{"preliminary_commentary":{"by_channel":{"x_thread":5},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[],"indication":"recovered HER2-targeted therapy-related cardiac dysfunction","name":"HER-SAFE","nct_id":"NCT05880160","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=her-safe-nct05880160. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"HER-SAFE","arms":[{"description":"Participants will undergo phased withdrawal of heart failure/ cardioprotective treatments according to a pre-specified algorithm based on the 'Withdrawal of pharmacological treatment for heart failure in patients with recovered dilated cardiomyopathy' (TRED-HF) study protocol (Halliday et al 2019). Medications will be down titrated in a phased process every 2 weeks over 16 weeks maximum. Drug doses will be reduced by 50% every 2 weeks, until the patient is taking 25% or less of the maximum recommended dose at which point they will be stopped. Monitoring with fortnightly virtual consultations will confirm dose reduction and provide support. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using cardiovascular magnetic resonance scans and symptom and disutility questionnaires will be undertaken.","label":"Treatment Withdrawal","type":"EXPERIMENTAL"},{"description":"Participants will continue their current heart failure/ cardioprotective treatments. Participants will undergo clinical assessment at 6, 14 and 24 weeks and 6, 9 and 12 months with weight, blood pressure, and biomarker measurement. At baseline, 6- and 12-month visits detailed cardiovascular phenotyping using cardiovascular magnetic resonance scans and symptom and disutility questionnaires will be undertaken.","label":"Treatment Continuation","type":"NO_INTERVENTION"}],"collaborators":["British Heart Foundation","University College London Hospitals","Royal Brompton & Harefield NHS Foundation Trust","Imperial College Healthcare NHS Trust","The Whittington Hospital NHS Trust","Barts & The London NHS Trust"],"completion_date":{"date":"2026-06-24","type":"ACTUAL"},"conditions":["Cardiotoxicity","HER2-positive Breast Cancer","Heart Failure","Cancer, Therapy-Related"],"enrollment":{"count":90,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Phased withdrawal of heart failure medications","otherNames":[],"type":"OTHER"}],"last_update":"2026-09-28","lead_sponsor":"University College, London","official_title":"Randomised Control Trial for the Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction","overall_status":"COMPLETED","phases":["NA"],"primary_completion_date":{"date":"2026-06-24","type":"ACTUAL"},"primary_outcomes":[{"measure":"Relapse in Cardiotoxicity","timeFrame":"12 months"}],"references":[{"citation":"Dowsing B, Dehbi HM, Chung R, Pedra J, Worn O, Artico J, Schmid P, Roylance R, Kellman P, Moon JC, Crake T, Westwood M, Ghosh A, Andres MS, Nazir MS, Lyon AR, Chen D, Walker M, Manisty CH. HER-SAFE study design: an open-label, randomised controlled trial to investigate the safety of withdrawal of pharmacological treatment for recovered HER2-targeted therapy-related cardiac dysfunction. BMJ Open. 2025 Feb 5;15(2):e091917. doi: 10.1136/bmjopen-2024-091917.","pmid":"39909533","type":"DERIVED"}],"start_date":{"date":"2023-07-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety of Withdrawal of Pharmacological Treatment for Recovered HER2 Targeted Therapy Related Cardiac Dysfunction","url":"https://clinicaltrials.gov/study/NCT05880160"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/her-safe-nct05880160"}