Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-03-06 @ 5:55 AM
Study NCT ID:
NCT03749551
Status:
COMPLETED
Last Update Posted:
2023-07-13
First Post:
2018-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Towards Understanding the Phenotype of Cardiovascular Disease in CKD - TRUE-Type-CKD Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D017379', 'term': 'Hypertrophy, Left Ventricular'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart 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'}, {'id': 'D006332', 'term': 'Cardiomegaly'}, {'id': 'D006984', 'term': 'Hypertrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2018-11-17', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in native T1 and T2 (in msec) pre and post haemodialysis', 'timeFrame': '24 hour', 'description': 'measurement of change in magnetisation relaxation (in msec)'}], 'primaryOutcomes': [{'measure': 'survival', 'timeFrame': '1 year', 'description': 'number of deaths'}, {'measure': 'survival', 'timeFrame': '5 year', 'description': 'number of deaths'}, {'measure': 'rate of death due to cardiovascular causes', 'timeFrame': '1 year', 'description': 'number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure'}, {'measure': 'rate of death due to cardiovascular causes', 'timeFrame': '5 year', 'description': 'number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure'}], 'secondaryOutcomes': [{'measure': 'rate of heart failure events', 'timeFrame': '1 year', 'description': 'number of participants with heart failure death and hospitalisation due to heart failure'}, {'measure': 'rate of heart failure events', 'timeFrame': '5 year', 'description': 'number of participants with heart failure death and hospitalisation due to heart failure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Cardiomyopathies', 'Chronic Kidney Diseases', 'Hypertrophy, Left Ventricular']}, 'referencesModule': {'references': [{'pmid': '34092229', 'type': 'RESULT', 'citation': 'Arcari L, Engel J, Freiwald T, Zhou H, Zainal H, Gawor M, Buettner S, Geiger H, Hauser I, Nagel E, Puntmann VO. Cardiac biomarkers in chronic kidney disease are independently associated with myocardial edema and diffuse fibrosis by cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2021 Jun 7;23(1):71. doi: 10.1186/s12968-021-00762-z.'}, {'pmid': '37238643', 'type': 'RESULT', 'citation': 'Valbuena-Lopez SC, Camastra G, Cacciotti L, Nagel E, Puntmann VO, Arcari L. Cardiac Imaging Biomarkers in Chronic Kidney Disease. Biomolecules. 2023 Apr 29;13(5):773. doi: 10.3390/biom13050773.'}, {'pmid': '31304234', 'type': 'RESULT', 'citation': 'Chen M, Arcari L, Engel J, Freiwald T, Platschek S, Zhou H, Zainal H, Buettner S, Zeiher AM, Geiger H, Hauser I, Nagel E, Puntmann VO. Aortic stiffness is independently associated with interstitial myocardial fibrosis by native T1 and accelerated in the presence of chronic kidney disease. Int J Cardiol Heart Vasc. 2019 Jun 26;24:100389. doi: 10.1016/j.ijcha.2019.100389. eCollection 2019 Sep.'}, {'pmid': '32169347', 'type': 'RESULT', 'citation': 'Arcari L, Hinojar R, Engel J, Freiwald T, Platschek S, Zainal H, Zhou H, Vasquez M, Keller T, Rolf A, Geiger H, Hauser I, Vogl TJ, Zeiher AM, Volpe M, Nagel E, Puntmann VO. Native T1 and T2 provide distinctive signatures in hypertrophic cardiac conditions - Comparison of uremic, hypertensive and hypertrophic cardiomyopathy. Int J Cardiol. 2020 May 1;306:102-108. doi: 10.1016/j.ijcard.2020.03.002. Epub 2020 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'Premature cardiovascular disease (CVD) is the leading cause of death in patients with kidney disease (CKD). Excessive cardiac mortality is thought to be secondary to non-atherosclerotic processes, with left ventricular (LV) hypertrophy (LVH) and remodelling being the predominant phenotypical features. Along with other risk factors, subclinical ischaemia and haemodynamic perturbations associated with haemodialysis (HD) are thought to contribute to the ultimate development of LV systolic and diastolic dysfunction. The development of these adverse features reflects a specific cardiomyopathy due to CKD and subsequently, to uraemia. Patients receiving hemodialysis (HD) have a higher incidence rate of heart failure (predominantly with preserved ejection fraction), with phenotypically eccentric hypertrophic remodelling, systolic and diastolic dysfunction as well as high rate of interstitial myocardial fibrosis. Detection and ultimately reversal of the development of this CKD-related cardiomyopathy are important goals for improving the CVD, morbidity and mortality of CKD patients.The objectives of this study are, firstly, to investigate the complex myocardial phenotype in patients with various stages of CKD, secondly, to relate the CMR-measures to outcome, and thirdly, to be able to estimate the effects of chronic uremia/hypervolemia. Deciphering the predominant driver of remodelling on an individual level may help to personalise anti-remodelling strategies. Native T1 and T2 mapping imaging provide non-invasive imaging tools to detect myocardial fibrosis and oedema, respectively. Prognostic associations of these measures may clarify the relative prevalence of adverse phenotype and their relative contribution to adverse events and poor outcome. The role of chronic water retention and uraemia may be associated with interstitial myocardial oedema promoting further the remodelling process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with established diagnosis of chronic kidney disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults \\>18 years of age\n2. Able to provide informed consent\n3. Chronic kidney disease stages G3-5 (eGFR\\<59 ml/min/1.73m2)\n\nExclusion Criteria:\n\n1. Absence of absolute clinical indication for MRI studies (MR unsafe or incompatible devices, aneurysm clips, cochlear implants, loose metal foreign objects)\n2. Absolute contraindications to gadolinium contrast agent (previous allergic reaction or pregnancy),'}, 'identificationModule': {'nctId': 'NCT03749551', 'acronym': 'TRUE-TypeCKD', 'briefTitle': 'Towards Understanding the Phenotype of Cardiovascular Disease in CKD - TRUE-Type-CKD Study', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'TowaRds Understanding the phEnoTYPEs of Cardiovascular Dysfunction in Patients With Chronic Kidney Disease and HaemoDialysis Using Cardiovascular Magnetic Resonance Imaging - TRUE-Type-CKD Study', 'orgStudyIdInfo': {'id': 'TrueTypeCKD 4/17'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'diagnostic test - patients serving as their own controls', 'interventionNames': ['Diagnostic Test: cardiac magnetic resonance (CMR) post haemodialysis']}], 'interventions': [{'name': 'cardiac magnetic resonance (CMR) post haemodialysis', 'type': 'DIAGNOSTIC_TEST', 'description': 'patients will undergo a second CMR scan immediately after receiving haemodialysis (native CMR study)', 'armGroupLabels': ['Participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'Frankfurt am Main', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kerckhoff Klinik', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical professor', 'investigatorFullName': 'Valentina Puentmann', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}