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Heart FailurePhase 4STOP-MED CTRCDNCT06183437

The STOP-MED CTRCD Trial

A Phase 4 study testing Stopping Heart Failure Medication(s) in people with Heart Failure and Cardiotoxicity, run by Dinesh Thavendiranathan at 14 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Cardiotoxicity, Cardiac Toxicity
What is being tested?
Stopping Heart Failure Medication(s)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
335 participants
Where
14 sitesin 6 countries
Study dates
4 Mar 2024to Dec 2031
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Paaladinesh Thavendiranathan, MD contact

416-340-5326

dinesh.thavendiranathan@uhn.ca

14 sites in 6 countries

Canada6 sites, 6 recruiting
  • Cardio-Oncology Clinic, MAHI, University of Alberta Hospital

    Edmonton, Alberta, T6G 1C9

    Gabor Gyenes, MD

    Gabor Gyenes, MD

    Recruiting
  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

    Darryl Leong, MD

    Darryl Leong, MD

    Not yet recruiting
  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

    Ian Paterson, MD

    Ian Paterson, MD

    Recruiting
  • St Michael's Hospital

    Toronto, Ontario, M5B 1W8

    Kim Connelly, MD

    Kim Connelly, MD

    Not yet recruiting
  • University Health Network

    Toronto, Ontario, M5G2C4

    Paaladinesh Thavendiranathan, MD, 416-340-5326, dinesh.thavendiranathan@uhn.ca

    Paaladinesh Thavendiranathan, MD

    Recruiting
  • St. Boniface Hospital

    Winnipeg, Manitoba, R2H 2A6

    Davinder Jassal, MD

    Davinder Jassal, MD

    Recruiting

Other trials in Canada

United Kingdom3 sites, 3 recruiting
  • Liverpool Heart and Chest Hospital

    Liverpool, L14 3PE

    Rebecca Dobson, MD, 44 151 600 1616, Rebecca.Dobson@lhch.nhs.uk

    Rebecca Dobson, MD

    Recruiting
  • Barts Health NHS Trust, University College London

    London, London

    Charlotte Manisty, MD

    Charlotte Manisty, MD

    Recruiting
  • Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital)

    London

    Alexander Lyon, MD, 44 20 7352 8121

    Alexander Lyon, MD

    Not yet recruiting

Other trials in United Kingdom

United States2 sites, 2 recruiting
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Tomas Neilan, MD, TNEILAN@mgh.harvard.edu

    Tomas Neilan, MD

    Recruiting
  • University of California, Los Angeles

    Los Angeles, California, 90095

    Eric Yang, MD, 310-825-4321, EHYang@mednet.ucla.edu

    Eric Yang, MD

    Not yet recruiting

Other trials in United States

Australia1 site, 1 recruiting
  • Baker Heart and Diabetes Institute

    Melbourne, Victoria, 3004

    Tom Marwick, MD

    Tom Marwick, MD

    Recruiting

Other trials in Australia

Poland1 site, 1 recruiting
  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw

    Anna Borowiec, MD, 48 22 546 20 00, Anna.Borowiec@nio.gov.pl

    Anna Borowiec, MD

    Not yet recruiting

Other trials in Poland

Spain1 site, 1 recruiting
  • La Paz University Hospital

    Madrid, 28046

    Teresa Lopez Fernandez, MD, +34 917 27 70 00, teresa.lopez@salud.madrid.org

    Teresa Lopez Fernandez, MD

    Not yet recruiting

Other trials in Spain

About this study

Official 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

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.

Being tested
Stopping Heart Failure Medication(s)
Keywords
cancer therapy related cardiac dysfunction
Medical subject headings
Heart Failure, Cardiotoxicity, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stopping Heart Failure Medication(s)Other

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

Study groups in NCT06183437
Study groupRoleWhat they receive
Stop GroupExperimentalThis 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.
Receives: Other: Stopping Heart Failure Medication(s)
Standard of Care GroupNo interventionThis group with continue with their heart failure medication(s) for at least 1 year.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cancer Therapy Related Cardiac Dysfunction Relapse

    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.

    Measured: 1 year

Secondary outcomes (11)
  1. Dichotomized Primary Outcome

    The primary outcome stratified by baseline LVEF of 50-55% vs >55% .

    Measured: 1 year

  2. Moderate to severe CTRCD by 1 year

    The development of moderate to severe asymptomatic CTRCD as per the 2022 ESC guidelines by 1 year follow-up.

    Measured: 1 year

  3. Changes in cardiac magnetic resonance parameters

    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%.

    Measured: 1 year

  4. Left ventricular diastolic function

    Proportion of participants with new diastolic dysfunction or worsening diastolic function ≥1 grade by echocardiography between the two study groups.

    Measured: 1 year

  5. Non-adherence of heart failure medication(s)

    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.

    Measured: 1 year

  6. N-terminal pro B-type Natriuretic Peptide (NT-pro BNP)

    Doubling of NT-pro BNP compared to pre-HF therapy cessation between the two study groups.

    Measured: 1 year

  7. Changes in quality of life score

    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

    Measured: 1 year

  8. Cost effectiveness analysis

    We will compare the cost per quality adjusted life years between the two study groups.

    Measured: 1 year

  9. Proportion of participants developing the primary outcome by whether they developed moderate versus severe CTRCD at original diagnosis

    The proportion of those that develop the primary outcome stratified by CTRCD LVEF <40% or ≥40%

    Measured: 1 year

  10. Incidence of novel biomarkers and genomic factors that may determine the risk of developing the primary endpoint

    Incidence of cardiac, inflammatory, endothelial and other novel biomarkers and genomic factors that may determine the risk of developing the primary endpoint.

    Measured: 1 year

  11. Proportion of participants developing the primary outcome stratified by natriuretic peptides thresholds.

    Proportion of participants developing the primary outcome stratified by natriuretic peptides thresholds.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2023
  2. Study start4 Mar 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
335 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06183437
Sponsor's protocol ID
STOPMED-1
Acronym
STOP-MED CTRCD
Status last verified
Nov 2025
First submitted
13 Dec 2023
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stopping Heart Failure Medication(s) in people with Heart Failure and Cardiotoxicity, run by Dinesh Thavendiranathan at 14 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Canada, United Kingdom, United States, Australia, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Paaladinesh Thavendiranathan, MD (416-340-5326, dinesh.thavendiranathan@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer Therapy Related Cardiac Dysfunction Relapse (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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The STOP-MED CTRCD Trial (NCT06183437) | AzTrials