[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613141":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":137,"collaborators":140,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":26,"eligibilityCriteria":152,"healthyVolunteers":148,"sex":153,"minAge":154,"maxAge":26,"enrollmentInfo":155,"targetDuration":26,"studyType":158,"phases":159,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":176,"whyStopped":26,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},{"fullName":5,"class":6},"Chittagong Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","Participants will receive standard guideline-directed care for heart failure plus levosimendan infusion. Levosimendan will be administered as a continuous intravenous infusion at 0.1 μg\u002Fkg\u002Fmin for 24 hours, in addition to standard therapy.",[13],"Drug: Levosimendan",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care","ACTIVE_COMPARATOR","Participants will receive standard guideline-directed care for heart failure according to the 2024 ACC guidelines. This may include diuretics, vasodilators, inotropes, and other evidence-based therapies as clinically indicated.",[19],"Other: Standard care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Levosimendan","Levosimendan is a calcium-sensitizing inotrope with vasodilatory effects, enhancing heart contractility without raising oxygen demand and promoting vascular relaxation. In this trial, patients will be randomized to receive either standard care alone or standard care plus levosimendan (0.1 μg\u002Fkg\u002Fmin IV infusion for 24 hours).",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard care","Participants will receive standard care for acute decompensated heart failure according to the 2024 ACC Guideline for the Management of Heart Failure. This may include intravenous diuretics, vasodilators, inotropes, renin-angiotensin system inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors as clinically indicated.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mohammad Jahid Hasan, MBBS, MPH","CONTACT","8801767818973","dr.jahid61@gmail.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Tamanna Tabassum, MBBS, MPH","+8801755383138","dr.tabassum1991@gmail.com",[42,62,76,88,103,124],{"facility":43,"status":26,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Chittagong Medical College Hospital, Chattogram","Chittagong","4000","Bangladesh","BD",{"type":49,"coordinates":50},"Point",[51,52],91.83168,22.3384,{"lat":52,"lon":51},[55,59],{"name":56,"role":34,"phone":57,"phoneExt":26,"email":58},"Mohammad Nur Uddin Tareq","+8801718225723","tareq_ccu@yahoo.com",{"name":60,"role":61,"phone":26,"phoneExt":26,"email":26},"Anisul Awal, FCPS, MCPS, MD, MBBS","PRINCIPAL_INVESTIGATOR",{"facility":63,"status":26,"city":44,"state":26,"zip":64,"country":46,"countryCode":47,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"Chattogram Maa-O-Shishu Hospital Medical College Hospital","4100",{"type":49,"coordinates":66},[51,52],{"lat":52,"lon":51},[69,73],{"name":70,"role":34,"phone":71,"phoneExt":26,"email":72},"Md. Abu Tarek Iqbal","+8801711107987","drtarekiqbal@yahoo.com",{"name":74,"role":75,"phone":26,"phoneExt":26,"email":26},"Md. Abu Tarek Iqbal, D card, MD (Med), MD (card)","SUB_INVESTIGATOR",{"facility":77,"status":26,"city":44,"state":26,"zip":78,"country":46,"countryCode":47,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"Apollo Imperial Hospital & Max Hospital","4202",{"type":49,"coordinates":80},[51,52],{"lat":52,"lon":51},[83,87],{"name":84,"role":34,"phone":85,"phoneExt":26,"email":86},"Asish Dey, MBBS, FCPS (Medicine)","+8801819329499","dey_asish@yahoo.com",{"name":84,"role":75,"phone":26,"phoneExt":26,"email":26},{"facility":89,"status":26,"city":90,"state":26,"zip":91,"country":46,"countryCode":47,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Cox's Bazar Medical College","Cox’s Bāzār","4700",{"type":49,"coordinates":93},[94,95],92.00955,21.43973,{"lat":95,"lon":94},[98,102],{"name":99,"role":34,"phone":100,"phoneExt":26,"email":101},"Biplob Bhattacharjee, MBBS, D Card, MD","+8801713066414","bsnrid@gmail.com",{"name":99,"role":75,"phone":26,"phoneExt":26,"email":26},{"facility":104,"status":26,"city":105,"state":26,"zip":106,"country":46,"countryCode":47,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"National Institute of Cardiovascular Diseases","Dhaka","1207",{"type":49,"coordinates":108},[109,110],90.40744,23.7104,{"lat":110,"lon":109},[113,117,118,120,122],{"name":114,"role":34,"phone":115,"phoneExt":26,"email":116},"Mohammad Ullah Firoze, FCPS, MD","+8801819443140","firoze1970@gmail.com",{"name":114,"role":75,"phone":26,"phoneExt":26,"email":26},{"name":119,"role":75,"phone":26,"phoneExt":26,"email":26},"Sabina Hashem",{"name":121,"role":75,"phone":26,"phoneExt":26,"email":26},"Abdul Momen, FCPS, MD",{"name":123,"role":75,"phone":26,"phoneExt":26,"email":26},"Lima Asrin Sayami, FCPS (Cardiology) MRCP",{"facility":125,"status":26,"city":105,"state":26,"zip":126,"country":46,"countryCode":47,"cosmosGeoPoint":127,"geoPoint":129,"contacts":130},"United Hospital Limited","1212",{"type":49,"coordinates":128},[109,110],{"lat":110,"lon":109},[131,135],{"name":132,"role":34,"phone":133,"phoneExt":26,"email":134},"A. M. Shafique","+8801715011421","amscard@gmail.com",{"name":136,"role":75,"phone":26,"phoneExt":26,"email":26},"Kaisar Nasrullah Khan",{"type":61,"investigatorFullName":138,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Anisul Awal","Associate Professor, Department of Cardiology",[141,144],{"name":142,"class":143},"Beacon Pharmaceuticals PLC","UNKNOWN",{"name":145,"class":143},"Pi Research and Development Center, Bangladesh","100613141","phase-2-levosimendan-in-acute-decompensated-heart-failure-100613141",false,"NCT07262723","Levosimendan in Acute Decompensated Heart Failure","Efficacy and Safety of Levosimendan in Patients With Acute Decompensated Heart Failure: A Real-World Evidence","Inclusion Criteria:\n\n* Adult patients (age \\>18 years)\n* Both male and female sex\n* Having left ventricular dysfunction, evidenced by a left ventricular ejection fraction \\\u003C40% within the prior 12 months\n* Hospitalized for the treatment of ADHF\n* Remained dyspneic at rest despite treatment with intravenous diuretics (NYHA class IV)\n* Patients might have received intravenous vasodilators and\u002For positive inotropic drugs (except amrinone and milrinone), but the infusion rates of these drugs must have remained constant for at least 2 h before entry into the study.\n\nExclusion Criteria:\n\n* History of invasive cardiac procedure\n\n  * Cardiac surgery during lifetime within 3 months prior to screening\n  * Cardiac revascularization within 3 months prior to screening\n  * Left ventricular assist device (LVAD) implantation within 3 months prior to screening\n  * A cardioversion within 4 h prior to screening, or\n  * Cardiac re-synchronization procedure within 30 days prior to screening)\n* Rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate)\n* Severe ventricular outflow obstruction\n* Angina within 6 h prior to screening\n* Hypotension (a systolic blood pressure \\\u003C90 mmHg) \\[Can be included after resuscitation, when SBP will be \\>90 mmHg by noradrenaline infusion\\]\n* Uncorrected hypokalemia\n* CNS disease (e.g. stroke, TIA)\n* Respiratory (e.g. COPD exacerbation requiring systematic steroids or intubation)\n* Renal insufficiency (e.g. increased serum creatinine clearance rate \\\u003C15 mL\u002Fmin)\n* Hepatic impairment (e.g. significant increase in liver enzymes, \\>5x the upper limit of normal)\n* Decompensation from active infection eg, sepsis\n* Acute bleeding\n* Patient required blood transfusion or Severe anemia (hemoglobin \\\u003C8 g\u002Fl)\n* Serum potassium concentration \\\u003C3.5 or \\>5.4 mmol\u002Fl\n* Use of amrinone and milrinone prior to screening\n* A history of hypersensitivity to levosimendan or any of the excipients\n* Intubated or otherwise unable to communicate\n* Pregnancy\n* Post partum cardiomyopathy\n* Previous participation in a clinical trial with any experimental treatment within the last 30 days","ALL","18 Years",{"count":156,"type":157},332,"ESTIMATED","INTERVENTIONAL",[160,161],"PHASE2","PHASE3","Acute decompensated heart failure (ADHF) is one of the major causes of hospitalization and mortality worldwide. Despite advances in medical treatments, managing ADHF remains complex, especially in high-risk populations. Levosimendan, a calcium sensitizer that improves myocardial contractility and reduces complications associated with acute decompensated heart failure, has shown potential in improving outcomes in these patients. The present study aims to evaluate the efficacy and safety of levosimendan in patients with ADHF in a real-world clinical setting.\n\nThis pragmatic, multicenter, randomized, controlled trial will include adult patients diagnosed with ADHF in two groups: one receiving levosimendan infusion, and the other receiving standard care for heart failure management, according to the most up-to-date clinical protocols. The study is designed to assess both the efficacy and safety of levosimendan, comparing it with the current standard of care.\n\nThe primary endpoint of the study will be a clinical composite outcome measured from the NYHA functional classification of heart failure and patient global assessment. Secondary endpoints will include change in serum pro-BNP levels, clinical outcome of heart failure, changes in dyspnea status, all-cause and cardiac mortality. Safety endpoints, including adverse events, will also be systematically recorded and analyzed. Adverse events will be closely monitored, categorized as either mild, moderate, or severe, and their potential association with the treatment will be assessed.\n\nData collection will occur at baseline and during subsequent follow-up visits at 6 hours, 24 hours, 5 days (or day of discharge), and 90 days post-treatment. Key efficacy measures will be obtained through clinical evaluations and laboratory tests, including blood pressure, electrocardiogram (ECG) findings, and NT-proBNP serum levels. The statistical analysis will follow an intention-to-treat (ITT) and Per protocol (PP) approach to account for all enrolled patients, ensuring robust and generalizable findings. This study will be conducted in accordance with Good Clinical Practice (GCP) guidelines and ethical standards outlined in the Declaration of Helsinki, prioritizing participant safety and scientific rigor throughout the study.\n\n12 The results of this trial will provide critical insights into the potential benefits of levosimendan for treating ADHF, and could potentially inform clinical decision-making, offering a more effective therapeutic option in managing this life-threatening condition.",[164],"Acute Decompensated Heart Failure (ADHF)",[166,23,167,168,169,170,171,172,173,174,175],"Acute decompensated heart failure (ADHF)","Real-world evidence","Efficacy","Safety","NT-proBNP \u002F pro-BNP levels","Randomized controlled trial (RCT)","Electrocardiogram (ECG)","Good Clinical Practice (GCP)","Declaration of Helsinki","Adverse events","NOT_YET_RECRUITING","2025-11-23",{"date":179,"type":180},"2025-12-04","ACTUAL",{"date":182,"type":157},"2025-12-01",{"date":184,"type":157},"2026-12-30",{"name":5,"class":6},6]