Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT03706820
Status:
UNKNOWN
Last Update Posted:
2018-10-16
First Post:
2018-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Hemodynamics in Patients With Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-11', 'studyFirstSubmitDate': '2018-09-29', 'studyFirstSubmitQcDate': '2018-10-11', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total pulmonary resistance (TPR) from rest to exercise', 'timeFrame': '2nd minute,4th minute, 6th minute, 8th minute', 'description': 'The patient undergoes right heart catheterization and all hemodynamic variables are measured at rest and at exercise. TPR is derived by the following equation : mean pulmonary artery pressure/ cardiac output (mPAP/CO). TPR is measured at rest and at exercise following a specific protocol. The measurements are made at rest, then at the sequential exercise steps of increasing work resistance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '29167297', 'type': 'RESULT', 'citation': 'Kovacs G, Herve P, Barbera JA, Chaouat A, Chemla D, Condliffe R, Garcia G, Grunig E, Howard L, Humbert M, Lau E, Laveneziana P, Lewis GD, Naeije R, Peacock A, Rosenkranz S, Saggar R, Ulrich S, Vizza D, Vonk Noordegraaf A, Olschewski H. An official European Respiratory Society statement: pulmonary haemodynamics during exercise. Eur Respir J. 2017 Nov 22;50(5):1700578. doi: 10.1183/13993003.00578-2017. Print 2017 Nov.'}, {'pmid': '26022955', 'type': 'RESULT', 'citation': 'Herve P, Lau EM, Sitbon O, Savale L, Montani D, Godinas L, Lador F, Jais X, Parent F, Gunther S, Humbert M, Simonneau G, Chemla D. Criteria for diagnosis of exercise pulmonary hypertension. Eur Respir J. 2015 Sep;46(3):728-37. doi: 10.1183/09031936.00021915. Epub 2015 May 28.'}, {'pmid': '35568651', 'type': 'DERIVED', 'citation': 'Panagiotidou E, Betaoutou A, Fouka E, Papakosta D, Chatzopoulos E, Sourla E, Markopoulou A, Kioumis I, Stanopoulos I, Pitsiou G. Phenotyping exercise limitation of patients with Interstitial Fibrosing Lung Disease: the importance of exercise hemodynamics. Pulmonology. 2024 Mar-Apr;30(2):104-112. doi: 10.1016/j.pulmoe.2022.03.012. Epub 2022 May 11.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the rest and exercise hemodynamics of patients presenting either idiopathic fibrotic pulmonary disease or pulmonary fibrosis secondary to connective tissue disease.', 'detailedDescription': 'Patients with fibrotic pulmonary disease of the above origin will undergo detailed assessment of functional status with the following examinations: pulmonary function tests, echocardiogram, 6 minute exercise test, cardiopulmonary exercise test (in the absence of contra-indications) and finally right heart catheterization. Hemodynamic assessment will take place at rest and at exercise following the exercise protocol that was recommended by Herve et al (ERJ 2015) using a cycle ergometer at bedside.\n\nThe purposes of the study are:\n\n1. to evaluate the response of the hemodynamic parameters at exercise compared to the resting parameters in this patient group.\n2. to discriminate between precapillary from postcapillary etiology of pulmonary hypertension.\n3. to correlate non-invasive parameters of functional limitation with invasive hemodynamic parameters.\n4. to assess the prognostic role of exercise induced pulmonary hypertension in the specific patient group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients are currently followed up in the Respiratory Clinics of the investigator's hospital and will be enrolled if suitable after having signed the form of consent.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diagnosis of pulmonary fibrosis secondary to connective tissue disease, according to the American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) revised classification criteria , or diagnosis of idiopathic fibrotic diffuse pulmonary disease according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines\n2. Forced vital capacity (FVC) ≥ 40 %\n\nExclusion Criteria:\n\n1. Presence of contra-indications to exercise tests, such as acute myocardial infarction, unstable angina, uncontrollable arrythmia or skeletal disease that limits the ability to exercise.\n2. History of pulmonary embolism during the year before enrollment\n3. Presence of severe valvular disease.\n4. Current treatment with vasoactive drugs of the pulmonary circulation\n5. Pulmonary wedge pressure (PAWP) at rest \\> 15 mmHg'}, 'identificationModule': {'nctId': 'NCT03706820', 'briefTitle': 'Exercise Hemodynamics in Patients With Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Hemodynamic Study of the Pulmonary Circulation in Exercise in Patients With Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': 'MED-AUTH-3.1/02-05-2018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'normal rest and exercise hemodynamics'}, {'label': 'normal rest and abnormal exercise hemodynamics'}, {'label': 'resting pulmonary hypertension'}, {'label': 'abnormal wedge pressure at exercise'}]}, 'contactsLocationsModule': {'locations': [{'zip': '57010', 'city': 'Thessaloniki', 'state': 'Asvestochori', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Evangelia S Panagiotidou, MD', 'role': 'CONTACT', 'email': 'evangeliapanagiotidou@gmail.com', 'phone': '+306949139509'}], 'facility': 'G.H. G. Papanikolaou', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Evangelia S Panagiotidou, MD', 'role': 'CONTACT', 'email': 'evangeliapanagiotidou@gmail.com', 'phone': '+306949139509'}, {'name': 'Georgia G Pitsiou, MD, PhD', 'role': 'CONTACT', 'email': 'gpitsiou@yahoo.gr'}], 'overallOfficials': [{'name': 'Georgia G Pitsiou, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aristotle University Of Thessaloniki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd candidate, Resident of Pulmonary medicine, G.H.G.Papanikolaou, Thessaloniki, Greece', 'investigatorFullName': 'EVAGGELIA PANAGIOTIDOU', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}