[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569394":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":31,"studyPopulation":31,"armGroups":41,"interventions":52,"overallOfficials":61,"centralContacts":65,"locations":71,"responsibleParty":90,"collaborators":93,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":31,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":31,"enrollmentInfo":106,"targetDuration":31,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":31,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Mayo Clinic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":31,"otherOutcomes":31},[9,13,16,19,22,25,28],{"measure":10,"description":11,"timeFrame":12},"Ventricular function","Ventricular Function will be determined by indices of Right Ventricle (RV) and Left Ventricle (LV) systolic and diastolic function indices acquired from CMRI and transthoracic echocardiographic imaging.","Baseline, Week 52",{"measure":14,"description":15,"timeFrame":12},"Ventricular structure","Ventricular structure will be determined by Right Ventricle (RV) and Left Ventricle (LV) size and wall thickness acquired from CMRI and transthoracic echocardiographic imaging.",{"measure":17,"description":18,"timeFrame":12},"Change from baseline in Hs-Troponin","Hs-Troponin will be determined by blood specimen and will be measured in ng\u002FL. A higher value indicates damage to the heart.",{"measure":20,"description":21,"timeFrame":12},"Change from baseline in Galectin 3","Galectin 3 will be determined by blood specimen and will be measure in ng\u002FmL. A higher value indicates a higher severity of heart disease.",{"measure":23,"description":24,"timeFrame":12},"Change from baseline in Cystatin C","Cystatin C will be determined by blood specimen and measured in mg\u002FL. A lower value reflects better kidney function.",{"measure":26,"description":27,"timeFrame":12},"Change in baseline in Soluble ST-2 (sST-2)","Soluble ST-2 (sST-2) will be determined by blood specimen and measured in ng\u002FmL. A higher value indicates a higher severity of heart failure.",{"measure":29,"description":30,"timeFrame":12},"Patient reported outcomes","Patient reported outcomes will be determined by a quality-of-life questionnaire. A self-assessment survey to assess the extent to which heart failure (HF) affects the patient's activities of daily living and quality of life. The questionnaire is 12 questions and a lower score reflects more severe the limitations on daily life.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":38},"DOUBLE",[39,40],"PARTICIPANT","INVESTIGATOR",[42,47],{"label":43,"type":44,"description":31,"interventionNames":45},"Entresto","EXPERIMENTAL",[46],"Drug: Entresto Pill",{"label":48,"type":49,"description":31,"interventionNames":50},"Placebo","PLACEBO_COMPARATOR",[51],"Other: Placebo",[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":31},"DRUG","Entresto Pill","Patients will take a 24\u002F26 mg dose orally, twice daily, for weeks 1 and 2, 49\u002F51 mg orally, twice daily, for weeks 3 and 4, and 97\u002F103 mg orally twice daily, for the remaining 48 weeks (total duration: 52 weeks).",[43],{"type":6,"name":48,"description":59,"armGroupLabels":60,"otherNames":31},"Patients taking placebo tablets will take 1 tablet orally, twice daily",[48],[62],{"name":63,"affiliation":5,"role":64},"Alexander Egbe","PRINCIPAL_INVESTIGATOR",[66],{"name":67,"role":68,"phone":69,"phoneExt":31,"email":70},"Amanda Wozniak","CONTACT","507-266-1976","Wozniak.Amanda@mayo.edu",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Mayo Clinic in Rochester","RECRUITING","Rochester","Minnesota","55905","United States","US",{"type":81,"coordinates":82},"Point",[83,84],-92.4699,44.02163,{"lat":84,"lon":83},[87,88],{"name":67,"role":68,"phone":69,"phoneExt":31,"email":70},{"name":89,"role":64,"phone":31,"phoneExt":31,"email":31},"Alexander C Egbe",{"type":64,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Alexander C. Egbe","Principal Investigator",[94],{"name":95,"class":96},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100569394","phase-3-effect-of-sacubitril-valsartan-on-cardiac-structure-and-function-100569394",false,"NCT06693674","Effect of Sacubitril-Valsartan on Cardiac Structure and Function","Effect of Sacubitril-Valsartan on Cardiac Structure and Function in Adults With Congenital Heart Disease","Inclusion Criteria:\n\n* Congenital Heart Disease Diagnosis\n* Age 18 or Older\n\nExclusion Criteria:\n\n* Stage IV chronic kidney disease defined as creatinine clearance \\\u003C30 ml\u002Fmin\n* Hyperkalemia defined as serum potassium \\>5.2 mmol\u002Fl,\n* Hypotension defined as systolic blood pressure \\\u003C100 mmHg,\n* History of angioedema related to previous ACE or ARB therapy\n* Patients diagnosed with diabetes using Aliskiren,\n* Pregnancy.\n* Drug Therapies\n\n  * Amifostine\n  * Droperidol\n  * Dantrolene\n  * CYP3A4 Inhibitors\n  * Obinutuzumab\n  * Aliskiren\n  * Lithium\n  * Sparsentan\n  * ACE inhibitor\n  * ARB\n  * ARNI","ALL","18 Years",{"count":107,"type":108},45,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","The purpose of this study is to compare changes in cardiac structure and function, biomarkers, and patient reported outcomes between adults with congenital heart disease (ACHD) randomized to angiotensin receptor-neprilysin inhibitor (ARNI) therapy vs placebo.",[114],"Congenital Heart Disease","2026-10-06",{"date":117,"type":118},"2026-10-09","ACTUAL",{"date":120,"type":118},"2025-02-03",{"date":122,"type":108},"2028-08",{"name":5,"class":6},1]