
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Baker Heart and Diabetes Institute
Melbourne, Victoria 3004
Australia
Cardio-Oncology Clinic, MAHI, University of Alberta Hospital
Edmonton, Alberta T6G 1C9
Canada
St. Boniface Hospital
Winnipeg, Manitoba R2H 2A6
Canada
Hamilton General Hospital
Hamilton, Ontario L8L 2X2
Canada
University of Ottawa Heart Institute
Ottawa, Ontario K1Y 4W7
Canada
St Michael's Hospital
Toronto, Ontario M5B 1W8
Canada
University Health Network
Toronto, Ontario M5G2C4
Canada
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw,
Poland
La Paz University Hospital
Madrid, 28046
Spain
Barts Health NHS Trust, University College London
London, London
United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
United Kingdom
Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital)
London,
United Kingdom