Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT06205758
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2024-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2024-01-04', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of adverse reactions', 'timeFrame': '30-days', 'description': 'Incidence of adverse reactions, including headache, hypotension, and cardiac arrhythmias.'}], 'primaryOutcomes': [{'measure': 'Adverse outcome events', 'timeFrame': '30-days', 'description': 'Adverse outcome events (within 30 days) included mortality, unplanned readmission, transfer to ICU, and resuscitation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute and advanced heart failure', 'Milrinone', 'Levosimendan', 'renal insufficiency'], 'conditions': ['Heart Failure', 'Levosimendan', 'Milrinone', 'Efficacy', 'Safety']}, 'descriptionModule': {'briefSummary': '1. To evaluate the efficacy and safety of levosimendan and milrinone in the treatment of with acute heart failure with or without renal dysfunction;\n2. Predictive modeling of the efficacy and safety of levosimendan and milrinone.', 'detailedDescription': 'By comparing the safety and efficacy of milrinone with levosimendan as an initial inotropic agent for the treatment of patients with acute heart failure with or without abnormal renal function, a preliminary efficacy and safety prediction model was developed for levosimendan and milrinone based on the basic characteristics of the patients and the level of renal function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute heart failure (AHF), including new-onset acute heart failure AHF and acute decompensated chronic heart failure (ADHF), is usually associated with either mild or severe renal impairment. Deterioration of renal function can lead to a serious prognosis. Milrinone and levosimendan are the most commonly prescribed inotropic drugs with preclinical and clinical evidence of their renoprotective effects.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old\n* Patients who were clearly diagnosed with heart failure ( cardiac insufficiency ) and LVEF(Left Ventricular Ejection Fraction) \\< 50 %, and were judged by the physician to need and agree to use levosimendan or milrinone to maintain hemodynamic stability\n\nExclusion Criteria:\n\n* chronic heart failure and New York Heart Association ( NYHA ) class I \\~ II\n* Complicated with infective endocarditis, aortic dissection, severe liver dysfunction ( child-pugh C ), severe renal insufficiency ( CrCl \\< 30 ml / min ), hypertrophic obstructive cardiomyopathy, ventricular assist device or surgical cardiac surgery within 30 days before the use of levosimendan\n* Patients with severe ventricular arrhythmia 1 within 24 hours before levosimendan and systolic blood pressure 100 times / min within 2 hours before levosimendan\n* During hospitalization, other positive inotropic drugs 2 were used when levosimendan was intravenously pumped or dripped, excluding the use of catecholamines for rescue\n* received positive inotropic drug 2 treatment in the last 30 days\n* Lack of serum creatinine, brain natriuretic peptide or brain natriuretic peptide precursor, serum total bilirubin, cardiac ultrasound baseline ( within 14 days before using levosimendan ) data\n* pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT06205758', 'briefTitle': 'Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Efficacy and Safety Prediction of Milrinone or Levosimendan as Initial Inotropic Drug Therapy in Patients With Acute and Advanced Heart Failure With Renal Insufficiency', 'orgStudyIdInfo': {'id': 'LM001'}}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Han, doctorate', 'role': 'CONTACT', 'email': '15552565120@163.com', 'phone': '15552565120'}], 'facility': 'First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yi Han, doctorate', 'role': 'CONTACT', 'email': '15552565120@163.com', 'phone': '15552565120'}], 'overallOfficials': [{'name': 'Yi Han, doctorate', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Shandon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yi Han', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qianfoshan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor of pharmacy', 'investigatorFullName': 'Yi Han', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}