Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-24 @ 7:38 PM
Study NCT ID:
NCT03061669
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2017-02-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Monitoring During Right Heart
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-26', 'studyFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2017-02-19', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary artery pressure', 'timeFrame': 'only during the procedure of right heart catheterization', 'description': 'In mmHg measured by Swan-Ganz catheter'}, {'measure': 'Respiratory flow', 'timeFrame': 'only during the procedure of right heart catheterization', 'description': 'ml units'}, {'measure': 'Chest wall acceleration', 'timeFrame': 'only during the procedure of right heart catheterization', 'description': 'local tidal displacement'}], 'secondaryOutcomes': [{'measure': 'Right ventricle pressure', 'timeFrame': 'only during the procedure of right heart catheterization', 'description': 'In mmHg measured by Swan-Ganz catheter'}, {'measure': 'Pulmonary artery wedge pressure', 'timeFrame': 'only during the procedure of right heart catheterization', 'description': 'In mmHg measured by Swan-Ganz catheter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'pulmonary hypertension', 'right heart catheterization'], 'conditions': ['Pulmonary Hypertension', 'Heart Failure']}, 'descriptionModule': {'briefSummary': 'Respiratory monitoring during right heart catheterization to differentiate between various types of pulmonary hypertension; The effects of the cardiovascular system on the lung mechanical properties.', 'detailedDescription': 'Differentiation between different kinds of pulmonary hypertension (PHTN) requires right heart catheterization. Monitoring heart failure patients is challenging in many. The study will enroll patients undergoing right heart catheterization (RHC) for the evaluation of heart failure and PHTN, based on the regular clinical practice. The regular indices as the right ventricle pressure (RVP), pulmonary artery pressure (PAP), pulmonary artery wedge pressure (PAWP), and cardiac output will be measured with the Swan Ganz Catheter and recorded.\n\nNoninvasive measurement of the respiratory flow will be acquired by a medical approved flow-meter that is mounted on a simple plastic breathing mask.\n\nNon-invasive system that includes three accelerometers that are attached to the chest and epigastrium of the patient will be used to measure respiratory chest wall dynamics.\n\nThrough evaluating the correlation between the invasive and non-invasive measurements the study intends to prove the ability of the non-invasive system to provide the required information.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing right heart catheterization (RHC) for the evaluation of heart failure and pulmonary hypertension, based on the regular clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing right heart catheterization\n\nExclusion Criteria:\n\n* Inability or unwillingness to follow or to sign the study protocol.'}, 'identificationModule': {'nctId': 'NCT03061669', 'briefTitle': 'Respiratory Monitoring During Right Heart', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Respiratory Monitoring During Right Heart Catheterization to Differentiate Between Various Types of Pulmonary Hypertension; The Effects of the Cardiovascular System on the Lung Mechanical Properties', 'orgStudyIdInfo': {'id': '0370-16'}}, 'contactsLocationsModule': {'locations': [{'zip': '3109601', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yair Feld, MD', 'role': 'CONTACT', 'email': 'y_feld@rmc.gov.il', 'phone': '+972-4-7772181'}], 'facility': 'Rambam medical center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Yair Feld, MD', 'role': 'CONTACT', 'email': 'y_feld@rmc.gov.il', 'phone': '+972-47772181'}], 'overallOfficials': [{'name': 'Yair Feld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technion, Israel Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'yair feld MD', 'investigatorAffiliation': 'Rambam Health Care Campus'}}}}