Stopping heart failure medications in cancer survivors with heart dysfunction
A Multi-Centre Non-Inferiority Randomized Controlled Trial of STOPping Cardiac MEDications in Patients With Normalized Cancer Therapy Related Cardiac Dysfunction: The STOP-MED CTRCD Trial
This study is testing if cancer survivors with improved heart function can safely stop taking their heart failure medications to see if it reduces their pill burden and side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 335 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Trial ID | NCT06183437 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult cancer survivors who completed their cancer therapy over six months ago and have recovered from moderate CTRCD.
Not a fit: Patients currently undergoing cancer treatment or those with ongoing symptoms of heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could allow cancer survivors to safely stop heart failure medications, reducing their long-term medication burden and associated side effects.
How similar studies have performed: While there is limited scientific evidence in this specific area, similar studies in cardio-oncology have shown promising results in managing heart function recovery.
Eligibility criteria
Show full inclusion / exclusion 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 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 ≥55% 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 ≥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 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 this trial is running
Los Angeles, California and 13 other locations
- University of California, Los Angeles — Los Angeles, California, United States (Not_yet_recruiting)
- 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 (Not_yet_recruiting)
- St. Boniface Hospital — Winnipeg, Manitoba, Canada (Recruiting)
- Hamilton General Hospital — Hamilton, Ontario, Canada (Not_yet_recruiting)
- University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
- St Michael's Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- Maria Sklodowska-Curie National Research Institute of Oncology — Warsaw, Poland (Not_yet_recruiting)
- La Paz University Hospital — Madrid, Spain (Not_yet_recruiting)
- Barts Health NHS Trust, University College London — London, London, United Kingdom (Recruiting)
- Liverpool Heart and Chest Hospital — Liverpool, United Kingdom (Not_yet_recruiting)
- Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital) — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Paaladinesh Thavendiranathan, MD
- Email: dinesh.thavendiranathan@uhn.ca
- Phone: 416-340-5326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.