[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570806":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":48,"studyPopulation":31,"armGroups":49,"interventions":60,"overallOfficials":66,"centralContacts":71,"locations":76,"responsibleParty":95,"collaborators":31,"id":98,"slug":31,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":31,"enrollmentInfo":107,"targetDuration":31,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":121,"whyStopped":31,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Puerta de Hierro University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Change in left ventricular systolic function (%) assessed by echocardiogram.","Measured by biplane method in percentage","12 months",[14,17,20,23,26,29,32,35,37],{"measure":15,"description":16,"timeFrame":12},"Change in left ventricular systolic function assessed by global longitudinal strain (GLS)","Measure of longitudinal shortening as a percentage",{"measure":18,"description":19,"timeFrame":12},"Change in E\u002Fe' ratio measured by echocardiogram.","Ratio between E wave (peak velocity of early diastolic blood flow across the mitral valve, measured using transmitral Doppler) and E' (E prime): velocity of early diastolic mitral annular motion, measured using tissue Doppler imaging.",{"measure":21,"description":22,"timeFrame":12},"Change in functional capacity assessed by 6-minute walk test","Distance covered over a time of 6 minutes in a flat surface in meters.",{"measure":24,"description":25,"timeFrame":12},"Change in quality of life according to the Kansas City Cardiomyopathy Questionnaire","0 to 100 scale, where 0 is the worst possible health status and 100 best possible health status.",{"measure":27,"description":28,"timeFrame":12},"Change in N-terminal pro-B-type natriuretic peptide (NTproBNP) biomarker level.","Measure in blood. Unit pg\u002Fml.",{"measure":30,"description":31,"timeFrame":12},"Proportion of patients experiencing cardiovascular hospitalizations.",null,{"measure":33,"description":34,"timeFrame":12},"Proportion of patients experiencing adverse events","Including serious adverse event, grade 3-4 adverse event, adverse reaction, adverse event of special interest.",{"measure":36,"description":31,"timeFrame":12},"Proportion of patients discontinuing treatment",{"measure":38,"description":31,"timeFrame":12},"Proportion of patients experiencing all-cause mortality.",{"allocation":40,"interventionModel":41,"interventionModelDescription":31,"primaryPurpose":42,"observationalModel":31,"timePerspective":31,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":45,"whoMasked":46},"SINGLE","The analysis of the echocardiogram will be performed by evaluators blinded to the treatment and the timing of the imaging.",[47],"OUTCOMES_ASSESSOR","Transthyretin cardiac amyloidosis (ATTR) has emerged as a prevalent and underdiagnosed cause of heart failure (HF), affecting patients both with preserved left ventricular ejection fraction (LVEF) and with systolic dysfunction. It remains unclear whether this population benefits from standard treatments for HF with reduced LVEF or whether treatment with renin-angiotensin system inhibitors and neprilysin might even be harmful in ATTR.\n\nThe investigators plan to conduct a prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of Sacubitril\u002FValsartan (Sac\u002FVals), as recommended in current HF guidelines, versus no treatment in patients with ATTR and heart failure with reduced ejection fraction (HFrEF), including those with LVEF ≤40%.\n\nApproximately 114 patients from four Spanish centers will be randomized 1:1 to receive Sac\u002FVals treatment (up to the maximum tolerated dose) or to not initiate the drug, with stratification by center and tafamidis treatment. It has been included a run-in period with a low dose of Sac\u002FVals to assess tolerance prior to randomization. Patients will have scheduled follow-up visits at 3, 6, and 12 months, during which clinical, functional, analytical, electrocardiographic, and echocardiographic variables will be evaluated.\n\nThe primary objective is to determine the impact of Sac\u002FVals treatment on systolic function in patients with ATTR and HFrEF by assessing the change in LVEF on echocardiogram at 12 months. Improvement in LVEF will be defined as an increase of ≥5% from the baseline echocardiogram to the 12-month follow-up.",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Sacubitril\u002FValsartan","EXPERIMENTAL","Sacubitril\u002Fvalsartan up to maximum tolerated dose",[55],"Drug: Sacubitril \u002F Valsartan",{"label":57,"type":58,"description":59,"interventionNames":31},"No treatment","NO_INTERVENTION","No initiation of Sacubitril\u002Fvalsartan",[61],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":31},"DRUG","Sacubitril \u002F Valsartan","Dose titration of Sacubitril\u002FValsartán to the maximum tolerated dose (maximum 97\u002F103 mg)",[51],[67],{"name":68,"affiliation":69,"role":70},"Esther Gonzalez Lopez, MD, PhD","Heart Failure and Inherited Cardiac Diseases Unit, Department of Cardiology, Hospital Universitario Puerta de Hierro, IDIPHISA, Madrid, Spain","PRINCIPAL_INVESTIGATOR",[72],{"name":68,"role":73,"phone":74,"phoneExt":31,"email":75},"CONTACT","+34 91 1916000","egonzalezlopez@salud.madrid.org",[77],{"facility":78,"status":31,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Hospital Universitario Puerta de Hierro","Majadahonda","Madrid","28222","Spain","ES",{"type":85,"coordinates":86},"Point",[87,88],-3.87182,40.47353,{"lat":88,"lon":87},[91,92],{"name":68,"role":73,"phone":74,"phoneExt":31,"email":75},{"name":93,"role":73,"phone":31,"phoneExt":31,"email":94},"Noemí Ramos López","nramosl@cnic.es",{"type":70,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Esther Gonzalez López","Principal Investigator","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":108,"type":109},114,"ESTIMATED","INTERVENTIONAL",[112],"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.",[115],"Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)",[117,118,119,120],"Heart failure","Reduced ejection fraction","Angiotensin receptor\u002Fneprilysin inhibitors","Sacubitril valsartan","NOT_YET_RECRUITING","2024-11-26",{"date":124,"type":125},"2024-12-02","ACTUAL",{"date":127,"type":109},"2025-01",{"date":129,"type":109},"2027-06",{"name":5,"class":6},1]