A Phase 4 interventional study of Stopping Heart Failure Medication(s) in Heart Failure, Cardiotoxicity and Cardiac Toxicity, sponsored by Dinesh Thavendiranathan. Recruiting at 14 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Dinesh Thavendiranathan · Phase 4, Interventional, and Treatment
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 335 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Dinesh Thavendiranathan as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
\<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
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Stopping Heart Failure Medication(s)
This group with continue with their heart failure medication(s) for at least 1 year.
This group will stop their heart failure medication(s) under the supervision of the study team.
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.
Time frame: 1 year
Dichotomized Primary Outcome
The primary outcome stratified by baseline LVEF of 50-55% vs \>55% .
Time frame: 1 year
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.
Time frame: 1 year
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%.
Time frame: 1 year
Left ventricular diastolic function
Proportion of participants with new diastolic dysfunction or worsening diastolic function ≥1 grade by echocardiography between the two study groups.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
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
Time frame: 1 year
Cost effectiveness analysis
We will compare the cost per quality adjusted life years between the two study groups.
Time frame: 1 year
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%
Time frame: 1 year
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.
Time frame: 1 year
Proportion of participants developing the primary outcome stratified by natriuretic peptides thresholds.
Proportion of participants developing the primary outcome stratified by natriuretic peptides thresholds.
Time frame: 1 year
Longer term 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%.
Time frame: 5 years
Longer term changes in left ventricular diastolic function
Proportion of participants with new diastolic dysfunction or worsening diastolic function ≥1 grade by echocardiography between the two study groups.
Time frame: 3 and 5 years
Clinical heart failure
Difference in proportion of participants with clinical HF between the two groups.
Time frame: 1 year
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. SF-36 3. EQ-5D-5L
Time frame: 3 and
Impact of gender
Differences in the GENESIS-PRAXY score between groups
Time frame: 1 year
Novel biomarkers and genomic factors
Incidence of novel biomarkers and genomic factors that may determine the risk of developing the primary endpoint between the two groups.
Time frame: 1 year
Non-Compliance at 3 and 5 years
Proportion of patients with non-compliance at 3 and 5 years .
Time frame: 3 years, 5 years
Primary outcome by CMR or echocardiography in each group by 3 or 5 years, stratified by baseline LVEF.
The proportion of those that develop the primary outcome by CMR or echocardiography in each group by 3 or 5 years follow-up stratified by baseline LVEF 50-55% versus \>55%.
Time frame: 3 years, 5 years
Plan to share: No
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Started Mar 2024 (actual). Primary completion is estimated for Dec 2027, 45 months after the start.
Of 164 non-industry phase 4 interventional studies under Heart Failure, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 56. This study's planned 45 months is above that.
Counting every sponsor, half of 183 studies reached it within 31 months; a quarter within 22 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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