[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621930":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":37,"locations":46,"responsibleParty":74,"collaborators":18,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":18,"enrollmentInfo":87,"targetDuration":18,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":101,"whyStopped":18,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pulsatile compression boots (PCB)","EXPERIMENTAL","Receives sessions with PCB (YourBoots, CE approved), as an add on intervention during the entire hospital stay. The PCB intervention will be blinded for the treating clinicians as far as possible in a clinical setting. Furthermore, the study will not interfere with the treating clinician' choice of treatment in general.",[13],"Device: Pulsatile Compression Boots (PCB)",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","NO_INTERVENTION","Receives either no non-pharmacological treatment or the non-pharmacological treatment chosen by the clinician (e.g. compression bandages), but no compression boots.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Pulsatile Compression Boots (PCB)","Each boot has eight chambers that can be inflated to between 30 and 240 mmHg. The first chamber that inflates is at ankle level. When this chamber has achieved the predefined pressure for 17 seconds, the next proximal chamber (chamber two) inflates while the pressure in the distal (ankle) chamber is maintained at constant pressure. This sequence continues until the most proximal chamber at the thigh (chamber eight) has been inflated and has held the maximum pressure for 17 seconds. Thereafter, all the chambers open to release the air, and there is a pause for 30 seconds. The sequence then starts again and continues for 30 minutes. This 30-minute sequence is termed one \"session\". Pulsatile compression therapy will be applied three sessions per day.",[9],[26,27,28,29,30,31],"Pneumatic compression boots","Intermittent pneumatic compression boots","Sequential compression boots","Pneumatic compression devices","Dynamic compression boots","Pulsatile compression therapy",[33],{"name":34,"affiliation":35,"role":36},"Freja S. Madsen, M.D., Ph.D student","Cardiovascular Research Unit, OUH, Svendborg","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":18,"email":41},"CONTACT","+4522111245","freja.sonder.madsen@rsyd.dk",{"name":43,"role":39,"phone":44,"phoneExt":18,"email":45},"Jess Lambrechtsen, Professor","004563202402","Jess.Lambrechtsen@rsyd.dk",[47],{"facility":48,"status":18,"city":49,"state":18,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Cardiovascular Research Unit. Odense University Hospital, Svendborg.","Svendborg","5700","Denmark","DK",{"type":54,"coordinates":55},"Point",[56,57],10.60677,55.05982,{"lat":57,"lon":56},[60,63,64,66,68,70,72],{"name":61,"role":39,"phone":62,"phoneExt":18,"email":41},"Freja S. Madsen, M.D., Ph.D. student","004522111245",{"name":43,"role":39,"phone":18,"phoneExt":18,"email":45},{"name":65,"role":36,"phone":18,"phoneExt":18,"email":18},"Freja Sønder Madsen, M.D., Ph.D student",{"name":43,"role":67,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"name":69,"role":67,"phone":18,"phoneExt":18,"email":18},"Søren Auscher, Post.Doc",{"name":71,"role":67,"phone":18,"phoneExt":18,"email":18},"Jacob Eifer Møller, Professor",{"name":73,"role":67,"phone":18,"phoneExt":18,"email":18},"Casper Falster, M.D., Ph.D.",{"type":36,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Freja Sønder Madsen","Principal investigator, MD","100621930","efficacy-and-safety-of-compression-boots-in-patients-with-acute-decompensated-heart-failure-100621930",false,"NCT07377019","Efficacy and Safety of Compression Boots in Patients With Acute Decompensated Heart Failure.","The Efficacy and Safety of Pulsatile Compression Boots in Patients With Acute Decompensated Heart Failure. A Randomized, Controlled Trial.","COMPLEX","Inclusion Criteria:\n\n* Capable of giving written informed consent\n* Inclusion within 24 hours from admission\n* Bilateral LE edema - defined as: Pitting edema scale \\> 1, bilaterally\n* Initial IV diuretic treatment\n\nEvidence of heart failure - at least one of the following:\n\n1. Heart failure with reduced ejection fraction (HFrEF):\n\n   * Signs and\u002For symptoms of HF\n   * Left ventricular ejection fraction (LVEF) ≤ 40%\n2. Heart failure with mildly reduced ejection fraction (HFmrEF):\n\n   * Signs and\u002For symptoms of HF\n   * LVEF 41 - 49%\n3. Heart failure with preserved ejection fraction (HFpEF):\n\n   * Signs and\u002For symptoms of HF\n   * LVEF ≥ 50 %\n   * Evidence of structural heart disease (Left atrial enlargement or left ventricular hypertrophy)\n   * NT-proBNP \\> 300pg\u002FmL for patients without ongoing atrial fibrillation\u002Fflutter, and NT-proBNP \\> 600 pg\u002FmL for patients with ongoing atrial fibrillation\u002Fflutter.\n\nEvidence of elevated pulmonary artery pressure - at least one of the following:\n\n* Systolic pulmonary artery pressure (sPAP) \\> 35 mmHg\n* Tricuspid regurgitation gradient (TRG) \\> 30 mmHg\n* Severe tricuspid regurgitation and VCI \\> 20 mm.\n\nAdditional echocardiographic criteria:\n\n\\- Left atrial end-systolic volume index \\> 34 mL\u002Fm2\n\nExclusion Criteria:\n\n* Pregnancy\n* Life expectancy less than 1 year for any reason\n* Expected hospital stay less than 1 day\n* New York Heart Association classification (NYHA) class IV\n* LVEF \\\u003C 20%\n* Diastolic left ventricular diameter \\> 70 mm\n* Known history or symptoms of peripheral arterial disease (Intermittent claudication or brachial-ankle index with value \\\u003C 0,9)\n* Significant leg wounds or infections\n* Deep venous thrombosis (DVT)\n* Need for treatment with inotropes or vasopressors\n* Permanent dialysis\n* Manifest acute kidney injury with oliguria\n* Current high-pressure pulmonary edema","ALL","18 Years",{"count":88,"type":89},100,"ESTIMATED","INTERVENTIONAL",[92],"NA","The aim of this clinical trial is to investigate whether pulsatile compression therapy can support heart and kidney function in patients admitted with acute heart failure and fluid accumulation in the legs.\n\nPulsatile compression boots, which provide pulsatile compression therapy, work by adding a predefined pressure to the legs in a rhythm that enhances mobilization of peripheral edema and improves venous and lymphatic drainage from the lower extremities. This increased venous return (preload) may allow the heart to fill more effectively and pump more strongly, thereby improving circulation. Better circulation can enhance kidney blood flow, help diuretics work more efficiently, and reduce the risk of complications due to worsening heart failure, affecting both the heart and kidneys.\n\nThe investigators want to explore whether adding this therapy to standard diuretic treatment is safe, feasible, and offers benefits compared with standard diuretic treatment alone.\n\nParticipants will receive three daily sessions of pulsatile compression therapy alongside usual clinical care.",[95],"Acute Decompensated Heart Failure (ADHF)",[97,98,99,100],"Acute Decompensated Heart Failure","Heart failure","Compression therapy","Cardiorenal syndrome","NOT_YET_RECRUITING","2026-01-21",{"date":104,"type":105},"2026-01-29","ACTUAL",{"date":107,"type":89},"2026-01",{"date":109,"type":89},"2028-04",{"name":5,"class":6},1]