RecruitingPhase 4NCT06183437

The STOP-MED CTRCD Trial

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


Sponsor

Dinesh Thavendiranathan

Enrollment

335 participants

Start Date

Mar 4, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study, called STOP-MED CTRCD, looks at whether it is safe for cancer survivors to stop heart-protective medications (like ACE inhibitors or beta-blockers) that were prescribed because their cancer treatment damaged their heart. Many cancer survivors are on these medications long-term even if their heart function has recovered, and this trial tests whether stopping them is safe. **You may be eligible if...** - You are 18 or older who finished cancer treatment (other than hormonal therapy) more than 6 months ago - Your prior treatment included anthracycline chemotherapy (e.g., doxorubicin) and/or HER2-targeted therapy - You previously developed asymptomatic moderate to severe heart function decline after treatment but your heart has since recovered - You are currently on heart-protective medications **You may NOT be eligible if...** - You still have active cancer or are receiving treatment with heart risk - You are symptomatic from heart failure - Your heart function has not recovered to a safe level - You have another reason your heart medications cannot be stopped Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStopping 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06183437


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