Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-01-02 @ 10:47 AM
Study NCT ID:
NCT07052968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Invasive and Non-invasive Haemodynamic Assessment of Pulmonary Hypertension in Chronic Kidney Disease Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-05-17', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of pulmonary hypertention in chronic kidney diseaes patients and identify its type and guide management.', 'timeFrame': 'One year', 'description': 'Hemodynamic assessment by echo including (right atrial surface area, right ventricular diameters, tricuspid annular plane systolic excursion ,tricusped regureg Jet velocity, inferior vena cava diameter and inspiratory collapability, estimated pulmonary artery pressure and left ventricular structure and function) and Hemodynamic assessment by RHC to diagnose and identify tyoe of PH according theses parameters a mean pulmonary arterial pressure (mPAP) \\>20 mm Hg, pulmonary artery wedge pressure (PAWP) ≤15mmHg and a PVR \\> 2WU. Pre-capillary PH ,mPAP \\>20 mmHg,PAWP ≤15mmHg,PVR ≥3WU.Isolated post-capillary PH (IpcPH),mPAP \\>20 mmHg,PAWP \\>15mmHg,PVR \\<3WU. Combined pre- and post-capillary PH (CpcPH),mPAP \\>20 mmHg,PAWP \\>15mmHg,PVR ≥3WU.Descriptive statistics will be done in the form of frequencies, mean and SD then analytic statistics will be done as chi square, independent sample test, correlations and regression tests, paired t-test will be'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '28770656', 'type': 'BACKGROUND', 'citation': 'Jankowich M, Hebel R, Jantz J, Abbasi S, Choudhary G. Multispecialty pulmonary hypertension clinic in the VA. Pulm Circ. 2017 Oct-Dec;7(4):758-767. doi: 10.1177/2045893217726063. Epub 2017 Aug 22.'}, {'pmid': '25610603', 'type': 'BACKGROUND', 'citation': 'Pugh ME, Hemnes AR, Trammell A, Newman JH, Robbins IM. Variability in hemodynamic evaluation of pulmonary hypertension at large referral centers. Pulm Circ. 2014 Dec;4(4):679-84. doi: 10.1086/678514.'}]}, 'descriptionModule': {'briefSummary': 'Patients with CKD who suspected to have pulmonary hypertension by echocardiography with high probability, RHC used to confirm the diagnosis, assessment of hemodynamic parameters, differentiate pre and post capillary types of pulmonary hypertension and asses severity of the disease.', 'detailedDescription': 'Pulmonary Hypertension (PH ) is a haemodynamic and pathophysiological condition characterized by an increase in mean pulmonary arterial pressure ≥ 20 mmHg at rest, measured by right heart catheterization \\[1\\]. It results from various etiologies and multifactorial mechanisms. PH is associated with increased morbidity and mortality in patients with chronic kidney disease (CKD) .\n\nCKD is defined as abnormalities in kidney structure or function persisting for more than three months, with implications for health. The latest KDIGO guidelines classify CKD based on glomerular filtration rate and albuminuria categories \\[2\\]. CKD has systemic complications a cardiovascular and pulmonary vascular disorders.\n\nThe PH in CKD patients is multifactorial, involving volume overload, endothelial dysfunction, vascular calcification, and increased left sided pressures \\[3\\].\n\nEchocardiography is the primary non-invasive tool for assessing PH . It estimates systolic pulmonary artery pressure and evaluates right ventricular structure and function . Although widely accessible, ECHO has limitations ;operator dependency and potential underestimation or overestimation of pressures \\[4\\]. ESC/ERS guidelines for pulmonary hypertension in assessing the probablity (6) as :\n\nHigh probability: TRV \\>3.4 m/s or TRV 2.9-3.4 m/s with other echo PH signs Intermediate probability: TRV 2.9-3.4 m/s without other echo PH signs Low probability: TRV ≤2.8 m/s and no other PH signs. Right heart catheterization (RHC) remains the gold standard for definitive PH diagnosis. It provides direct hemodynamic measurements, distinguishing pre-capillary from post-capillary PH. RHC is crucial for guiding targeted therapy and risk stratification, ensuring accurate management in CKD patients with suspected PH (5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Admitted patients in Internal medicine department, Critical care unit and pulmonary hypertension unit chest department at Assuit University Hospital.', 'genderDescription': 'All genders', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All adult (aged 18 years old and older) patients who were diagnosed CKD(The presence of kidney damage or an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m², persisting for 3 months or more) and suspected to have pulmonary hypertension by clinical feature or by echocardiography with high probability were included in this study.\n\nExclusion Criteria:\n\n* • Patients under 18 years old\n\n * Patient with chronic chest disease.\n * Patient bleeding diathesis and high risk of bleeding.\n * Individuals having acute kidney injury.\n * Patient developing other PH aetiologies.'}, 'identificationModule': {'nctId': 'NCT07052968', 'briefTitle': 'Invasive and Non-invasive Haemodynamic Assessment of Pulmonary Hypertension in Chronic Kidney Disease Patient', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Invasive and Non-invasive Haemodynamic Assessment of Pulmonary Hypertension in Chronic Kidney Disease Patient', 'orgStudyIdInfo': {'id': 'RHC in PH pts e ckd'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Echocardiography', 'type': 'DEVICE', 'description': 'Echocardiography is the non invasvive interventional assessment and the RHC is the invasive international assessment of the hemodynamics in PH patients with ckd.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Randa Ahmed, MD', 'role': 'CONTACT', 'email': 'randasarhan@aun.edu.eg', 'phone': '+201118683728'}, {'name': 'Alaa Omar, Phd', 'role': 'CONTACT', 'email': 'alaa_omar11@yahoo.com', 'phone': '+20102 365 8355'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr,', 'investigatorFullName': 'Randa Ahmed Sarhan', 'investigatorAffiliation': 'Assiut University'}}}}