[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lv-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lv-dysfunction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,69,100,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":41,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100569808","ai-enabled-direct-from-ecg-ejection-fraction-ef-severity-assessment-using-cor-ecg-wearable-monitor-100569808",false,"NCT06699056","AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor","AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Using COR ECG Wearable Monitor","EFACT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Able and eligible to wear a Holter monitor\n\nExclusion Criteria:\n\n* Receiving mechanical respiratory or circulatory support, or renal support therapy, at the time of screening or during Visit #1\n* Any condition that, in the investigator's opinion, could interfere with compliance with the study protocol or pose a safety risk to the participant\n* History of poor tolerance or severe skin reactions to ECG adhesive materials",true,"ALL","18 Years",{"count":21,"type":22},2000,"ESTIMATED","OBSERVATIONAL","This prospective, multicenter, cluster-randomized controlled study aims to evaluate the accuracy of an investigational artificial intelligence (AI) Software as a Medical Device (SaMD) designed to compute ejection fraction (EF) severity categories based on the American Society of Echocardiography's (ASE) 4-category scale. The software analyzes continuous ECG waveform data acquired by the FDA-cleared Peerbridge COR® ECG Wearable Monitor, an ambulatory patch device designed for use during daily activities. The AI software assists clinicians in cardiac evaluations by estimating EF severity, which reflects how well the heart pumps blood.\n\nIn this study, EF severity determination will be made using 5-minute ECG recordings collected during a 15-minute resting period with participants seated upright. The results will be compared to EF severity obtained from an FDA-cleared, non-contrast transthoracic echocardiogram (TTE) predicate device. This comparison aims to validate the accuracy of the AI software.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Ventricular Ejection Fraction","LVF","LV Dysfunction","Atrial Enlargement","Conduction Defect","Heart Failure","Valvular Heart Disease","Ischemic Heart Disease","Cardiotoxicity","Myocardial Infarction","Dilated Cardiomyopathy","HFrEF - Heart Failure With Reduced Ejection Fraction","HFpEF - Heart Failure With Preserved Ejection Fraction","Syncope","Remodeling, Cardiac",[42,43,44,45,46,47,48,28,49,50,51,52,53,54,29,55],"ECG Patch","LVEF","Holter","ECG Wearable","COR","Atrial Conduction","ECG Biomarker","SaMD","Clinical Decision Support","ECG","EF Severity","Ejection Fraction","AI","Electrical Remodeling","RECRUITING","2026-05-28",{"date":59,"type":60},"2026-06-01","ACTUAL",{"date":62,"type":60},"2024-11-21",{"date":64,"type":22},"2027-11-15",{"name":66,"class":67},"Peerbridge Health, Inc","INDUSTRY",8,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100547252","phase-2-midodrine-in-heart-failure-with-reduced-ejection-fraction-with-hypotension-100547252","NCT06405555","Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension","Midodrine in Heart Failure With Reduced Ejection Fraction With Hypotension: A Pilot, Open-label, Randomized Controlled Trial","MIDOH-HF-P","Inclusion Criteria:\n\n* Adults \\>= 18 years of age.\n* LVEF \\\u003C= 40 % within the last 3 months as determined by any one of: Transthoracic echocardiogram, transesophageal echocardiogram, cardiac magnetic resonance imaging, MUGA scan, angiogram with left ventriculogram.\n* AHA\u002FACC Stage B or C Heart Failure\n* Hospitalized patients in the ward setting OR in the cardiac intensive care unit (who are \\>= 48 hours after their last dose of vasopressor or inotrope).\n* Seated upright or supine SBP \\\u003C= 100 mmHg on two or more consecutive BP measurements separated by at least 8 hours\n\nExclusion Criteria:\n\n* Patient OR substitute decision-maker (SDM) unwilling or unable to provide informed consent\n* Documented allergy or intolerance to midodrine\n* Treatment for active infection (either documented infection or empiric treatment) with antimicrobials at the time of recruitment.\n* Current use OR any use within the last 48 hours of an intravenous inotrope or vasopressor medication OR the need for IV inotrope or vasoproessor use to treat hypotension\n* Patient within 72 hours of an acute coronary syndrome.\n* Heart transplant recipient.\n* Presence of temporary or durable mechanical circulatory support device.\n* Severe valvular disease expected to be intervened upon during the incident hospitalization.\n* Hyperkalemia \\>= 5.5 mmol\u002FL.\n* Baseline eGFR (as calculated by the CKD-EPI method) \\\u003C= 20 mL\u002Fmin\u002F1.73 m2 as measured within the last 3 months.\n* A treatable cause for hypotension, including but not limited to: hypovolemia (eg. Bleeding, overdiuresis, poor oral intake), obstructive shock, sepsis, adrenal insufficiency.\n* Clinical diagnosis of ongoing cardiogenic shock, or diagnosed as defined in SHOCK trial: sBP \\\u003C= 90 mmHg with evidence of end-organ hypoperfusion (cool extremities, urine output \\\u003C 30 mL\u002Fhr, HR \\> 60 bpm, or elevated lactate \\>=3.5 mmol\u002FL), invasive hemodynamic measurements (if available) of CI \\\u003C= 2.2 L\u002Fmin\u002Fm2 and a pulmonary capillary wedge pressure (PCWP) of \\>=15 mmHg.\n* Pregnant patient.\n* Anticipated patient discharge in less than two days from enrolment (ie. less than 6 anticipated doses of midodrine, if randomized to treatment\u002Fintervention arm).\n* Acute brain pathology (including, but not limited to intracranial hemorrhage or hematoma) in which most-responsible clinician deems it unsafe to augment blood pressure.\n* Untreated thyrotoxicosis\n* Acute or acute on chronic liver failure\n* Patient unable to take oral medications\n* Bradycardia with resting heart rate less than 50 beats per minute.\n* Patients on an equivalent dose of Lasix \\>= 80 mg IV BID",{"count":78,"type":22},56,"INTERVENTIONAL",[81,82],"PHASE2","PHASE3","The evidence-based pharmacologic treatments available for patients with heart failure with reduced ejection fraction (HFrEF) has been established over the last few decades of cardiovascular research. These treatments, termed Foundational Guideline-Directed-Medical Therapies (GDMT), prolong patient life, improve patient-reported symptoms, and reduce hospitalizations for heart failure. A direct effect of most medication classes encompassed within GDMT is the reduction in blood pressure due to their mechanisms of action. In addition, as patients with HFrEF become more advanced in their disease, a significant proportion develop hypotension related to pump failure and autonomic dysfunction, amongst other possible mechanisms. As a result, a significant proportion of HFrEF patients are not optimized on GDMT with hypotension as their limiting barrier that would otherwise have served to improve their heart function, heart failure symptoms, and mortality. Currently, there does not exist any evidence-based strategies to address the problem of hypotension in HFrEF patients who are not optimized on GDMT.\n\nMidodrine is an alpha-adrenergic agonist (α1-AR) that exerts its effects on peripheral venous and arteriolar vasculature to increase blood pressure. This medication has been used off-label by some clinicians in the hypotensive HFrEF population to increase blood pressure and has been reported to have beneficial effects in improving GDMT utilization as well as increasing left ventricular ejection fraction (LVEF) in published case reports\u002Fcase series. There does not exist any randomized prospective data on the use of midodrine in the hypotensive HFrEF population. The investigators' objective is to complete the first open-label, randomized control trial of midodrine in the hypotensive HFrEF population to demonstrate feasibility in performing a trial in this patient population and to show efficacy in increasing blood pressure without associated harm. The results of this trial will be used as the foundation and rationale for future studies assessing the impact of midodrine use on GDMT utilization as well as hard cardiovascular outcomes in the hypotensive HFrEF population, including hospitalizations for heart failure and mortality.",[85,86,28],"Heart Failure With Reduced Ejection Fraction","Hypotension",[31,88,89],"GDMT","Midodrine","NOT_YET_RECRUITING","2026-04-29",{"date":93,"type":60},"2026-04-30",{"date":59,"type":22},{"date":96,"type":22},"2028-06-01",{"name":98,"class":99},"Ottawa Heart Institute Research Corporation","OTHER",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":18,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":79,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"100570267","phase-2-study-to-assess-safety-and-efficacy-of-treating-symptomatic-ischemic-chronic-congestive-heart-failure-patients-with-an-lvef-of-40-with-fresh-uncultured-autologous-adipose-derived-regenerative-cells-isolated-from-lipoaspirate-100570267","NCT06705023","Study to Assess Safety and Efficacy of Treating Symptomatic, Ischemic, Chronic Congestive Heart Failure Patients with an LVEF of ≤40% with Fresh, Uncultured, Autologous, Adipose-derived Regenerative Cells Isolated from Lipoaspirate.","Adipose-derived Regenerative Cells Treatment for Congestive Heart Failure","Inclusion Criteria\n\n* Have documented coronary artery disease with evidence of myocardial injury, LV dysfunction, and clinical evidence of heart failure\n* Have an EF ≤40% by cardiac MRI\n* Be receiving guideline-driven medical therapy for heart failure at stable and tolerated doses for ≥1 month before consent\n* Be a candidate for right heart cardiac catheterization\n* Have New York Heart Association class I, II, or III heart failure symptoms\n* If a female of childbearing potential, be willing to use one form of birth control for the duration of the study, and undergo a pregnancy test at baseline and within 36 h before treatment\n\nExclusion Criteria\n\n* Indication for standard-of-care surgery (including valve surgery, placement of LV assist device, or imminent heart transplantation), CABG procedure, and PCI. Candidates cannot be UNOS 1A or 1B, and they must have documented low probability of being transplanted.\n* PCI within 3 months of randomization\n* CABG within 3 months of randomization\n* Valvular heart disease including mechanical or bioprosthetic heart valve, severe valvular (any valve) insufficiency\u002Fregurgitation within 12 month of consent, and aortic stenosis with valve area ≤1.5 cm2\n* History of ischemic or hemorrhagic stroke within 90 d of consent\n* History of an LV remodeling surgical procedure utilizing prosthetic material\n* Presence of a pacemaker and ICD generator with any of the following limitations\u002Fconditions: manufactured before the year 2015\n* Leads implanted \\\u003C6 week before consent\n* Non-transvenous epicardial or abandoned leads\n* Subcutaneous ICDs\n* Leadless pacemakers\n* Pacemaker-dependence with an ICD (pacemaker-dependent candidates without an ICD are not excluded)\n* Any other condition that, in the judgment of device-trained staff, would deem an MRI contraindicated\n* A CRT device implanted within 3 months of consent\n* An appropriate ICD firing or antitachycardia pacing for ventricular fibrillation or ventricular tachycardia within 30 days of consent\n* Ventricular tachycardia (≥20 consecutive beats) without an ICD within 3 month of consent, or symptomatic Mobitz II or higher degree atrioventricular block without a functioning pacemaker within 3 months of consent\n* Presence of LV thrombus\n* Baseline eGFR \\\u003C35 mL\u002Fmin per 1.73 m2\n* Poorly controlled blood glucose levels (HbA1c \\>10%)\n* Hematologic abnormality evidenced by hematocrit \\\u003C25%, white blood cell \\\u003C2500 per μL, or platelet count \\\u003C100 000 per μL\n* Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3× the ULN\n* Coagulopathy (INR ≥1.3) not due to a reversible cause (eg, warfarin and factor Xa inhibitors). Patients who cannot be withdrawn from anticoagulation will be excluded.\n* HIV or active HBV or HCV\n* Allergy to radiographic contrast material that cannot adequately be managed by premedication\n* Known history of anaphylactic reaction to penicillin or streptomycin\n* Received gene or cell-based therapy from any source within the previous 12 months\n* History of malignancy within 3 years, excluding basal cell carcinoma or cervical carcinoma in situ which have been definitively treated\n* Condition that limits expected lifespan to \\\u003C1 year\n* History of drug or alcohol abuse\n* Chronic immunosuppressant therapy such as corticosteroids or TNF-α antagonists\n* Cognitive or language barriers that prohibit obtaining informed consent or any study elements\n* Pregnancy or lactation or plans to become pregnant in the next 12 months\n* Conditions that, in the judgment of the Investigator or Sponsor, would impair enrollment, cell harvest, administration or follow-up\n\nALT indicates alanine aminotransferase; AST, aspartate aminotransferase; CABG, coronary artery bypass grafting; CRT, cardiac resynchronization therapy; EF, ejection fraction; eGFR, estimated glomerular filtration rate; HBV, hepatitis B virus; HCV, hepatitis C virus; HIV, human immunodeficiency virus; ICD, implantable cardioverter defibrillator; INR, international normalized ratio; LV, left ventricular; MRI, magnetic resonance imaging; PCI, percutaneous coronary intervention; TNF-α, tumor necrosis factor-α; ULN, upper limit of normal; UNOS, United Network for Organ Sharing; and Vo2 max, maximal oxygen consumption.","21 Years","80 Years",{"count":110,"type":22},36,[81],"To investigate patients suffering from iHF and a LVEF of equal or less than 40% despite best medical treatment safety and efficacy of a single retrograde intra-cardiac venous (i.cv.) injection of UA-ADRCs isolated from lipoaspirate at the point of care, using the Transpose® RT \u002F Matrase System (InGeneron, Houston, TX, USA) through an over-the- wire, small balloon catheter, advanced through the coronary si-nus and located within a coronary vein at the site of inter-est, versus patients on best medical treatment.",[114,28,115,31],"Myocardial Injury","Coronary Artery Disease",[117,118,119,120,121,122,123,124,125],"congestive heart failure","adipose-derived regenerative cells","left ventricular ejection fraction","lipoaspirate","retrograde intra-cardiac venous injection","Cardiac Magnetic Resonance Imaging","Cardiac Computer Tomography","end systolic volume","end diastolic volume","2024-11-28",{"date":128,"type":60},"2024-12-03",{"date":130,"type":60},"2024-11-18",{"date":132,"type":22},"2025-12-31",{"name":134,"class":99},"Ralf Rothoerl",1,{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":79,"phases":146,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":135},"100480339","coronary-artery-bypass-grafts-or-percutaneous-coronary-intervention-for-high-risk-patients-100480339","NCT05534698","Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for High Risk Patients","Coronary Artery Bypass Grafts or Percutaneous Coronary Intervention for Revascularization in Moderate to Highs Risk Patients With Ischemic Heart Disease and Reduced Left Ventricular Ejection Fraction","Inclusion Criteria:\n\n* Age ≥ 18 years\n\n  * LVEF\\\u003C45% with or without HF medication\n  * Heart team believes that a meaningful revascularization can be achieve both by PCI and by CABG\n  * Patients with severe CAD, where guidelines suggest equipoise between PCI and CABG\n\nExclusion Criteria:\n\n* Decompensated HF requiring inotropic\u002Fadrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump\u002F ventricular assist device therapy less than 48 hours prior to randomization\n\n  * Recent (\\\u003C 1 month) ST-elevation myocardial infarction\n  * Recent (\\\u003C 1 month) type 2 myocardial infarction ▪ Valvular heart disease or any other cardiac conditions (for example, left ventricular aneurysm) indicating the need for surgical repair\u002Freplacement\n  * Prohibitive bleeding risk or clinical scenario mandating avoidance of long-term dual antiplatelet therapy\n  * Pregnancy","100 Years",{"count":145,"type":22},1550,[147],"NA","Most patients with Left Ventricular Systolic Dysfunction (LVSD) or heart failure (HF) have coronary artery disease (CAD) while some patients also have renal disease. Life-saving revascularization is underperformed in patients with LVSD or HF due to CAD, and especially if there is concomitant renal disease. We hypothesize that PCI will be non-inferior to CABG for all-cause mortality and recurrent myocardial infarction (MI), stroke or hospitalization for HF. To compare revascularization by PCI versus by CABG, we will perform a multicentre, open-label, parallel, randomized, controlled trial in patients with severe CAD who belong to defined categories of moderate-to-high risk characteristics, where guidelines acknowledge that both PCI and CABG are relevant treatment options.",[150,28],"IHD","2022-09-11",{"date":153,"type":60},"2022-09-15",{"date":155,"type":22},"2022-10",{"date":157,"type":22},"2033-02",{"name":159,"class":160},"Danish Study Group","NETWORK"]