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Looking for participantsPhase4

The STOP-MED CTRCD Trial

Sponsor: Dinesh Thavendiranathan

NCT ID: NCT06183437

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Stopping Heart Failure Medication(s) (other)
How long the study runs
Study runs about 93 months (dates as stated)
About the drug or intervention
Stopping Heart Failure Medication(s) — other: This group will stop their heart failure medication(s) under the supervision of the study team.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at people whose heart muscle was weakened by cancer treatment (such as anthracyclines or HER2-targeted therapy) but has since recovered. The heart weakness, called cancer therapy-related cardiac dysfunction (CTRCD), got better after at least 6 months of heart failure medicines, and the heart pumping function is now back to normal. The study conditions listed are heart failure, cardiotoxicity, cardiac toxicity, antineoplastics toxicity, and cancer.

Who can take part

  • Adults aged 18 or over who finished cancer treatment (other than hormone therapy) more than 6 months ago, with no plans for further cancer treatment that could harm the heart
  • Past treatment with anthracyclines and/or HER2-targeted therapy
  • Previously had moderate to severe CTRCD (heart weakening) with no symptoms, diagnosed within 1 year of finishing the cancer treatment, using ESC/ICOS criteria
  • Currently taking at least 1 heart medicine started for CTRCD, for at least 6 months, with heart pumping function (LVEF) back to 50% or more on a recent echo (within 6 months), normal blood test results for NT-proBNP or BNP, and no heart failure symptoms
  • Heart scans (CMR, a type of MRI heart scan) at the start of the study must show normal pumping (LVEF of 50% or more) and normal heart chamber sizes

Who may not be able to

  • Any medical reason to keep taking heart failure medicines, such as ongoing heart failure symptoms, chronic kidney disease, vascular disease, or heart rhythm problems (note: people with high blood pressure before CTRCD keep their blood pressure medicine, as only medicines started for CTRCD are stopped)
  • Cannot have an MRI heart scan (for example, an older pacemaker that is not MRI-safe)
  • Has a cardiac device such as a defibrillator, CRT device, or pacemaker
  • Still taking water tablets (loop diuretics, such as furosemide) for heart failure
  • Life expectancy under 1 year or cancer that has spread (metastatic disease)
  • Past major heart event (heart attack, stroke, or hospital admission for heart failure) or heart procedure (such as stents or bypass surgery)
  • Problems with communication, understanding, or attending study visits, or unable to give informed consent

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Taking part involves study visits and heart scans including MRI heart scans (CMR), with heart medicines started for CTRCD being stopped; full visit schedule and study length are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
335
Started
2024-03-04
Last checked
2025-11

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • Phase4 - 335 participants
  • • Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump oxygenated blood to the body is compromised

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure

Where?

  • • London - Barts Health NHS Trust, University College London
  • • Liverpool - Liverpool Heart and Chest Hospital
  • • London - Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital)

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This 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.

Heart FailureCardiotoxicityCardiac ToxicityAntineoplastics ToxicityCancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2

What the study is looking for

  • ✓Adult patients (age ≥18 years) with cancer therapy completed more than 6 months prior (other than hormonal therapy)...
  • ✓Prior cancer therapy with anthracyclines and/ or HER2-treatment that targets specific changes in the cancer.
  • ✓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

Who cannot take part

  • ✗Contraindications for CMR (e.g., MRI non-compatible implanted pacemakers).
  • ✗Patients with heart 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 that has spread disease.
  • ✗Issues that prevent communication, understanding or presentation for study-related visits and inability to provide...
See the full 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 ≥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.

Where Is This Study? (3 UK sites)

Barts Health NHS Trust, University College London

London, United Kingdom

Recruiting
Site contact (verified)
Charlotte Manisty, MDPrincipal Investigator

Liverpool Heart and Chest Hospital

Liverpool L14 3PE, United Kingdom

Recruiting
Site contact (verified)
Rebecca Dobson, MDPrincipal Investigator

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

London, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Alexander Lyon, MDPrincipal Investigator
Alexander Lyon, MD44 20 7352 8121

How to Get in Touch

Paaladinesh Thavendiranathan, MD

Sponsor contact

CONTACT

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

Sadia Khan

Sponsor contact

CONTACT

437-522-6441 Sadia.Khan@uhn.ca
Data sourced from ClinicalTrials.gov · Last verified: 2025-11