Clinical Research Directory
Browse clinical research sites, groups, and studies.
The STOP-MED CTRCD Trial
Sponsor: Dinesh Thavendiranathan
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.
Official title: A Multi-Centre Non-Inferiority Randomized Controlled Trial of STOPping Cardiac MEDications in Patients With Normalized Cancer Therapy Related Cardiac Dysfunction: The STOP-MED CTRCD Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
335
Start Date
2024-03-04
Completion Date
2031-12
Last Updated
2026-03-30
Healthy Volunteers
No
Interventions
Stopping Heart Failure Medication(s)
This group will stop their heart failure medication(s) under the supervision of the study team.
Locations (14)
University of California, Los Angeles
Los Angeles, California, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
Cardio-Oncology Clinic, MAHI, University of Alberta Hospital
Edmonton, Alberta, Canada
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St Michael's Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
La Paz University Hospital
Madrid, Spain
Barts Health NHS Trust, University College London
London, London, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital)
London, United Kingdom