Heart Failure Clinical Trial

The STOP-MED CTRCD Trial

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, we have designed a randomized control trial to assess the safety of stopping heart failure medication in patients with CTRCD and recovered heart function. We will enrol patients who have completed their cancer therapy and are on heart medications for their CTRCD, which has now normalized. We 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 and 9 months and 3 and 5 years. We 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Adult patients (age ≥18 years) with cancer therapy completed more than 6 months prior (other than hormonal therapy) and no plan for further cancer treatments with potential risk for CTRCD.
Prior cancer therapy with anthracyclines and/ or HER2-targeted therapy.
Prior asymptomatic, moderate CTRCD, defined using the European Society of Cardiology criteria (≥10% drop in LVEF from baseline to 40% to 49.9% OR <10% drop to 40-49.9% with a reduction in GLS by >15% or new abnormal Troponin I/T or NT-proBNP), diagnosed within 1 year of completing potentially cardiotoxic cancer therapy.
Current use of ≥1 HF medication started for CTRCD for at least 6 months with LVEF ≥55% by recently performed (≤6 months) echocardiogram, normal NT-proBNP, and no symptoms attributable to HF.
Confirmation of LVEF ≥55% and normal volumes at baseline CMR (i.e., some patients recruited based on echocardiography, may be excluded if baseline CMR LVEF/volumes are not normal). This is included given that the primary outcome includes the use of CMR LVEF.

Exclusion Criteria:

Indication for continuation of HF medications i.e., ongoing HF symptoms, chronic kidney disease (CKD), vascular disease, atrial or ventricular arrythmias, other (note: participants with hypertension will be switched to other guideline-based antihypertensive therapy).
Contraindications for CMR (e.g., MRI non-compatible implanted pacemakers).
Patients with severe CTRCD defined as having a nadir LVEF <40% due to the known poor prognosis in these patients.
Continued use of loop diuretic therapy for heart failure purposes i.e., furosemide.
Life expectancy <1 year or metastatic disease.
Prior history of major cardiovascular event (defined as myocardial infarction, cerebral vascular event, admission for HF) or therapeutic cardiovascular procedure (e.g., percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG)).
Issues that prevent communication, understanding or presentation for study-related visits and inability to provide informed consent.

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

335

Study ID:

NCT06183437

Recruitment Status:

Recruiting

Sponsor:

University Health Network, Toronto

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There are 9 Locations for this study

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Brigham and Women's Hospital
Boston Massachusetts, 02115, United States More Info
Anju Nohria, MD
Contact
Anju Nohria, MD
Principal Investigator
Baker Heart and Diabetes Institute
Melbourne Victoria, 3004, Australia More Info
Tom Marwick, MD
Contact
Tom Marwick, MD
Principal Investigator
Foothills Medical Centre
Calgary Alberta, T2N 2, Canada More Info
James White, MD
Contact
James White, MD
Principal Investigator
Edmonton Clinic Health Academy
Edmonton Alberta, T6G 1, Canada More Info
Edith Pituskin, PhD
Contact
Edith Pituskin, PhD
Principal Investigator
St. Boniface Hospital
Winnipeg Manitoba, R2H 2, Canada More Info
Davinder Jassal, MD
Contact
Davinder Jassal, MD
Principal Investigator
Hamilton General Hospital
Hamilton Ontario, L8L 2, Canada More Info
Darryl Leong, MD
Contact
Darryl Leong, MD
Principal Investigator
University of Ottawa Heart Institute
Ottawa Ontario, K1Y 4, Canada More Info
Ian Paterson, MD
Contact
Ian Paterson, MD
Principal Investigator
St Michael's Hospital
Toronto Ontario, M5B 1, Canada More Info
Kim Connelly, MD
Contact
Kim Connelly, MD
Principal Investigator
University Health Network
Toronto Ontario, M5G2C, Canada More Info
Paaladinesh Thavendiranathan, MD
Contact
416-340-5326
[email protected]
Paaladinesh Thavendiranathan, MD
Principal Investigator
University College London
London , , United Kingdom More Info
Charlotte Manisty, MD
Contact
Charlotte Manisty, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

335

Study ID:

NCT06183437

Recruitment Status:

Recruiting

Sponsor:


University Health Network, Toronto

How clear is this clinincal trial information?

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