| Simdax (levosimendan IV) / AbbVie |
NCT00048425: Evaluation of Intravenous Levosimendan Efficacy in the Short Term Treatment of Decompensated Chronic Heart Failure. |
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| Completed | 3 | 600 | US, Canada, RoW | Levosimendan | Abbott, Orion Corporation, Orion Pharma | Heart Failure, Congestive | | 12/04 | | |
NCT00348504 / 2004-001225-16: Survival of Patients With Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomised, Double-Blind, Double-Dummy Study of Levosimendan Versus Dobutamine in Patients With Acute Heart Failure. |
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| Completed | 3 | 1300 | US | levosimendan, dobutamine | Abbott, Orion Corporation, Orion Pharma | Acute Heart Failure | | 06/05 | | |
NCT00166127: Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery |
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| Terminated | 3 | 1 | US | Levosimendan | Emory University, Abbott | Heart Failure | | 01/07 | | |
2007-004674-49: Levosimendan vor Herz-Lungen-Maschine bei Coronary artery bypass graft-Operationen |
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| Terminated | 3 | 100 | Europe | Simdax, Concentrate for solution for infusion, Simdax (R) | Charité - Universitätsmedizin Berlin | The drug Levosimendan / Simdax (R) will be investigated in patients undergoing coronary artery bypass graft operations. The study population will be patients with impaired myocardial function as stated with an ejection fraction equal or lower than 30 %. The study medication will be applied after establishing completed hemodynamic monitoring and maintained throughout the operation for twelve hours. | | | | |
| Unknown status | 3 | 120 | Europe | Levosimendan, Placebo | Medical University Innsbruck, Orion Corporation, Orion Pharma | Chronic Stable Heart Failure | 08/11 | 08/11 | | |
2012-005310-19: randomized clinical trial which included patients aged 1 month to 14 years who are to undergo cardiac surgery with high risk factors of postoperative acute heart failure to evaluate the efficacy and safety of levosimendan |
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| Ongoing | 3 | 36 | Europe | levosimendan, C01CX., Concentrate for solution for infusion, SIMDAX | FUNDACION PARA LA INVESTIGACIÓN BIOSANITARIA DE ANDALUCIA ORIENTAL_ FPA, Hospital Virgen de las Nieves | Children aged 1 month to 14 years in the health area of the province of Granada who will be undergoing heart surgery with a clinical high risk of developing acute heart failure after surgery, treated at the Unit Pediatric Intensive Care, University Hospital Virgen de las Nieves., Children with congenital heart disease that will be operate., Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | | | | |
| Terminated | 3 | 13 | Europe | Diuretics, Levosimendan | Niguarda Hospital, Orion Corporation, Orion Pharma | Advanced Chronic Heart Failure | 06/15 | 03/17 | | |
| Completed | 3 | 335 | Europe | levosimendan, Simdax, Placebo, riboflavine | Assistance Publique - Hôpitaux de Paris, Ministry of Health, France | Coronary Artery Bypass Grafting, Left Ventricular Dysfonction | 06/15 | 11/15 | | |
2005-004449-32: EFFECTIVENESS OF THE LEVOSIMENDAN IN THE THERAPY OF DIASTOLIC DYSFUNCTION OF CARDIAC SURGERY |
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| Ongoing | 3 | 60 | Europe | SIMDAX IV 1FL 5 ML 2,5 MG/ML, SIMDAX IV 1FL 5 ML 2,5 MG/ML | AZIENDA OSPEDALIERA OSPEDALI RIUNITI DI BERGAMO A.O. DI RILIEVO NAZIONALE | DIASTOLIC DYSFUNCTION OF CARDIAC SURGERY TREATMENT BEFORE SURGERY | | | | |
2007-007953-30: Levosimendan como agente inmunomodulador en la insuficiencia cardiaca aguda. Estudio PilotoLevosimendan as an immunomodulatory agent in acute heart failure. Pilot study. |
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| Ongoing | 3 | 60 | Europe | Simdax, Simdax | Fundación Investigación y Desarrollo en el Área Cardiovascular | Analysis of the short-term treatment with levosimendan, a cardiac stimulant drug, of the acute exacerbation of chronic heart failureEstudio del tratamiento a corto plazo con levosimendan, fármaco estimulante cardiaco, de la descompensación aguda de la insuficiencia cardiaca crónica | | | | |
LEVO-CTS, NCT02025621: Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass |
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| Completed | 3 | 882 | US, Canada | Levosimendan, Simdax, Placebo | Tenax Therapeutics, Inc. | Coronary Artery Bypass Grafting, Mitral Valve Surgery, Low Cardiac Output Syndrome | 11/16 | 11/16 | | |
| Completed | 3 | 33 | Europe | Levosimendan, Simdax, Dobutamine, Dobutrex | Göteborg University, Sahlgrenska University Hospital, Sweden | Cardiorenal Syndrome | 05/17 | 05/17 | | |
LeoDOR, NCT03437226: Repetitive Levosimendan Infusion for Patients With Advanced Chronic Heart Failure |
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| Unknown status | 3 | 264 | Europe | Levosimendan 2.5 MG/ML, Simdax, Orion Pharma, Espoo, Finland, Placebos, Placebo Levosimendan infusion concentrate | Dr. Gerhard Pölzl, Orion Corporation, Orion Pharma | Heart Failure | 04/19 | 12/19 | | |
2018-004063-31: Use of levosimendan / placebo as cardio and nephroprotection in patients who are going 0n cardiac surgery with right ventricular dysfunction Uso de levosimendán / placebo como cardio y nefroprotector en pacientes que van a ser operadosde disfunción cardiaca derecha |
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| Ongoing | 3 | 20 | Europe | Levosimendan, Concentrate and solvent for solution for injection/infusion, LEVOSIMENDAN | Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS), Anestesioloy and Reanimation Unit | Perioperative right ventricle dysfunction Disfunción de ventrículo derecho perioperatoria, Right ventricle dysfunction Alteración ventrículo derecho, Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] | | | | |
| Unknown status | 3 | 184 | Europe | Levosimendan, Placebos | Hospital Universitario de Canarias | ST Elevation Myocardial Infarction | 04/20 | 12/21 | | |
2019-004319-29: " LEVOSIMENDAN to facilitate weaning from ECMO in severe cardiogenic shock patients LEVOSIMENDAN afin de faciliter le sevrage de l'ECMO chez les patients présentant un choc cardiogénique sévère |
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| Completed | 3 | 206 | Europe | ZIMINO 12.5 mg (levosimendan) 2,5 mg/ml, Solution for infusion, ZIMINO 12.5 mg (levosimendan) 2,5 mg/ml | ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP), DGOS | Adult patients with acute cardiogenic shock refractory to conventional therapy placed on VA-ECMO support and for whom withdrawal from ECMO is possible. Patients adultes assistés par VA-ECMO pour choc cardiogénique réfractaire au traitement conventionnel et pour lesquels un sevrage de l’ECMO est envisageable., Adult patients with acute cardiogenic shock refractory to conventional therapy placed on VA-ECMO support and for whom withdrawal from ECMO is possible. Patients adultes assistés par VA-ECMO pour choc cardiogénique réfractaire au traitement conventionnel et pour lesquels un sevrage de l’ECMO est envisageable., Diseases [C] - Cardiovascular Diseases [C14] | | | | |
NCT04020003: A Clinical Study on Levosimendan Improvement of Prognosis of ARDS Patients by Optimizing Pulmonary Hemodynamics |
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| Unknown status | 3 | 120 | RoW | Levosimendan | Shenzhen Second People's Hospital | ARDS, Human | 12/21 | 08/22 | | |
2017-002429-39: REPETITIVE LEVOSIMENDAN INFUSIONS FOR PATIENTS WITH ADVANCED CHRONIC HEART FAILURE |
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| Completed | 3 | 264 | Europe | Simdax, [Levosimendan], Concentrate and solvent for solution for infusion, Simdax 2,5mg/ml | Medical University Innsbruck, Orion Pharma, ORION Pharma | Advanced chronic heart failure, Advanced chronic heart failure, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
NCT03555123: Evaluate the Efficacy and Safety of Short-term Administration of SIMDAX |
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| Recruiting | 3 | 112 | RoW | Simdax | Yooyoung Pharmaceutical Co., Ltd. | Acute Decompensated Heart Failure | 01/22 | 07/22 | | |
2020-005600-19: LEvOsimendaN vs. Placebo Before Tricuspid VAlve Surgery in Patients with Right Ventricular Dysfunction |
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| Not yet recruiting | 3 | 230 | Europe | ZIMINO, Concentrate for solution for infusion, ZIMINO 12,5 mg | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS | Patients referred for an isolated or a combined surgical correction of functional moderate to severe tricuspid regurgitation | | | | |
IMPROVE, NCT04329624: Effect Levosimendan Administration on Postoperative NT-proBNP in Cardiac Risk Patients |
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| Completed | 3 | 230 | Europe | Levosimendan, Placebo | Medical University of Vienna | Cardiovascular Risk Factor | 11/23 | 12/24 | | |
Weanilevo, NCT04158674: Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS |
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| Terminated | 3 | 82 | Europe | Levosimendan, Cernevit | Centre Hospitalier Universitaire Dijon | Acute Decompensated Heart Failure | 10/23 | 10/23 | | |
2022-003628-42: Study of Levosimendan Therapy in low ejection fraction Takotsubo Syndrome |
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| Not yet recruiting | 3 | 190 | Europe | Simdax, Concentrate for solution for infusion, Simdax | Medical University of Gdańsk, Medical Research Agency | Takotsubo syndrome (TTS), also known as apical ballooning syndrome, Takotsubo cardiomyopathy, broken heart syndrome, and stress-induced cardiomyopathy, is a rare condition and accounts for 1–3% of all patients referred to hemodynamic laboratories with a primary diagnosis of acute coronary syndrome (ACS)., Takotsubo syndrome, Diseases [C] - Cardiovascular Diseases [C14] | | | | |
| Recruiting | 3 | 610 | Europe | Levosimendan 2.5 MG/ML Injectable Solution, Placebo | Pr Bruno LEVY | Cardiogenic Shock | 02/27 | 01/28 | | |
| Completed | 3 | 206 | Europe | Levosimendan, Placebo of Levosimendan | Assistance Publique - Hôpitaux de Paris | Cardiogenic Shock, Extracorporeal Membrane Oxygenation Complication | 11/24 | 11/24 | | |
NCT06478667: The Role of Levosimendan as Inotropic Agent in Acute Aluminum Phosphide-induced Cardiotoxicity |
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| Completed | 3 | 50 | RoW | levosemindan | Ain Shams University | Acute Myocarditis | 01/25 | 01/25 | | |
LEONARD, NCT05233202: Levosimendan Versus Placebo Before Tricuspid Valve Surgery in Patients With Right Ventricular Dysfunction |
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| Recruiting | 3 | 230 | Europe | Levosimendan, Experimental arm, PLACEBO, Control arm | Assistance Publique - Hôpitaux de Paris | Patients Referred for an Isolated or a Combined Surgical Correction of Functional Moderate to Severe Tricuspid | 01/25 | 01/25 | | |
2004-002653-31: CAPHI. Profylactic effect of Ca2+ sensitizer versus phosphodiesterase inhibitor infusion at CAGB patients with preoperative low ejection fraction. A prospective randomised clinical trial. |
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| Completed | 3 | 40 | Europe | simdax, corotrop, 970223, Concentrate for solution for infusion, Simdax, Corotrop | Odense University hospital | Perioperative use of Milrinon to CAGB patients has shown to reduce postoperative complications. Levosimendan improves cardiac performance without interfering with the calcium turnover and there by use of cellular energi. This study wants to document a better cardiac performance in CABG patients with preoperative low ejection fraction EF after prophylactic calcium sensitizer- versus phosphodiesterase-infusion in a double-blinded randomised clinical trial. | | | | |
| Recruiting | 3 | 540 | Europe, US, RoW | TNX-103, Placebo | Tenax Therapeutics, Inc. | Pulmonary Hypertension Associated With HFpEF | 06/28 | 06/29 | | |
NCT05983250: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF |
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| Recruiting | 3 | 230 | Canada, US | TNX-103, Placebo | Tenax Therapeutics, Inc., Medpace, Inc., Northwestern University | Pulmonary Hypertension | 10/26 | 10/28 | | |
NCT00093301: Levosimendan Versus Dobutamine in Shock Patients |
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| Unknown status | 2/3 | 40 | RoW | Levosimendan, Dobutamine | Wentworth Area Health Services, Abbott | Cardiogenic Shock, Septic Shock | | 04/06 | | |
NCT01721434: Effects of Levosimendan on Diaphragm Function in Mechanically Ventilated Patients |
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| Unknown status | 2/3 | 42 | Europe | Levosimendan, Simdax, Placebo | University Medical Center Nijmegen, Orion Corporation, Orion Pharma | Muscle Weakness Conditions, Weaning Failure | 05/16 | 05/16 | | |
| Unknown status | 2/3 | 68 | Europe | Levosimendan, Simdax (R), Conventional therapy, Standard care plus placebo comparator | VieCuri Medical Centre, Orion Corporation, Orion Pharma | Acute Kidney Injury | 10/17 | 10/17 | | |
| Recruiting | 2/3 | 300 | Europe | Levosimendan, SIMDAX, Placebos | María de los Ángeles Tena Pajuelo, Orion Corporation, Orion Pharma, Canary Foundation, Dr Negrin Hospital Statistician, Dr Negrin Hospital Farmacy, CRO TRIDE Asesores SL, QBE Europe SA/NV | Cardiac Output, Low | 01/22 | 12/22 | | |
NCT05768230: Using TEE to Evaluate the Effect of Levosimendan on Patients With ARDS Associated With RVD During MV |
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| Not yet recruiting | 2/3 | 58 | RoW | levosimendan, 5% glucose injection | Wuhan Union Hospital, China | Transesophageal Echocardiography, Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction | 12/25 | 12/25 | | |
NCT07262723: Levosimendan in Acute Decompensated Heart Failure |
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| Not yet recruiting | 2/3 | 332 | RoW | Levosimendan, Standard care | Chittagong Medical College, Beacon Pharmaceuticals PLC, Pi Research and Development Center, Bangladesh | Acute Decompensated Heart Failure (ADHF) | 10/26 | 12/26 | | |
