[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transthyretin-amyloidosis-cardiomyopathy-attr-cm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transthyretin-amyloidosis-cardiomyopathy-attr-cm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100646198","phase-4-cardiac-magnetic-resonance-and-echocardiography-study-with-acoramidis-100646198",false,"NCT07695701","Cardiac Magnetic Resonance and Echocardiography Study With Acoramidis","An Open-Label Study to Investigate the Long-Term Effects of Acoramidis on Cardiac Function, Structure and Cardiac Amyloid Burden in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)","ASCEND-ATTR","Key Inclusion Criteria:\n\n* Participants aged 18 to 80\n* Confirmed diagnosis of ATTR-CM requiring targeted therapy\n* At screening: New York Heart Association (NYHA) Class I\u002FII; estimated glomerular filtration rate (eGFR) ≥40 mL\u002Fmin\u002F1.73m2; left ventricular ejection fraction (LVEF) \\>35%; left ventricular (LV) wall thickness ≥12 mm.\n* Heart failure condition has been clinically stable for at least 6 weeks prior to screening.\n\nKey Exclusion Criteria:\n\n* Current or planned implantation of a cardiac implantable electronic device (eg, pacemaker, implantable cardiac defibrillator).\n* Acute myocardial infarction, acute coronary syndrome or coronary revascularization, or experienced stroke or transient ischemic attack within 90 days prior to screening.\n* Hemodynamic instability.\n* Likely to undergo heart transplantation within 12 months from screening.\n* Confirmed diagnosis of AL amyloidosis at screening.\n* At screening: NYHA Class III\u002FIV; National Amyloidosis Center (NAC) Stage 3.\n* Prior or current treatment with acoramidis.","ALL","18 Years","80 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The study aims to evaluate the effect of acoramidis on cardiac functional and structural improvement in participants with ATTR-CM.",[28,29,30,31],"Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)","Amyloidosis","Amyloid Cardiomyopathy","Transthyretin Amyloidosis",[33,34,35,36,37],"amyloidosis","cardiomyopathy","ATTR-CM","Amyloid","TTR","RECRUITING","2026-07-27",{"date":41,"type":42},"2026-07-29","ACTUAL",{"date":44,"type":22},"2026-07",{"date":46,"type":22},"2030-11",{"name":48,"class":49},"Eidos Therapeutics, a BridgeBio company","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":50},"100570806","phase-3-effect-of-angiotensin-receptorneprilysin-inhibitors-on-transthyretin-cardiac-amyloidosis-and-heart-failure-with-reduced-ejection-fraction-100570806","NCT06712030","Effect of Angiotensin Receptor\u002FNeprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction","Effect of Pharmacological Treatment with Angiotensin Receptor\u002FNeprilysin Inhibitors on Transthyretin Cardiac Amyloidosis and Heart Failure with Reduced Ejection Fraction (SAVA-TTR)","SAVA-TTR","Inclusion Criteria:\n\n* Patients ≥ 18 years of age of both sexes.\n* Patients diagnosed with ATTR cardiac amyloidosis as indicated in guidelines, both in its hereditary form (ATTRv) or wild-type form (ATTRwt).\n* Patients initially evaluated or under follow-up in Cardiomyopathy\u002FHeart Failure\u002FAmyloidosis Units at participating centers.\n* Heart failure and reduced ejection fraction: LVEF ≤40%, in functional class I, II, or III according to the New York Heart Association (NYHA).\n\nExclusion Criteria:\n\n* NYHA Functional Class IV.\n* Stage 4 and 5 chronic kidney disease (creatinine clearance by CKD-EPI \\\u003C30 mL\u002Fmin\u002F1.73m²).\n* Hyperkalemia (blood potassium levels \\> 5.4 mmol\u002FL).\n* Hypotension defined as systolic blood pressure (SBP) \\\u003C100 mmHg on two consecutive measurements.\n* Treatment with ACE inhibitors, ARBs, or sacubitril\u002Fvalsartan at the time of enrollment.\n* History of angioedema or hypersensitivity to ACE inhibitors or ARBs.\n* Treatment with TTR gene silencers or diflunisal.\n* Participation in another clinical trial.\n* Pregnancy, breastfeeding, or fertile women unwilling to use adequate contraception throughout the study duration.\n* Any condition that, in the investigator's opinion, compromises participation in the study.",{"count":60,"type":22},114,[62],"PHASE3","Prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of Sacubitril\u002FValsartan (Sac\u002FVals) compared to no initiation of the drug in patients with transthyretin cardiac amyloidosis (ATTR) and heart failure with reduced ejection fraction (LVEF ≤40%). The primary objective is to determine the impact of Sac\u002FVals treatment on systolic function by assessing the change in LVEF on echocardiogram at 12-month follow-up.",[28],[66,67,68,69],"Heart failure","Reduced ejection fraction","Angiotensin receptor\u002Fneprilysin inhibitors","Sacubitril valsartan","NOT_YET_RECRUITING","2024-11-26",{"date":73,"type":42},"2024-12-02",{"date":75,"type":22},"2025-01",{"date":77,"type":22},"2027-06",{"name":79,"class":80},"Puerta de Hierro University Hospital","OTHER"]