Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
Study NCT ID:
NCT04524468
Status:
COMPLETED
Last Update Posted:
2020-08-26
First Post:
2020-08-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Right Ventricular Function in End-stage Renal Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-22', 'studyFirstSubmitDate': '2020-08-20', 'studyFirstSubmitQcDate': '2020-08-20', 'lastUpdatePostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of right ventricular function in end-stage renal disease patients', 'timeFrame': '1 week', 'description': 'Transthoracic echocardiography was performed to end-stage renal disease patients on hemodialysis and peritoneal dialysis for at least 6 months. Tricuspid annular plane systolic excursion (TAPSE), right ventricular fractional area change (RV FAC), Right ventricular myocardial performance index (RV MPI) and right ventricular lateral peak annular systolic velocity (Sa) were measured to estimate right ventricular function.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['echocardiography', 'hemodialysis', 'peritoneal dialysis', 'right ventricle'], 'conditions': ['Transthoracic Echocardiography', 'Hemodialysis']}, 'descriptionModule': {'briefSummary': 'Right ventricular (RV) dysfunction is a major cause of heart failure and mortality in end-stage renal disease (ESRD) patients. The aim of the study was to evaluate the long-term impacts of different dialysis modalities on RV function assessed by conventional echocardiography in ESRD patients with preserved left ventricular function. The study included 83 ESRD patients grouped as follows: peritoneal dialysis (PD; n=46) and hemodialysis with brachial arterio-venous fistula (HD; n=37). Conventional echocardiography including 2D and tissue Doppler imaging was performed in all patients. Echocardiographic parameters were compared between groups.', 'detailedDescription': 'Cardiovascular diseases (CVD) are the main causes of death in patients undergoing dialysis. Right ventricular (RV) dysfunction is one of the major predictors of mortality and heart failure in this patient group. It has been shown that patients undergoing hemodialysis (HD) which is usually carried out via a surgically created arteriovenous fistula (AVF) have an increased risk for pulmonary hypertension and poorer right ventricular function compared with healthy controls . However, there are few data comparing the patients undergoing HD and peritoneal dialysis (PD), in terms of echocardiographic right ventricular function.\n\nThe aim of the present study was to elucidate the impact of both long term PD and HD therapy via brachial AVF on RV function in patients with preserved left ventricular (LV) function.\n\nPatients undergoing dialysis were grouped as follows: 46 patients on PD and 37 patients on HD with brachial AVF. All of the study patients underwent transthoracic echocardiography. Left and right ventricular parameters were compared between two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'End-stage renal disease patients on a regular dialysis program at least 6 months', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End-stage renal disease patients on a regular dialysis program\n* Being on dialysis at least 6 months\n* \\>18 years old\n\nExclusion Criteria:\n\n* Ischemic heart disease\n* Left ventricular systolic dysfunction with an ejection fraction (EF) of less than 55 %\n* Valvulopathy\n* Left bundle branch block\n* Atrial fibrilation\n* Previous renal transplantation\n* Chronic obstructive pulmonary disease\n* Interstitial lung diseases\n* Connective tissue disorders\n* Chronic thromboembolic disease\n* Congenital left-to-right shunt\n* Primary pulmonary hypertension'}, 'identificationModule': {'nctId': 'NCT04524468', 'briefTitle': 'Right Ventricular Function in End-stage Renal Disease Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Antalya Training and Research Hospital'}, 'officialTitle': 'The Impact of Different Dialysis Modalities on Right Ventricular Function in End-stage Renal Disease Patients', 'orgStudyIdInfo': {'id': '2019-398'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hemodialysis patients', 'description': 'end-stage renal disease patients on hemodialysis', 'interventionNames': ['Diagnostic Test: Transthoracic echocardiography']}, {'label': 'peritoneal dialysis patients', 'description': 'end-stage renal disease patients on peritoneal dialysis', 'interventionNames': ['Diagnostic Test: Transthoracic echocardiography']}], 'interventions': [{'name': 'Transthoracic echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Conventional 2-D transthoracic echocardiography was performed to all patients', 'armGroupLabels': ['hemodialysis patients', 'peritoneal dialysis patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Antalya Research and Training Hospital', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Duygu Ersan Demirci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Antalya Research and Training Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Antalya Training and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Duygu Ersan Demirci', 'investigatorAffiliation': 'Antalya Training and Research Hospital'}}}}