The STOP-MED CTRCD Trial
Research type
Research Study
Full 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
IRAS ID
340455
Contact name
Charlotte Manisty
Contact email
Sponsor organisation
Toronto General Hospital University Health Network
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 4 months, 31 days
Research summary
Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump is reduced, as a side effect of cancer therapy. This can occur as commonly as 1 in 5 patients. When this occurs, heart failure medications are started to protect the heart from weakening further. 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. 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 little scientific evidence in this area.
To address this knowledge gap, the STOP-MED randomized control trial will assess the safety of stopping heart failure medication in patients with CTRCD and recovered heart function. The study will enrol patients who have completed their cancer therapy and are on heart medications for their CTRCD, which has now normalized. The study will randomize patients with no other reasons to continue heart failure medications to continuing or stopping their heart medications safely. All patients will undergo a MRI of the heart at baseline, 1 and 5 years with safety assessments at 6-8 weeks, 6 and 9 months and 3 and 5 years. The study will determine if stopping medications is not inferior to continuing medications by counting the numbers of patients who develop heart dysfunction by 1 year in each group.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0288
Date of REC Opinion
1 Nov 2024
REC opinion
Further Information Favourable Opinion