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NCT06183437 · ClinicalTrials.gov registry record · Phase 4
The STOP-MED CTRCD Trial
A Phase 4 study of Cancer and Heart Failure, sponsored by University Health Network, Toronto.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 335
- Enrollment target
- 10
- Study locations
NCT06183437: Recruiting Phase 4 study of Cancer and Heart Failure, sponsored by University Health Network, Toronto.
NCT06183437 is a Phase 4 study of Cancer and Heart Failure that is actively recruiting participants, run by University Health Network, Toronto. The registered enrollment target is 335 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (90% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06183437, a Phase 4 study of Cancer and Heart Failure, is actively recruiting participants, sponsored by University Health Network, Toronto.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 335 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Stopping Heart Failure Medication(s)
Study Locations (10)
Ontario
- Hamilton General Hospital - Hamilton
- University of Ottawa Heart Institute - Ottawa
- St Michael's Hospital - Toronto
- University Health Network - Toronto
Alberta
- Foothills Medical Centre - Calgary
- Edmonton Clinic Health Academy - Edmonton
Massachusetts
- Brigham and Women's Hospital - Boston
Victoria
- Baker Heart and Diabetes Institute - Melbourne
Manitoba
- St. Boniface Hospital - Winnipeg
Other
- Barts Health NHS Trust, University College London - London
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2024-03-04 |
| Est. Completion | 2031-12 |
| Phase | Phase 4 |
What NCT06183437 shows while recruiting
NCT06183437 is an interventional study that assigns participants to a tested intervention. The registered 335 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (90% lower).
The record links to 5 conditions, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which Stopping Heart Failure Medication(s) is the first listed.
NCT06183437 lists 10 locations in 6 states (Ontario, Alberta, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT06183437 about?
NCT06183437 is a clinical study titled "The STOP-MED CTRCD Trial". 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 fr...
What is the current status of trial NCT06183437?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 335 participants. The study started on 2024-03-04. Estimated completion is 2031-12.
What conditions does trial NCT06183437 study?
This clinical trial studies the following conditions: Cancer, Heart Failure, Cardiotoxicity, Cardiac Toxicity, Antineoplastics Toxicity.
What interventions are being tested in trial NCT06183437?
The interventions under investigation include: Stopping Heart Failure Medication(s) (OTHER).
Who is sponsoring clinical trial NCT06183437?
This trial is sponsored by University Health Network, Toronto, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06183437 being conducted?
This trial has 10 study locations across Massachusetts, Victoria, Alberta, Manitoba, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06183437's enrollment target sits among peer trials
335 170th of 615 higher than 446 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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