The STOP-MED CTRCD Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
Stopping Heart Failure Medication(s): This group will stop their heart failure medication(s) under the supervision of the study team.
Study 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
Primary outcome measure(s)
- Cancer Therapy Related Cardiac Dysfunction Relapse — 1 year
To compare the proportion of those that develop by 1 year of follow-up one or both of the following (i) left ventricular ejection fraction \<50% and an absolute decline of \>5% from baseline by cardiac magnetic resonance (CMR) (ii) new heart failure signs (at least two physical findings or one physical finding and one laboratory finding) AND symptoms (at least one) with the initiation of qualifying heart failure therapy.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | Not Yet Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| Baker Heart and Diabetes Institute | Melbourne | Victoria | Recruiting |
| Cardio-Oncology Clinic, MAHI, University of Alberta Hospital | Edmonton | Alberta | Recruiting |
| St. Boniface Hospital | Winnipeg | Manitoba | Recruiting |
| Hamilton General Hospital | Hamilton | Ontario | Not Yet Recruiting |
| University of Ottawa Heart Institute | Ottawa | Ontario | Recruiting |
| St Michael's Hospital | Toronto | Ontario | Not Yet Recruiting |
| University Health Network | Toronto | Ontario | Recruiting |
| Maria Sklodowska-Curie National Research Institute of Oncology | Warsaw | Poland | Not Yet Recruiting |
| La Paz University Hospital | Madrid | Spain | Not Yet Recruiting |
| Barts Health NHS Trust, University College London | London | London | Recruiting |
| Liverpool Heart and Chest Hospital | Liverpool | United Kingdom | Recruiting |
| Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital) | London | United Kingdom | Not Yet Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06183437 on ClinicalTrials.gov ↗ ← All trials in Spain