The STOP-MED CTRCD Trial

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Dec 13, 2023

Keywords

ClinConnect Summary

The STOP-MED CTRCD Trial is a clinical study that aims to find out whether patients who have recovered from heart problems caused by cancer treatments can safely stop taking their heart medication. Many cancer survivors experience heart issues after treatment, which can lead to heart failure. While these medications can help, they also come with long-term side effects and costs. The trial will enroll adult patients aged 18 and older who have completed their cancer treatment at least six months ago and are currently on heart medications because their heart function has improved. Participants must have had a specific type of heart problem related to their cancer treatment but are now showing normal heart function.

During the trial, those who qualify will be randomly assigned to either continue their heart medications or stop taking them. All participants will undergo heart scans at the beginning of the trial, and again at one year and five years, to monitor their heart health. The main goal is to see if stopping the medications is just as safe as continuing them, by checking how many patients develop heart problems after one year. This study is important as it could help improve the quality of life for cancer survivors by potentially reducing their medication burden.

Gender

ALL

Eligibility criteria

• 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 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.
• 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 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.