Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-30 @ 1:13 PM
Study NCT ID:
NCT04764032
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2021-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Right Ventricular Dysfunction in Ventilated Patients With COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of RV dysfunction in ventilated patients with COVID-19', 'timeFrame': 'Any timepoint from eligibility (ventilation for more than 48 hours) to 14 days following tracheal intubation and positive pressure ventilation.', 'description': 'RV dysfunction will be defined as Trans Thoracic Echo (TTE) evidence of RV dilatation along with the presence of septal flattening (in systole, diastole or both).'}, {'measure': 'Association of RV dysfunction with 30-day mortality.', 'timeFrame': 'Up to 30-days following intubation and intermittent positive pressure ventilation'}], 'secondaryOutcomes': [{'measure': 'Association of ARDS and RV dysfunction', 'timeFrame': 'At time of echocardiography'}, {'measure': 'Association of micro/macro thrombi and RV dysfunction', 'timeFrame': 'At time of echocardiography'}, {'measure': 'The association of direct myocardial injury and RV dysfunction', 'timeFrame': 'At time of echocardiography'}, {'measure': 'The association of ventilation and RV dysfunction', 'timeFrame': 'At time of echocardiography'}, {'measure': 'Association of ARDS and 30-day mortality', 'timeFrame': 'Up to 30-days following intubation and intermittent positive pressure ventilation'}, {'measure': 'Association of micro/macro thrombi and 30-day mortality', 'timeFrame': 'Up to 30-days following intubation and intermittent positive pressure ventilation'}, {'measure': 'Association of direct myocardial injury and 30-day mortality', 'timeFrame': 'Up to 30-days following intubation and intermittent positive pressure ventilation'}, {'measure': 'Association of ventilation and 30-day mortality', 'timeFrame': 'Up to 30-days following intubation and intermittent positive pressure ventilation'}, {'measure': 'The difference in NP levels between patients with, and patients without, RV dysfunction.', 'timeFrame': 'At time of echocardiography'}, {'measure': 'The difference in hsTn between patients with, and patients without, RV dysfunction.', 'timeFrame': 'At time of echocardiography'}, {'measure': 'Association between hsTn and 30-day mortality in patients with, and patients without, RV dysfunction', 'timeFrame': 'Up to 30-days following intubation and intermittent positive pressure ventilation'}, {'measure': 'Association between NP levels and 30-day mortality in patients with, and patients without, RV dysfunction', 'timeFrame': 'Up to 30-days following intubation and intermittent positive pressure ventilation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Right Ventricle', 'Echocardiography', 'ARDS'], 'conditions': ['Covid19', 'Right Ventricular Dysfunction', 'ARDS']}, 'referencesModule': {'references': [{'pmid': '33441361', 'type': 'BACKGROUND', 'citation': 'Willder JM, McCall P, Messow CM, Gillies M, Berry C, Shelley B. Study protocol for COVID-RV: a multicentre prospective observational cohort study of right ventricular dysfunction in ventilated patients with COVID-19. BMJ Open. 2021 Jan 13;11(1):e042098. doi: 10.1136/bmjopen-2020-042098.'}, {'pmid': '36370220', 'type': 'DERIVED', 'citation': 'McErlane J, McCall P, Willder J, Berry C, Shelley B; COVID-RV investigators. Right ventricular free wall longitudinal strain is independently associated with mortality in mechanically ventilated patients with COVID-19. Ann Intensive Care. 2022 Nov 12;12(1):104. doi: 10.1186/s13613-022-01077-7.'}]}, 'descriptionModule': {'briefSummary': 'Using echocardiography to investigate the incidence of RV dysfunction in ventilated patients with COVID-19.', 'detailedDescription': "INTRODUCTION Following the first reported cases in China, there has been a worldwide pandemic of a new virus commonly known as, Coronavirus. The virus causes a number of conditions including; cough, high temperature, painful muscles and breathing difficulties. The disease the virus causes is known as Coronavirus Disease 2019 (COVID-19). In the majority of cases these symptoms will get better without any treatment and without needing admission to hospital. In a small proportion of cases, the symptoms can be so bad that patients will need admission to hospital. Of the group admitted to hospital an even smaller group (approximately 5% of all confirmed coronavirus cases) will need treatment in an intensive care unit. This is often for severe breathing difficulties and sometimes requires the patient to be put on a breathing machine. The breathing machine is also known as a life support machine or ventilator and needing its support is known as 'ventilation' or 'being ventilated'.\n\nIn other conditions causing severe breathing difficulties requiring ventilation, pressure can be put on the right side of the heart ('the right heart \\[or right ventricle\\];' the part of the heart pumping blood to the lungs). This can cause the right heart to fail, struggling to pump blood forward and with a build-up of back pressure. This is also known as right heart (or ventricular) dysfunction. Patients needing ventilated, who develop problems with the right heart, are less likely to survive their intensive care stay. No scientists have examined whether patients with COVID-19, requiring ventilation, have problems with their right heart.\n\nMETHODS Using noninvasive ultrasound scans of the heart (echocardiography) the investigators will explore whether ventilated patients in intensive care have problems with their right heart. The investigators will also collect blood samples to look for damage to the heart during this time.\n\nAIMS The aim of this study is to determine how many patients with COVID-19 needing ventilation have problems with the right heart. The investigators will explore if those patients with right heart problems are more likely to die by 30 days following their intensive care admission. By examining clinical data, the investigators will also look to see if any other conditions or treatments increase the risk of right heart problems. By identifying right heart problems in these patients, the investigators may be able to guide future studies to determine if any specific treatments targeted at protecting the right heart can improve outcomes in this patient group."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients requiring tracheal intubation and intermittent positive pressure ventilation for COVID-19 in Scottish intensive care units', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent.\n* Age \\> 16 years.\n* Confirmed SARS-CoV-2 infection with severe acute respiratory failure requiring tracheal intubation and positive pressure ventilation in intensive care for more than 48 hours.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Ongoing participation in any investigational research that may undermine the scientific basis of the study.\n* Prior participation in the COVID-RV study.\n* Ventilated for less than 48 hours prior to study recruitment.\n* Those patients requiring extra-corporeal life support for respiratory or cardiovascular failure (veno-venous \\[VV\\] or veno-arterial \\[VA\\] extra-corporeal membrane oxygenation \\[ECMO\\]).\n* Patient where end of life care has been instituted and they are not expected to survive for the next 24 hours.'}, 'identificationModule': {'nctId': 'NCT04764032', 'acronym': 'COVID-RV', 'briefTitle': 'Right Ventricular Dysfunction in Ventilated Patients With COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'Right Ventricular Dysfunction in Ventilated Patients With COVID-19', 'orgStudyIdInfo': {'id': '20/COVID/17'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Echocardiography will be undertaken by a range of appropriately competent practitioners including; intensive care clinicians, cardiologists and specialist echocardiographers. Imaging obtained will be in keeping with the protocol required for a Focused Intensive Care Echo (FICE) scan and should include ECG monitoring at all times. A focused dataset will be used to answer the primary outcome. If available and the echocardiographers competency and experience permit, further measures of RV function will be obtained at this time.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'James MacBrayne', 'role': 'CONTACT'}, {'name': 'James MacBrayne', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'KA6 6DX', 'city': 'Ayr', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Derek McLaughlan', 'role': 'CONTACT'}, {'name': 'Derek McLaughlan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Univeristy Hospital, Ayr', 'geoPoint': {'lat': 55.46273, 'lon': -4.63393}}, {'city': 'Clydebank', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ben Shelley, MD', 'role': 'CONTACT', 'email': 'b.shelley@clinmed.gla.ac.uk', 'phone': '0141 9515000', 'phoneExt': '4293'}, {'name': 'Ben Shelley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Philip McCall, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Golden Jubilee National Hospital', 'geoPoint': {'lat': 55.90137, 'lon': -4.4057}}, {'zip': 'DG2 8RX', 'city': 'Dumfries', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Alexander McDonald', 'role': 'CONTACT'}, {'name': 'Alexander McDonald', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dumfries and Galloway Royal Infirmary', 'geoPoint': {'lat': 55.06959, 'lon': -3.61139}}, {'zip': 'G75 8RG', 'city': 'East Kilbride', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nina Tatarkowska, MBChB', 'role': 'CONTACT'}, {'name': 'Nina Tatarkowska, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Hairmyres', 'geoPoint': {'lat': 55.76412, 'lon': -4.17669}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Malcolm Sim, MD', 'role': 'CONTACT'}, {'name': 'Malcolm Sim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Elizabeth University Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Glasgow', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Alex Puxty, MBChB', 'role': 'CONTACT'}, {'name': 'Alex Puxty, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Glasgow Royal Infirmary', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'IV2 3JH', 'city': 'Inverness', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Benjamin Greatorex', 'role': 'CONTACT'}, {'name': 'Benjamin Greatorex', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Raigmore Hospital', 'geoPoint': {'lat': 57.47908, 'lon': -4.22398}}, {'zip': 'KA2 0BE', 'city': 'Kilmarnock', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'John Allan', 'role': 'CONTACT'}, {'name': 'John Allan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital, Crosshouse', 'geoPoint': {'lat': 55.61171, 'lon': -4.49581}}, {'zip': 'PA2 9PJ', 'city': 'Paisley', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Lisa Gemmell, MBChB', 'role': 'CONTACT'}, {'name': 'Lisa Gemmell, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Royal Alexandra hospital', 'geoPoint': {'lat': 55.83173, 'lon': -4.43254}}, {'zip': 'ML2 0DP', 'city': 'Wishaw', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dominic Strachan, MBChB', 'role': 'CONTACT'}, {'name': 'Dominic Strachan, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital, Wishaw', 'geoPoint': {'lat': 55.76667, 'lon': -3.91667}}], 'centralContacts': [{'name': 'Ben Shelley, MD', 'role': 'CONTACT', 'email': 'benjamin.shelley@glasgow.ac.uk', 'phone': '01419515000', 'phoneExt': '4293'}, {'name': 'Philip McCall, MD', 'role': 'CONTACT', 'email': 'philipmccall@nhs.net', 'phone': '01419515000', 'phoneExt': '4293'}], 'overallOfficials': [{'name': 'Ben Shelley, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Glasgow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'collaborators': [{'name': 'Golden Jubilee National Hospital', 'class': 'OTHER_GOV'}, {'name': 'Robertson Centre for Biostatistics', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Clinical Associate Professor', 'investigatorFullName': 'Dr Ben Shelley', 'investigatorAffiliation': 'University of Glasgow'}}}}