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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06183437
Other study ID # STOPMED-1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 4, 2024
Est. completion date December 2031

Study information

Verified date March 2024
Source University Health Network, Toronto
Contact Paaladinesh Thavendiranathan, MD
Phone 416-340-5326
Email dinesh.thavendiranathan@uhn.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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 and 9 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 335
Est. completion date December 2031
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 CTRCD, defined using the European Society of Cardiology criteria (=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), 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 NT-proBNP, and no symptoms attributable to HF. - 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. 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 severe CTRCD defined as having a nadir LVEF <40% due to the known poor prognosis in these patients. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Stopping Heart Failure Medication(s)
This group will stop their heart failure medication(s) under the supervision of the study team.

Locations

Country Name City State
Australia Baker Heart and Diabetes Institute Melbourne Victoria
Canada Foothills Medical Centre Calgary Alberta
Canada Edmonton Clinic Health Academy Edmonton Alberta
Canada Hamilton General Hospital Hamilton Ontario
Canada University of Ottawa Heart Institute Ottawa Ontario
Canada St Michael's Hospital Toronto Ontario
Canada University Health Network Toronto Ontario
Canada St. Boniface Hospital Winnipeg Manitoba
United Kingdom University College London London
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (10)

Lead Sponsor Collaborator
University Health Network, Toronto Alberta Health Services, Calgary, Baker Heart and Diabetes Institute, Brigham and Women's Hospital, Hamilton Health Sciences Corporation, St. Boniface Hospital, Unity Health Toronto, University College London Hospitals, University of Alberta, University of Ottawa Heart Institute, Canada

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Longer term changes in cardiac magnetic resonance parameters Differences between the two groups in the following measures.
Changes in CMR LVEF as a continuous parameter.
Proportion of participants with increased CMR indexed LV volumes by =10% to higher-than-normal limits.
Proportion of participants with decline in CMR LVEF to <50% with a >10% absolute fall compared to pre-HF medication withdrawal.
CMR peak systolic global longitudinal strain (GLS) worsening by >15%.
5 years
Other 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. 3 and 5 years
Other Clinical heart failure Difference in proportion of participants with clinical HF between the two groups. 1 year
Other Changes in quality of life score Difference in patient questionnaires scores between the two groups using the following patient questionnaires:
Kansas City Cardiomyopathy Questionnaire
SF-36
EQ-5D-5L
3 and
Other Impact of gender Differences in the GENESIS-PRAXY score between groups 1 year
Other 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. 1 year
Primary 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% 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. 1 year
Secondary Changes in cardiac magnetic resonance parameters Differences between the two groups in the following measures.
Changes in CMR LVEF as a continuous parameter.
Proportion of participants with increased CMR indexed LV volumes by =10% to higher-than-normal limits.
Proportion of participants with decline in CMR LVEF to <50% with a >10% absolute fall compared to pre-HF medication withdrawal.
CMR peak systolic global longitudinal strain (GLS) worsening by >15%.
1 year
Secondary Left ventricular diastolic function Proportion of participants with new diastolic dysfunction or worsening diastolic function =1 grade by echocardiography between the two study groups. 1 year
Secondary 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. 1 year
Secondary 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. 1 year
Secondary Changes in quality of life score Difference in patient questionnaires scores between the two groups using the following patient questionnaires:
Kansas City Cardiomyopathy Questionnaire
Short Form (SF) Survey -36
EQ-5D-5L
1 year
Secondary Cost effectiveness analysis We will compare the cost per quality adjusted life years between the two study groups. 1 year
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