[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532852":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":61,"centralContacts":65,"locations":71,"responsibleParty":88,"collaborators":90,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":27,"enrollmentInfo":104,"targetDuration":27,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":27,"overallStatus":73,"whyStopped":27,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Heart Center Research, LLC","NETWORK",[8,16,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Diuretic protocol","ACTIVE_COMPARATOR","If asymptomatic at time of HeartLogic(HL) alert, will add or increase diuretic based on current medications.\n\nIf currently taking ≤ 20 mg. furosemide, begin furosemide 40mg orally daily until recovery from alert or re-alert. If currently taking ≥ 40mg furosemide begin torsemide 20 mg orally daily or bumetanide 1 mg orally daily. If patient unable to obtain torsemide or bumetanide double furosemide daily dose (maximum 480mg daily).\n\nIf currently taking ≥ 20mg torsemide or ≥ 1mg bumetanide, double daily dose. Recheck HeartLogic index 7 days following initiation of diuretic protocol. If patient recovers from alert consider reducing dose or stopping diuretic. If HeartLogic index is lower but still in alert continue current diuretic dose. If HeartLogic index is the same or higher double diuretic dose and\u002For add metolazone 2.5mg for 1-2 days.",[13,14,15],"Drug: Furosemide","Drug: Torsemide","Drug: Bumetanide",{"label":17,"type":10,"description":18,"interventionNames":19},"Afterload reduction protocol","If asymptomatic at time of HL alert, increase afterload reduction drugs based on current medications.\n\nIf on Sacubitril\u002Fvalsartan, double the dose. If on maximum Sacubitril\u002Fvalsartan, add Hydralazine 10mg and Isordil10 mg both three times a day. If on Angiotensin Receptor Blocker (ARB) at low dose (less than or equal to Valsartan 160mg daily or equivalent) then stop ARB and start sacubitril\u002Fvalsartan 24-26mg twice a day. If on ARB at high dose (greater than Valsartan 160mg daily or equivalent) then immediately stop ARB and start Sacubitril\u002Fvalsartan 49-51mg twice a day. If on Angiotensin-converting enzyme (ACE) inhibitor at low dose (less than or equal to 10mg daily or equivalent) then immediately stop ACE inhibitor and start Sacubitril\u002Fvalsartan 24-26mg twice a day after 48hours. If on ACE inhibitor at high dose (greater than Enalapril 10mg daily or equivalent) stop ACE inhibitor and start Sacubitril\u002Fvalsartan 49-51mg twice a day after 48hours. Cut diuretic in half for all.",[20,21,22],"Drug: sacubitril\u002Fvalsartan","Drug: Hydralazine","Drug: Isosorbide Dinitrate",{"label":24,"type":25,"description":26,"interventionNames":27},"Observation protocol","NO_INTERVENTION","Standard therapy offered until development of symptoms of heart failure decompensation occurs. Patients will be monitored until out of alert and at 30, 60, and 90 days.",null,[29,36,41,46,51,56],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Furosemide","oral administration",[9],[35],"Lasix",{"type":30,"name":37,"description":32,"armGroupLabels":38,"otherNames":39},"Torsemide",[9],[40],"Demadex",{"type":30,"name":42,"description":32,"armGroupLabels":43,"otherNames":44},"Bumetanide",[9],[45],"Bumex",{"type":30,"name":47,"description":32,"armGroupLabels":48,"otherNames":49},"sacubitril\u002Fvalsartan",[17],[50],"Entresto",{"type":30,"name":52,"description":32,"armGroupLabels":53,"otherNames":54},"Hydralazine",[17],[55],"Apresoline",{"type":30,"name":57,"description":32,"armGroupLabels":58,"otherNames":59},"Isosorbide Dinitrate",[17],[60],"Dilatrate, Isordil",[62],{"name":63,"affiliation":5,"role":64},"Jay Dinerman, MD","PRINCIPAL_INVESTIGATOR",[66],{"name":67,"role":68,"phone":69,"phoneExt":27,"email":70},"COO","CONTACT","256-519-8472","leskridge@theheartcenter.md",[72],{"facility":5,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"RECRUITING","Huntsville","Alabama","35801","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-86.58594,34.7304,{"lat":83,"lon":82},[86,87],{"name":67,"role":68,"phone":69,"phoneExt":27,"email":70},{"name":63,"role":64,"phone":27,"phoneExt":27,"email":27},{"type":89,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[91],{"name":92,"class":93},"Boston Scientific Corporation","INDUSTRY","100532852","phase-4-diuretics-vs-afterload-reduction-for-treatment-of-heartlogic-alerts-100532852",false,"NCT06218199","Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts","Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts (DART-HA)","DART-HA","Inclusion Criteria:\n\n* Boston Scientific device with HeartLogic enabled\n* Lack of standard contraindications to Sacubitril\u002Fvalsartan:\n\n  * history of ACE-inhibitor induced angioedema and in those with angiotensin II receptor blocker (ARB) therapy induced angioedema.\n  * hypotension, hypovolemia\n  * renal artery stenosis, renal failure\n  * hyperkalemia\n  * hepatic disease Child-Pugh class C\n  * Pregnancy\u002FBreast-feeding\n* Lack of standard contraindications to diuretic therapy\n* Systolic Blood Pressure \\> 105\n\nExclusion Criteria:\n\n* Glomerular filtration rate \\\u003C25 mL\u002Fmin who are non-responsive to diuretic therapy or are on chronic renal dialysis\n* ongoing symptoms of heart failure decompensation (increased dyspnea and\u002For fatigue, for purposes of this study increased weight is not considered, see question 2 KCCQ).\n* recent significant change in arrhythmia burden (within the past 2 weeks)\n* in cardiac resynchronization therapy (CRT) patients, recent change (60 days) in effective delivery of CRT (eg. decreased biventricular paving %)\n* the subject is unable to sign or refuses to sign the patient informed consent\n* Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment\n* the subject is implanted with unipolar right atrial or right ventricular leads\n* subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months\n* subject is pregnant or planning to become pregnant during the study\n* regularly scheduled IV heart failure therapy (e.g. inotropes or diuretics)","ALL","19 Years",{"count":105,"type":106},80,"ESTIMATED","INTERVENTIONAL",[109],"PHASE4","The DART-HA study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure diagnostic feature.",[112],"Heart Failure, Congestive","2024-01-25",{"date":115,"type":116},"2024-01-29","ACTUAL",{"date":118,"type":116},"2021-07-08",{"date":120,"type":106},"2026-12-31",{"name":5,"class":6},1]