Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-29 @ 5:33 PM
Study NCT ID:
NCT01179061
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2010-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Inotropic Potential of Apelin
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073861', 'term': 'Apelin'}], 'ancestors': [{'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2010-08-09', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cardiac output', 'timeFrame': '6 hours', 'description': 'We will assess, using thoracic bioimpedance cardiography, the change in cardiac output in response to apelin infusion'}], 'secondaryOutcomes': [{'measure': 'Urine volume', 'timeFrame': '6 hours', 'description': 'All urine will be collected during the studya and we will assess volume and relevant biochemical/humoral factors'}, {'measure': 'Pulmonary artery pressure', 'timeFrame': '1 hour', 'description': 'Using echocardiography we will estimate the pulmaonary artery pressure from pulmonary velocity and assess any change during the first hour of study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Apelin', 'Heart failure', 'Pulmonary artery pressure', 'Inotropic', 'Diuretic'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '23519586', 'type': 'DERIVED', 'citation': 'Barnes GD, Alam S, Carter G, Pedersen CM, Lee KM, Hubbard TJ, Veitch S, Jeong H, White A, Cruden NL, Huson L, Japp AG, Newby DE. Sustained cardiovascular actions of APJ agonism during renin-angiotensin system activation and in patients with heart failure. Circ Heart Fail. 2013 May;6(3):482-91. doi: 10.1161/CIRCHEARTFAILURE.111.000077. Epub 2013 Mar 21.'}]}, 'descriptionModule': {'briefSummary': "The apelin-APJ system is a recently discover hormone system that has several important actions in the cardiovascular system. Apelin causes the heart pump with more force and also causes blood vessels to relax. Studies to date show that people with reduced pumping function of the heart have lower levels of apelin in the bloodstream compared to people with normal heart function. We have previously given apelin to healthy volunteers and people with reduced pumping function and this increases the heart's contraction. However, this has only been assessed over a short time period, around fifteen minutes, and we now want to know if this effect is seen over a longer period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy volunteers:\n\n\\>18yrs\n\nHeart failure patients;\n\n* New York Heart Failure class II-IV\n* Ejection fractional \\<35% or fractional shortening \\<20% within previous 6months.\n\nExclusion Criteria:\n\nAll subjects,\n\n* Females of child bearing age not on adequate contraception\n* Lack of informed consent\n* Age \\<18yrs\n* Current involvement in any other research study\n* Systolic BP \\>190 or \\<100\n* Malignant arrhythmias\n* Renal or hepatic failure\n* Haemodynamically significant aortic stenosis\n* Severe or significant co-morbidity\n* Pacemakers\n\nHealthy volunteers\n\n* Any regular medication\n* Previous history of any cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT01179061', 'acronym': 'INO-apelin', 'briefTitle': 'Investigating the Inotropic Potential of Apelin', 'organization': {'class': 'OTHER', 'fullName': 'University of Edinburgh'}, 'officialTitle': 'Investigating the Inotropic Potential of Apelin in Healthy Volunteers and Patients With Chronic Stable Heart Failure', 'orgStudyIdInfo': {'id': '10/S1101/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apelin infusion', 'description': '6 hour infusion of apelin peptide into circulation', 'interventionNames': ['Drug: Apelin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Infusion of saline into systemic circulation', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Apelin', 'type': 'DRUG', 'description': 'Cardiac index will be assess in patients through the 6hr infusion, using thoracic cardiac bioimpedance. Prior to starting the infusion there will be a 30 minute run in period to achieve a stable cardiac index. Thereafter the infusion will be started, with cardiac index assess every five minutes during the first hour. For each subsequent hour participants will be free to mobilise for the thirty minute periods, with cardiac index and systemic haemodynmics assess for the following thirty minutes.\n\nAdditionally during the first hour pulmonary artery pressure will be estimated from pulmonary artery pressures assessed with echocardiography. This will be assessed at baseline with four further measurements during the first hour of infusion.\n\nParticipants will be asked to void prior to the study starting, thereafter all urine will be collected during the course of the study. Relevant biochemical/humoral factors will be assessed in the urine.', 'armGroupLabels': ['Apelin infusion']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'As per apelin arm, however we will use a saline placebo infusion. All other aspects will remain the same.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Clincial Research Facility, Royal Infirmary of Edinburgh, 51 Little France Cresc', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Gareth Barnes', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'EH16 4SA', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'University of Edinburgh', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Edinburgh', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr Gareth Barnes', 'oldOrganization': 'University of Edinburgh'}}}}