Stopping heart failure medications in cancer survivors with heart dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the safety of discontinuing heart failure medications in adult cancer survivors who have experienced cancer therapy-related cardiac dysfunction (CTRCD) and have shown recovery in heart function. The study involves a randomized control design to assess whether patients can safely stop their medications after their heart function has normalized. The goal is to address the lack of scientific evidence regarding the management of heart failure medications in this population, which could lead to reduced pill burden and side effects for patients. Participants must have completed cancer therapy and meet specific cardiac function criteria.

Why it matters

Who can join: the full rules

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 to severe CTRCD, defined using the ESC/ICOS criteria (MODERATE: ≥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 or SEVERE: new LVEF reduction to \<40% from normal baseline LVEF), 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 ≥50% by recently performed (≤6 months) echocardiogram, normal sex and age adjusted NT-proBNP or BNP ≤97.5th Centile, and no symptoms attributable to HF.
* Reference ranges for NT-proBNP and BNP by age and sex:

\<30 years: Female: NT-proBNP ≤196 pg/ml, BNP ≤55 pg/ml Male: NT-proBNP ≤104 pg/ml, BNP ≤29 pg/ml

30-39 years: Female: NT-proBNP ≤209 pg/ml, BNP ≤59 pg/ml Male: NT-proBNP ≤102 pg/ml, BNP ≤29 pg/ml

40-49 years: Female: NT-proBNP ≤233 pg/ml, BNP ≤65 pg/ml Male: NT-proBNP ≤137 pg/ml, BNP ≤38 pg/ml

50-59 years: Female: NT-proBNP ≤299 pg/ml, BNP ≤84 pg/ml Male: NT-proBNP ≤195 pg/ml, BNP ≤55 pg/ml

60-69 years: Female: NT-proBNP ≤399 pg/ml, BNP ≤112 pg/ml Male: NT-proBNP ≤333 pg/ml, BNP ≤93 pg/ml

70-79 years: Female: NT-proBNP ≤743 pg/ml, BNP ≤208 pg/ml Male: NT-proBNP ≤763 pg/ml, BNP ≤214 pg/ml

≥80 years: Female: NT-proBNP ≤2,704 pg/ml, BNP ≤757 pg/ml Male: NT-proBNP ≤6,792 pg/ml, BNP ≤1,902 pg/ml

* Confirmation of LVEF ≥50% 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.
* Normal Ventricular end-diastolic volumes by CMR as defined by the Society of Cardiac Magnetic Resonance 2025 update.

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 pre-CTRCD will continue their antihypertensive as only medication started for CTRCD will be ceased).
* Contraindications for CMR (e.g., MRI non-compatible implanted pacemakers).
* Patients with cardiac devices i.e. defibrillator, CRT, pacemaker, etc.
* 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.

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Baker Heart and Diabetes Institute
  Melbourne, Victoria, Australia Recruiting
• Cardio-Oncology Clinic, MAHI, University of Alberta Hospital
  Edmonton, Alberta, Canada Recruiting
• St. Boniface Hospital
  Winnipeg, Manitoba, Canada Recruiting
• University of Ottawa Heart Institute
  Ottawa, Ontario, Canada Recruiting
• University Health Network
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Paaladinesh Thavendiranathan, MD
• Email: dinesh.thavendiranathan@uhn.ca
• Phone: 416-340-5326

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.