Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2026-03-01 @ 12:19 AM
Study NCT ID:
NCT01748006
Status:
UNKNOWN
Last Update Posted:
2015-10-28
First Post:
2012-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and urine analyses'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-26', 'studyFirstSubmitDate': '2012-08-15', 'studyFirstSubmitQcDate': '2012-12-10', 'lastUpdatePostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The correlation between levels of plasma copeptin and vasopressin with left ventricular filling pressure and cardiac output', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'The correlation between levels of plasma copeptin and vasopressin with urine aquaporin-2 concentration', 'timeFrame': 'Day 1'}, {'measure': 'The correlation between New York Heart Association (NYHA) class and levels of plasma copeptin and vasopressin', 'timeFrame': 'Day 1'}, {'measure': 'The correlation between biomarkers levels and survival free of transplantation- and left ventricular assist device insertion', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '30058349', 'type': 'DERIVED', 'citation': 'Balling L, Goetze JP, Jung MH, Rossing K, Boesgaard S, Gustafsson F. Copeptin levels and invasive hemodynamics in patients with advanced heart failure. Biomark Med. 2018 Aug;12(8):861-870. doi: 10.2217/bmm-2017-0439. Epub 2018 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'The relationship between the activation of the vasopressin system and central hemodynamics in heart failure (including right and left heart filling pressures and cardiac output) is not clear. The investigators intend to examine the correlation between levels of copeptin and vasopressin and the central hemodynamic system in patients with advanced (class III or IV) heart failure. The investigators also aim to examine the relationship of selected cardiac biomarkers in blood and urine with cardiac filling pressures and cardiac output in patients with decompensated heart failure.\n\nThe study population will consist of 30 patients admitted to the Department of Cardiology at Copenhagen University Hospital. Only patients for whom the attending cardiologist has already decided upon right heart catheterization for clinical/treatment reasons will be recruited for the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of 30 patients with heart failure admitted to the Department of Cardiology at the Copenhagen University Hospital, Rigshospitalet,Dennmark. Only patients who are already referred to right heart catheterization by the attending cardiologist will be recruited for the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Left ventricular ejection fraction \\< 40 %\n3. Diagnosed symptomatic heart failure treated with heart failure medications for at least 30 days.\n4. Clinical indication for right heart catheterization for clinical/treatment reasons\n5. NYHA-class III-IV\n6. Relevant heart failure treatment as tolerated by the patient\n\nExclusion Criteria:\n\n1. Absence of clinical/treatment indication of right heart catheterization\n2. Syndrome of Inappropriate Secretion of ADH (SIADH)\n3. Recent acute myocardial infarction within the last 30 days\n4. Presence of infection or inflammatory disease\n5. Malignant disease\n6. Pregnancy\n7. Subjects unwilling or unable to provide written consent'}, 'identificationModule': {'nctId': 'NCT01748006', 'briefTitle': 'The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Correlation Between Filling Pressure, Cardiac Output and Plasma Copeptin in Patients With Systolic Heart Failure', 'orgStudyIdInfo': {'id': 'H-1-2012-019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Blood and urine samples', 'interventionNames': ['Other: Standard of care therapy for severe decompensated heart failure']}], 'interventions': [{'name': 'Standard of care therapy for severe decompensated heart failure', 'type': 'OTHER', 'armGroupLabels': ['Blood and urine samples']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Finn Gustafsson, MD, PhD, DMSc', 'role': 'CONTACT', 'email': 'finng@dadlnet.dk', 'phone': '004535459743'}, {'name': 'Louise Balling, MD', 'role': 'CONTACT', 'email': 'louise.balling@dadlnet.dk', 'phone': '004535452142'}, {'name': 'Finn Gustafsson, MD, PhD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Cardiology, Copenhagen University Hospital, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Finn Gustafsson, MD, DMSc', 'role': 'CONTACT', 'email': 'finng@dadlnet.dk', 'phone': '004535459743'}, {'name': 'Louise Balling, MD', 'role': 'CONTACT', 'email': 'louise.balling@dadlnet.dk', 'phone': '004535452142'}], 'overallOfficials': [{'name': 'Finn Gustafsson, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finn Gustafsson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, DMSc', 'investigatorFullName': 'Finn Gustafsson', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}