Recruiting

STOP-MED

Sponsor:

Dinesh Thavendiranathan

Code:

NCT06183437

Conditions

Heart Failure

Cardiotoxicity

Cardiac Toxicity

Antineoplastics Toxicity

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stopping Heart Failure Medication(s)

Study Details

Brief 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.

Conditions

Heart Failure

Cardiotoxicity

Cardiac Toxicity

Antineoplastics Toxicity

Cancer

Study ID

NCT06183437

Start date

Mar 4, 2024

Status verified date

Nov, 2025

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

335 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stop Group

This group will stop their heart failure medication(s) under the supervision of the study team. The investigators expect most participants in the STOP group to only be on beta-blockers (BB) and/or angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). The ACEi or ARB will be stopped first. The ACEi or ARB will be reduced by 50% every 7 days and stopped 7 days after 25% of maximal recommended dose for HF is reached. At this point (or at baseline if only on BB), the BB dose will be reduced by 50% every 7 days then stopped once 25% of the maximal dose is reached. Participants on 75% of the maximal dose will be reduced to 50% of the maximal dose before reducing by 50% every 7 days. Other HF medications will be stopped as follows: MRA: reduce by 50% every 7 days then stop once 50% of maximal dose is reached; SGLT2i: stopped without titration, ARNi: reduce by 50% every 7 days then stop once 25% of the maximal dose.

no intervention: Standard of Care Group

This group with continue with their heart failure medication(s) for at least 1 year.

Interventions

Stopping Heart Failure Medication(s)

This group will stop their heart failure medication(s) under the supervision of the study team.

Primary outcome measure

  • Cancer Therapy Related Cardiac Dysfunction Relapse [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Paaladinesh Thavendiranathan, MD

416-340-5326dinesh.thavendiranathan@uhn.ca

Sadia Khan

437-522-6441Sadia.Khan@uhn.ca

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Tomas Neilan, MD

TNEILAN@mgh.harvard.edu

Principal Investigator:

Tomas Neilan, MD

Cardio-Oncology Clinic, MAHI, University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 1C9

Principal Investigator:

Gabor Gyenes, MD

St. Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Principal Investigator:

Davinder Jassal, MD

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Principal Investigator:

Ian Paterson, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

Paaladinesh Thavendiranathan, MD

416-340-5326dinesh.thavendiranathan@uhn.ca

Principal Investigator:

Paaladinesh Thavendiranathan, MD

More Information

Sponsor

Dinesh Thavendiranathan

Last update posted

Jul 7, 2026

Last verified

Nov, 2025

Keywords

  • cancer therapy related cardiac dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dinesh Thavendiranathan on 2026-07-07.