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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06183437
Registration number
NCT06183437
Ethics application status
Date submitted
13/12/2023
Date registered
27/12/2023
Date last updated
10/06/2025
Titles & IDs
Public title
The STOP-MED CTRCD Trial
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Scientific title
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
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Secondary ID [1]
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STOPMED-1
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Universal Trial Number (UTN)
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Trial acronym
STOP-MED
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Cardiotoxicity
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Cardiac Toxicity
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Antineoplastics Toxicity
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Cancer
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Stopping Heart Failure Medication(s)
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.
Other interventions: Stopping Heart Failure Medication(s)
This group will stop their heart failure medication(s) under the supervision of the study team.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cancer Therapy Related Cardiac Dysfunction Relapse
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Assessment method [1]
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To compare the proportion of those that develop by 1 year of follow-up one or both of the following (i) left ventricular ejection fraction \<50% and an absolute decline of \>5% from baseline by cardiac magnetic resonance (CMR) (ii) new heart failure signs (at least two physical findings or one physical finding and one laboratory finding) AND symptoms (at least one) with the initiation of qualifying heart failure therapy.
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Changes in cardiac magnetic resonance parameters
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Assessment method [1]
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Differences between the two groups in the following measures. 1. Changes in CMR LVEF as a continuous parameter. 2. Proportion of participants with increased CMR indexed LV volumes by =10% to higher-than-normal limits. 3. Proportion of participants with decline in CMR LVEF to \<50% with a \>10% absolute fall compared to pre-HF medication withdrawal. 4. CMR peak systolic global longitudinal strain (GLS) worsening by \>15%.
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Timepoint [1]
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1 year
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Secondary outcome [2]
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Left ventricular diastolic function
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Assessment method [2]
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Proportion of participants with new diastolic dysfunction or worsening diastolic function =1 grade by echocardiography between the two study groups.
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Timepoint [2]
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1 year
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Secondary outcome [3]
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Non-adherence of heart failure medication(s)
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Assessment method [3]
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Proportion of participants with non-adherence of heart failure medication(s) by 1 year between the two study groups. Non-adherence is defined in the STOP group as the proportion of participants in whom successful cessation of all medications used to treat CTRCD was not possible or re-addition of the same medications used in that participant for HF was necessary for non-HF indications (e.g., palpitations). In the standard of care (SOC) group non-adherence is defined as the proportion of participants who stopped all HF medications used to treat CTRCD.
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Timepoint [3]
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1 year
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Secondary outcome [4]
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N-terminal pro B-type Natriuretic Peptide (NT-pro BNP)
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Assessment method [4]
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Doubling of NT-pro BNP compared to pre-HF therapy cessation between the two study groups.
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Timepoint [4]
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1 year
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Secondary outcome [5]
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Changes in quality of life score
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Assessment method [5]
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Difference in patient questionnaires scores between the two groups using the following patient questionnaires: 1. Kansas City Cardiomyopathy Questionnaire 2. Short Form (SF) Survey -36 3. EQ-5D-5L
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Timepoint [5]
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1 year
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Secondary outcome [6]
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Cost effectiveness analysis
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Assessment method [6]
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We will compare the cost per quality adjusted life years between the two study groups.
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Timepoint [6]
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1 year
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Secondary outcome [7]
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Proportion of participants developing the primary outcome by whether they developed moderate versus severe CTRCD at original diagnosis
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Assessment method [7]
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The proportion of those that develop the primary outcome stratified by CTRCD LVEF \<40% or =40%
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Timepoint [7]
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1 year
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Secondary outcome [8]
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Incidence of novel biomarkers and genomic factors that may determine the risk of developing the primary endpoint
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Assessment method [8]
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Incidence of cardiac, inflammatory, endothelial and other novel biomarkers and genomic factors that may determine the risk of developing the primary endpoint.
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Timepoint [8]
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1 year
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Secondary outcome [9]
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Proportion of participants developing the primary outcome stratified by natriuretic peptides thresholds.
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Assessment method [9]
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Proportion of participants developing the primary outcome stratified by natriuretic peptides thresholds.
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Timepoint [9]
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1 year
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/03/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2031
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Actual
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Sample size
Target
335
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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Country [2]
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Canada
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State/province [2]
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Alberta
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Canada
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State/province [3]
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Manitoba
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Canada
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State/province [4]
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Ontario
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Country [5]
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United Kingdom
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State/province [5]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Health Network, Toronto
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Unity Health Toronto
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Hamilton Health Sciences Corporation
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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St. Boniface Hospital
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Ottawa Heart Institute Research Corporation
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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University College London Hospitals
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Other collaborator category [6]
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Other
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Name [6]
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Alberta Health Services, Calgary
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Address [6]
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Other collaborator category [7]
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Other
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Name [7]
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Brigham and Women's Hospital
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Address [7]
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Other collaborator category [8]
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Other
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Name [8]
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Baker Heart and Diabetes Institute
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Address [8]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06183437
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Paaladinesh Thavendiranathan, MD
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Address
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Phone
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416-340-5326
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06183437
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