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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (3 UK sites)
Barts Health NHS Trust, University College London
London, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool L14 3PE, United Kingdom
Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital)
London, United Kingdom
How to Get in Touch
Paaladinesh Thavendiranathan, MD
Sponsor contactCONTACT
Sadia Khan
Sponsor contactCONTACT
