Actively Recruiting
The STOP-MED CTRCD Trial
Led by Dinesh Thavendiranathan · Updated on 2026-03-30
335
Participants Needed
14
Research Sites
404 weeks
Total Duration
On this page
Sponsors
D
Dinesh Thavendiranathan
Lead Sponsor
U
Unity Health Toronto
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The STOP-MED CTRCD Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Completed cancer therapy more than 6 months ago, excluding hormonal therapy, with no planned further cancer treatments that could cause CTRCD
- Prior treatment with anthracyclines and/or HER2-targeted therapy
- History of moderate to severe asymptomatic CTRCD diagnosed within 1 year after cancer therapy
- Currently using at least one heart failure medication for CTRCD for at least 6 months
- Normal heart function with left ventricular ejection fraction (LVEF) of 55% or higher confirmed by recent echocardiogram and cardiac MRI
- Normal age- and sex-adjusted NT-proBNP or BNP levels
You will not qualify if you...
- Need to continue heart failure medications due to ongoing symptoms, chronic kidney disease, vascular disease, or heart rhythm problems
- Contraindications to cardiac MRI, such as having non-compatible implanted pacemakers
- Presence of cardiac devices like defibrillators, CRT, or pacemakers
- Current use of loop diuretics for heart failure
- Life expectancy less than 1 year or presence of metastatic cancer
- History of major cardiovascular events like heart attack, stroke, heart failure hospitalization, or heart procedures
- Conditions preventing study communication, understanding, or consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004
Actively Recruiting
4
Cardio-Oncology Clinic, MAHI, University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 1C9
Not Yet Recruiting
5
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Actively Recruiting
6
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Not Yet Recruiting
7
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Actively Recruiting
8
St Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Not Yet Recruiting
9
University Health Network
Toronto, Ontario, Canada, M5G2C4
Actively Recruiting
10
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
Not Yet Recruiting
11
La Paz University Hospital
Madrid, Spain, 28046
Not Yet Recruiting
12
Barts Health NHS Trust, University College London
London, London, United Kingdom
Actively Recruiting
13
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom, L14 3PE
Not Yet Recruiting
14
Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital)
London, United Kingdom
Not Yet Recruiting
Research Team
P
Paaladinesh Thavendiranathan, MD
CONTACT
S
Sadia Khan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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