[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"antineoplastics-toxicity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:antineoplastics-toxicity":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100530181","phase-4-the-stop-med-ctrcd-trial-100530181",false,"NCT06183437","The STOP-MED CTRCD Trial","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","STOP-MED CTRCD","Inclusion Criteria:\n\n* 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.\n* Prior cancer therapy with anthracyclines and\u002F or HER2-targeted therapy.\n* Prior asymptomatic, moderate to severe CTRCD, defined using the ESC\u002FICOS criteria (MODERATE: ≥10% drop in LVEF from baseline to 40% to 49.9% OR \\\u003C10% drop to 40-49.9% with a reduction in GLS by \\>15% or new abnormal Troponin I\u002FT or NT-proBNP or SEVERE: new LVEF reduction to \\\u003C40% from normal baseline LVEF), diagnosed within 1 year of completing potentially cardiotoxic cancer therapy.\n* Current use of ≥1 HF medication started for CTRCD for at least 6 months with LVEF ≥50% by recently performed (≤6 months) echocardiogram, normal sex and age adjusted NT-proBNP or BNP ≤97.5th Centile, and no symptoms attributable to HF.\n* Reference ranges for NT-proBNP and BNP by age and sex:\n\n\\\u003C30 years: Female: NT-proBNP ≤196 pg\u002Fml, BNP ≤55 pg\u002Fml Male: NT-proBNP ≤104 pg\u002Fml, BNP ≤29 pg\u002Fml\n\n30-39 years: Female: NT-proBNP ≤209 pg\u002Fml, BNP ≤59 pg\u002Fml Male: NT-proBNP ≤102 pg\u002Fml, BNP ≤29 pg\u002Fml\n\n40-49 years: Female: NT-proBNP ≤233 pg\u002Fml, BNP ≤65 pg\u002Fml Male: NT-proBNP ≤137 pg\u002Fml, BNP ≤38 pg\u002Fml\n\n50-59 years: Female: NT-proBNP ≤299 pg\u002Fml, BNP ≤84 pg\u002Fml Male: NT-proBNP ≤195 pg\u002Fml, BNP ≤55 pg\u002Fml\n\n60-69 years: Female: NT-proBNP ≤399 pg\u002Fml, BNP ≤112 pg\u002Fml Male: NT-proBNP ≤333 pg\u002Fml, BNP ≤93 pg\u002Fml\n\n70-79 years: Female: NT-proBNP ≤743 pg\u002Fml, BNP ≤208 pg\u002Fml Male: NT-proBNP ≤763 pg\u002Fml, BNP ≤214 pg\u002Fml\n\n≥80 years: Female: NT-proBNP ≤2,704 pg\u002Fml, BNP ≤757 pg\u002Fml Male: NT-proBNP ≤6,792 pg\u002Fml, BNP ≤1,902 pg\u002Fml\n\n* Confirmation of LVEF ≥50% and normal volumes at baseline CMR (i.e., some patients recruited based on echocardiography, may be excluded if baseline CMR LVEF\u002Fvolumes are not normal). This is included given that the primary outcome includes the use of CMR LVEF.\n* Normal Ventricular end-diastolic volumes by CMR as defined by the Society of Cardiac Magnetic Resonance 2025 update.\n\nExclusion Criteria:\n\n* 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 pre-CTRCD will continue their antihypertensive as only medication started for CTRCD will be ceased).\n* Contraindications for CMR (e.g., MRI non-compatible implanted pacemakers).\n* Patients with cardiac devices i.e. defibrillator, CRT, pacemaker, etc.\n* Continued use of loop diuretic therapy for heart failure purposes i.e., furosemide.\n* Life expectancy \\\u003C1 year or metastatic disease.\n* 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)).\n* Issues that prevent communication, understanding or presentation for study-related visits and inability to provide informed consent.","ALL","18 Years",{"count":20,"type":21},335,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","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.\n\nTo 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.",[27,28,29,30,31],"Heart Failure","Cardiotoxicity","Cardiac Toxicity","Antineoplastics Toxicity","Cancer",[33],"cancer therapy related cardiac dysfunction","RECRUITING","2026-07-03",{"date":37,"type":38},"2026-07-07","ACTUAL",{"date":40,"type":38},"2024-03-04",{"date":42,"type":21},"2031-12",{"name":44,"class":45},"Dinesh Thavendiranathan","OTHER",14,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100431802","immune-checkpoint-inhibitors-nephrotoxicity-100431802","NCT04902846","Immune Checkpoint Inhibitors Nephrotoxicity","Application of Biomarkers of Renal Damage in Patients Treated With Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Patients waiting for immunotherapy or combination immunotherapy \u002F platinum compounds\n\nExclusion Criteria:\n\n* Patients who are terminally ill\n* Patients who do not wish to sign the informed consent","100 Years",{"count":56,"type":21},220,"OBSERVATIONAL","In recent years, immunotherapy has been postulated as one of the most effective strategy in the fight against cancer. The greatest success in this field has been achieved through the inhibition of molecules involved in the brake of the adaptive immune response. The compounds capable of blocking the action of these molecules constitute the \"immune checkpoint inhibitors\" (ICI). Despite its efficacy, the treatment with ICI causes adverse effects, and in the case of kidney damage, the prognosis has been shown to worsen in cancer patients who develop renal dysfunction. Currently, the diagnosis based on laboratory tests is insufficient to predict the underlying kidney injury and identify the type of damage. The hypothesis proposed that the renal lesion could be subclinical, and therefore the possibility of using new urinary biomarkers could be a useful diagnostic tool that would allow these patients to be managed in a preventive (risk markers) and early way (early markers), and even to elucidate if renal damage is due to this therapy or to other factors (differential diagnostic markers). To develop this hypothesis it is proposed to validate biomarkers in patients treated with ICI by developing a prospective study. The diagnostic products derived from this study will improve the clinical practice of cancer treatment with ICI, and therefore the expectancy and quality of life of patients.",[60,30],"Kidney Injury",[62,63,64,65,66],"Diagnosis","Nephrotoxicity","Prevention","Oncology","Immune check point inhibitors","2025-02-25",{"date":69,"type":38},"2025-02-26",{"date":71,"type":38},"2021-05-19",{"date":73,"type":21},"2030-12-30",{"name":75,"class":45},"R. Laura Vicente Vicente"]