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RECRUITING Phase 4

The STOP-MED CTRCD Trial

NCT06183437 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 335 participants
Start Date 2024-03-04
Est. Completion 2031-12
Phase Phase 4

Sponsor

University Health Network, Toronto

67 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06183437

The ClinicalTrials.gov registry entry for NCT06183437 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 335 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University Health Network, Toronto, which has 67 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06183437 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Ontario, Alberta, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06183437?

The interventions under investigation include: Stopping Heart Failure Medication(s) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06183437?

This trial is sponsored by University Health Network, Toronto, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial