Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-05 @ 6:02 PM
Study NCT ID:
NCT03403868
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2018-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Right Ventricular Haemodynamic Evaluation and Response to Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018497', 'term': 'Ventricular Dysfunction, Right'}], 'ancestors': [{'id': 'D018754', 'term': 'Ventricular Dysfunction'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-17', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparibility of Ees (endsystolic elastance, which describes the right ventricular contractility) derived from conductance catheter, cMRI (cardiac magnetic resonance tomography) and 4D echocardiography', 'timeFrame': '12 weeks', 'description': 'right ventricular contractility can be obtained via different methods, our aim is to compare the different methods.\n\nEes is the endsystolic elastance which describes the contractility of the right ventricle'}], 'secondaryOutcomes': [{'measure': 'dp/dt max and min from Pressure-Wire vs. Conductance Katheter', 'timeFrame': '12 weeks', 'description': 'delta pressure/delta time is an indirect parameter of right ventricular contractility, which is load dependent'}, {'measure': 'Comparibility of volumetry assessed via magnetic resonance tomography (MRI) and 4D echocardiography (ECHO)', 'timeFrame': '12 weeks', 'description': 'Volumes (end-diastolic and endystolic) are measured via MRI and ECHO and compared with each other'}, {'measure': 'Comparibility of pressures measured via pressure wire and conductance catheter', 'timeFrame': '12 weeks', 'description': 'pressurewire measurements (high fidelity catheter) and conductance catheter (pressure volume catheter) are compared with each other'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Right Ventricular Dysfunction']}, 'referencesModule': {'references': [{'pmid': '34972609', 'type': 'DERIVED', 'citation': 'Kremer N, Rako Z, Douschan P, Gall H, Ghofrani HA, Grimminger F, Guth S, Naeije R, Rieth A, Schulz R, Seeger W, Tedford RJ, Vadasz I, Vanderpool R, Wiedenroth CB, Richter MJ, Tello K. Unmasking right ventricular-arterial uncoupling during fluid challenge in pulmonary hypertension. J Heart Lung Transplant. 2022 Mar;41(3):345-355. doi: 10.1016/j.healun.2021.11.019. Epub 2021 Dec 5.'}, {'pmid': '31500448', 'type': 'DERIVED', 'citation': 'Tello K, Wan J, Dalmer A, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Mohajerani E, Seeger W, Herberg U, Sommer N, Gall H, Richter MJ. Validation of the Tricuspid Annular Plane Systolic Excursion/Systolic Pulmonary Artery Pressure Ratio for the Assessment of Right Ventricular-Arterial Coupling in Severe Pulmonary Hypertension. Circ Cardiovasc Imaging. 2019 Sep;12(9):e009047. doi: 10.1161/CIRCIMAGING.119.009047. Epub 2019 Sep 10.'}, {'pmid': '30878422', 'type': 'DERIVED', 'citation': 'Tello K, Dalmer A, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Seeger W, Wilhelm J, Gall H, Richter MJ. Cardiac Magnetic Resonance Imaging-Based Right Ventricular Strain Analysis for Assessment of Coupling and Diastolic Function in Pulmonary Hypertension. JACC Cardiovasc Imaging. 2019 Nov;12(11 Pt 1):2155-2164. doi: 10.1016/j.jcmg.2018.12.032. Epub 2019 Mar 13.'}, {'pmid': '30616360', 'type': 'DERIVED', 'citation': 'Tello K, Dalmer A, Axmann J, Vanderpool R, Ghofrani HA, Naeije R, Roller F, Seeger W, Sommer N, Wilhelm J, Gall H, Richter MJ. Reserve of Right Ventricular-Arterial Coupling in the Setting of Chronic Overload. Circ Heart Fail. 2019 Jan;12(1):e005512. doi: 10.1161/CIRCHEARTFAILURE.118.005512.'}]}, 'descriptionModule': {'briefSummary': 'Mono-center Study to evaluate different multimodal functional parameter of the right ventricle in PAH-patients', 'detailedDescription': 'Mono-center-study tu evaluate functional parameters in cardiac MRI, conductance catheter (pressure-volume-loops), echocardiography and right heart catheter in PAH patients and to compare different multimodal parameters'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PH Nizza group 1 and patients without pulmonary hypertension after having the right heart catheter on clinical grounds\n* ability to sign informed consent\n* male and female between 18 to 85 years\n* haemodynamic criteria:\n\n * Pulmonary vascular resistance (PVR) \\> 240 dyn x sec x cm-5\n * Mean Pulmonary artery pressure (mPAP) ≥ 25 mmHg for PAH patients\n* normal haemodynamic in controls\n* therapy-naive or at least since two months stabil therapy with approved drugs for PAH (Sildenafil, Tadalafil, Macitentan, Ambrisentan, Bosentan, Iloprost, Treprostinil, Riociguat).\n\nExclusion Criteria:\n\n* therapy with positive inotropic drugs (dobutamin etc.)\n* missing informed consent\n* pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT03403868', 'acronym': 'Rightheart I', 'briefTitle': 'Right Ventricular Haemodynamic Evaluation and Response to Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'Right Ventricular Haemodynamic Evaluation and Response to Treatment', 'orgStudyIdInfo': {'id': '108/15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Conductance catheter', 'description': 'Contractility-measurement with conductance catheter (pressure-volume-catheter)', 'interventionNames': ['Diagnostic Test: conductance catheter']}], 'interventions': [{'name': 'conductance catheter', 'type': 'DIAGNOSTIC_TEST', 'description': 'pressure volume loops are assessed via a special catheter (Conductance catheter)', 'armGroupLabels': ['Conductance catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35392', 'city': 'Giessen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Khodr Tello, MD', 'role': 'CONTACT', 'email': 'khodr.tello@innere.med.uni-giessen.de', 'phone': '004964198556087'}, {'name': 'Manuel Richter, MD', 'role': 'CONTACT', 'email': 'manuel.richter@innere.med.uni-giessen.de', 'phone': '004964198556022'}], 'facility': 'University hospital Giessen', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}], 'centralContacts': [{'name': 'Khodr Tello, MD', 'role': 'CONTACT', 'email': 'khodr.tello@innere.med.uni-giessen.de', 'phone': '004964198556087'}, {'name': 'Manuel Richter, MD', 'role': 'CONTACT', 'email': 'manuel.richter@innere.med.uni-giessen.de', 'phone': '004964198556022'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Jan Grimminger', 'investigatorAffiliation': 'University of Giessen'}}}}