The STOP-MED CTRCD Trial
a study on Heart Failure Cardiotoxicity Cardiac Toxicity Antineoplastics Toxicity Cancer, General Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Los Angeles, California and other locations
- Dates
- study startedstudy ends around
- Principal Investigator
- by Eric Yang, MD
Description
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.
Official Title
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
Keywords
Heart Failure, Cardiotoxicity, Cardiac Toxicity, Antineoplastics Toxicity, Cancer, cancer therapy related cardiac dysfunction, Neoplasms, Stopping Heart Failure Medication(s)
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 ≥55% 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 ≥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.
You CAN'T join if...
- 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 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.
Locations
- University of California, Los Angeles
not yet accepting patients
Los Angeles California 90095 United States - Cardio-Oncology Clinic, MAHI, University of Alberta Hospital
not yet accepting patients
Edmonton Alberta T6G 1C9 Canada - St. Boniface Hospital
accepting new patients
Winnipeg Manitoba R2H 2A6 Canada - University Health Network
accepting new patients
Toronto Ontario M5G2C4 Canada - St Michael's Hospital
not yet accepting patients
Toronto Ontario M5B 1W8 Canada
Lead Scientist at UCLA
- Eric Yang, MD
Professor Of Clinical, Medicine. Authored (or co-authored) 206 research publications. Research interests: Cardio-Oncology · Medical Education · Valvular Disease · Interventional Echocardiography · Cardiac Computed Tomography
Details
- Status
- accepting new patients at some sites,
but this study is not currently recruiting here - Start Date
- Completion Date
- (estimated)
- Sponsor
- Dinesh Thavendiranathan
- ID
- NCT06183437
- Phase
- Phase 4 research study
- Study Type
- Interventional
- Participants
- Expecting 335 study participants
- Last Updated