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
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 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.
Arms & interventions
- OtherStopping Heart Failure Medication(s)
This group will stop their heart failure medication(s) under the supervision of the study team.
Outcome measures
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% 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
Secondary
Changes in cardiac magnetic resonance parameters
Time frame: 1 year
Left ventricular diastolic function
Time frame: 1 year
Non-adherence of heart failure medication(s)
Time frame: 1 year
N-terminal pro B-type Natriuretic Peptide (NT-pro BNP)
Time frame: 1 year
Changes in quality of life score
Time frame: 1 year
Cost effectiveness analysis
Time frame: 1 year
Proportion of participants developing the primary outcome by whether they developed moderate versus severe CTRCD at original diagnosis
Time frame: 1 year
Incidence of 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.
Time frame: 1 year
Eligibility criteria
Study locations (2)
University of California, Los Angeles
Los Angeles, California, 90095
Brigham and Women's Hospital
Boston, Massachusetts, 02115