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RECRUITING
NCT06183437
PHASE4

The STOP-MED CTRCD Trial

Sponsor: Dinesh Thavendiranathan

View on ClinicalTrials.gov

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

OTHER

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