[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100570806","phase-3-effect-of-angiotensin-receptorneprilysin-inhibitors-on-transthyretin-cardiac-amyloidosis-and-heart-failure-with-reduced-ejection-fraction-100570806",false,"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.","ALL","18 Years",{"count":20,"type":21},114,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)",[29,30,31,32],"Heart failure","Reduced ejection fraction","Angiotensin receptor\u002Fneprilysin inhibitors","Sacubitril valsartan","NOT_YET_RECRUITING","2024-11-26",{"date":36,"type":37},"2024-12-02","ACTUAL",{"date":39,"type":21},"2025-01",{"date":41,"type":21},"2027-06",{"name":43,"class":44},"Puerta de Hierro University Hospital","OTHER"]