[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100310579":3},{"organization":4,"outcomesModule":7,"designInfo":76,"detailedDescription":79,"studyPopulation":80,"armGroups":81,"interventions":97,"overallOfficials":112,"centralContacts":117,"locations":126,"responsibleParty":144,"collaborators":75,"id":147,"slug":75,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":148,"sex":154,"minAge":155,"maxAge":75,"enrollmentInfo":156,"targetDuration":75,"studyType":159,"phases":75,"briefSummary":160,"conditions":161,"keywords":75,"overallStatus":129,"whyStopped":75,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"RWTH Aachen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":75,"otherOutcomes":75},[9,13,15,18,19,22,23,26,27,30,31,34,35,38,39,42,43,46,47,50,51,54,55,58,59,62,63,66,67,70,71,74],{"measure":10,"description":11,"timeFrame":12},"Oxygen partial pressure (pO2) [mmHg]","Results of blood gas analysis:\n\nOxygen partial pressure (pO2) \\[mmHg\\]","Directly prior to the CRT-implantation",{"measure":10,"description":11,"timeFrame":14},"6 months after CRT-implantation",{"measure":16,"description":17,"timeFrame":12},"Carbon dioxide partial pressure (pCO2) [mmHg]","Results of blood gas analysis:\n\nCarbon dioxide partial pressure (pCO2) \\[mmHg\\]",{"measure":16,"description":17,"timeFrame":14},{"measure":20,"description":21,"timeFrame":12},"potential of hydrogen (pH) value [-]","Results of blood gas analysis:\n\npH value \\[-\\]",{"measure":20,"description":21,"timeFrame":14},{"measure":24,"description":25,"timeFrame":12},"Base excess [mmol]","Results of blood gas analysis:\n\nBase excess \\[mmol\\]",{"measure":24,"description":25,"timeFrame":14},{"measure":28,"description":29,"timeFrame":12},"Lactate [mmol\u002Fl]","Results of blood gas analysis:\n\nLactate \\[mmol\u002Fl\\]",{"measure":28,"description":29,"timeFrame":14},{"measure":32,"description":33,"timeFrame":12},"Glucose [mg\u002Fdl]","Results of blood gas analysis:\n\nGlucose \\[mg\u002Fdl\\]",{"measure":32,"description":33,"timeFrame":14},{"measure":36,"description":37,"timeFrame":12},"Electrolytes (K+, Na2+, Ca2+) [mmol\u002Fl]","Results of blood gas analysis:\n\nElectrolytes (K+, Na2+, Ca2+) \\[mmol\u002Fl\\]",{"measure":36,"description":37,"timeFrame":14},{"measure":40,"description":41,"timeFrame":12},"High-sensitive troponin T [µg\u002FL]","Markers of myocardial ischemia and heart failure:\n\nHigh-sensitive troponin T \\[µg\u002FL\\]",{"measure":40,"description":41,"timeFrame":14},{"measure":44,"description":45,"timeFrame":12},"Total creatine kinase [µg\u002FL]","Markers of myocardial ischemia and heart failure:\n\nTotal creatine kinase \\[µg\u002FL\\]",{"measure":44,"description":45,"timeFrame":14},{"measure":48,"description":49,"timeFrame":12},"Creatinine kinase-myocardial band (CK-MB) [µg\u002FL]","Markers of myocardial ischemia and heart failure:\n\nCreatinine kinase-myocardial band (CK-MB) \\[µg\u002FL\\]",{"measure":48,"description":49,"timeFrame":14},{"measure":52,"description":53,"timeFrame":12},"Aspartate aminotransferase [µg\u002FL]","Markers of myocardial ischemia and heart failure:\n\nAspartate aminotransferase \\[µg\u002FL\\]",{"measure":52,"description":53,"timeFrame":14},{"measure":56,"description":57,"timeFrame":12},"Lactate dehydrogenase [µg\u002FL]","Markers of myocardial ischemia and heart failure:\n\nLactate dehydrogenase \\[µg\u002FL\\]",{"measure":56,"description":57,"timeFrame":14},{"measure":60,"description":61,"timeFrame":12},"N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg\u002FL]","Markers of myocardial ischemia and heart failure:\n\nN-terminal pro-B-type natriuretic peptide (NT-proBNP) \\[µg\u002FL\\]",{"measure":60,"description":61,"timeFrame":14},{"measure":64,"description":65,"timeFrame":12},"High-sensitive C-reactive protein (CRP) [µg\u002FL]","Cytokines and inflammation markers:\n\nHigh-sensitive C-reactive protein (CRP) \\[µg\u002FL\\]",{"measure":64,"description":65,"timeFrame":14},{"measure":68,"description":69,"timeFrame":12},"Procalcitonin (PCT) [µg\u002FL]","Cytokines and inflammation markers:\n\nProcalcitonin (PCT) \\[µg\u002FL\\]",{"measure":68,"description":69,"timeFrame":14},{"measure":72,"description":73,"timeFrame":12},"Interleukin 6 (IL-6) [µg\u002FL]","Cytokines and inflammation markers:\n\nInterleukin 6 (IL-6) \\[µg\u002FL\\]",{"measure":72,"description":73,"timeFrame":14},null,{"allocation":75,"interventionModel":75,"interventionModelDescription":75,"primaryPurpose":75,"observationalModel":77,"timePerspective":78,"maskingInfo":75},"COHORT","PROSPECTIVE","The primary aim of the current study is a better understanding of the role of Type 2 Diabetes Mellitus (T2DM) in heart failure and, in particular, changes in cardiac metabolism, which may contribute to heart failure. Various biomarkers in the coronary artery blood, as well as in the arterial and peripheral venous blood, are to be identified for this purpose. Included are patients with and without T2DM, who have a clinically indicated and guidance-appropriate Cardiac Resynchronisation Therapy (CRT) implantation due to their cardiac insufficiency and patients who have a clinically indicated electrophysiological examination (EPU) or pulmonary vein ablation (PVI).\n\nNot all patients currently benefit from the implantation of a CRT system (so-called non-responder). Despite narrow inclusion criteria, these \"non-responders\" cannot be unmasked in advance of the implantation. Thus, a further aim of this study is to identify biomarkers, which can be determined in advance of implantation to differentiate between responders and non-responders.\n\nPatient selection is based on the previously defined inclusion and exclusion criteria. The patient is informed by the physician and gives written consent to participate in the study. Prior to the implantation of the CRT system\u002Fthe electrophysiological examination(EPU)\u002Fpulmonary vein ablation(PVI), the patient first responds to a study-related questionnaire and performs a 6-minute walk test.\n\nAfterwards the clinically indicated, elective CRT implantation\u002FEPU\u002FPVI is performed by experienced physicians of the Medical Clinic I. Routinely, an arterial pressure catheter for invasive blood pressure monitoring (usually arteria radialis) is inserted. In addition, 2 peripheral venous accesses are established. The system of the CRT system is carried out via a small pectoral section. The cardiac probes are inserted into the heart via the subclavian vein. First, the probe is implanted in the right ventricle and, if necessary, a probe is placed in the right atrium. For EPU\u002FPVI a femoral vein acsess is established.\n\nTo establish the coronary sinus (CS) probe, the intubation of the coronary sinus is performed by means of a guide catheter, which can be used to take blood samples. After intubation of the coronary sinus, the coronary artery blood is taken from the guide catheter for the study as well as arterially via the underlying pressure catheter as well as peripheral venous over a horizontal venous catheter. During EPU\u002FPVI the coronary sinus has also to be intubated due to the ablation protocol. The blood sampling does not take more than 1-2 minutes.\n\nThe surgery is then terminated as planned and postoperative care is performed according to the standard operation procedure (SOP) of the Medical Clinic I. Within the framework of a control visit routinely performed in the Medical Clinic I , an echocardiographic follow-up of heart failure, a history assessment and a laboratory-based blood analysis are performed 6 months after CRT implantation. In the context of this visit peripheral venous blood is collected again for the study. In addition, the 6-minute walk test is performed once more and the patient receives the same questionnaire again.\n\nLaboratory routine blood analysis is performed in the central laboratory of the University Hospital of Aachen and is independent of the study. The analysis measures standard parameters such as electrolytes, blood count, retention parameters, glucose, HbA1c, liver values, N-terminal Brain Natriuretic Peptide (NT-pro-BNP) etc. .\n\nA blood gas analysis of the study blood is performed out first. The remaining blood is processed and stored at -80 ° C, so-called \"biobank\", for further biomarker analysis, e.g. metabolite analysis, peptides\u002Fproteins and RNA.","Patients with and without heart failure (HFrEF, HFmrEF, HFpEF) plus known status of type 2 diabetes (yes\u002Fno)",[82,89,93],{"label":83,"type":75,"description":84,"interventionNames":85},"No diabetes","Patients without diabetes",[86,87,88],"Diagnostic Test: 6-minute walk test","Diagnostic Test: Study specific questionnaire","Procedure: Blood collection",{"label":90,"type":75,"description":91,"interventionNames":92},"Type 2 diabetes","Patients with diagnosis of type 2 diabetes (new\u002Festablished)",[86,87,88],{"label":94,"type":75,"description":95,"interventionNames":96},"Prediabetes","Patients with an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold.",[86,87,88],[98,103,107],{"type":99,"name":100,"description":101,"armGroupLabels":102,"otherNames":75},"DIAGNOSTIC_TEST","6-minute walk test","The 6-minute walk test is a functional test established in the clinic to assess the performance of a patient. The patient walks continuously for 6 minutes without interruption as far as possible. Breaks, speed changes and running are allowed.\n\nTest is performed prior the intervention and 6 months after the intervention.",[83,94,90],{"type":99,"name":104,"description":105,"armGroupLabels":106,"otherNames":75},"Study specific questionnaire","Study specific questionnaire\n\nThe questionnaire is performed prior and 6 months after the intervention.",[83,94,90],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":75},"PROCEDURE","Blood collection","Blood collection during surgery:\n\n* coronary sinus\n* arterial\n* peripheral venous\n\nBlood collection 6 months after surgery:\n\n\\- peripheral venous",[83,94,90],[113],{"name":114,"affiliation":115,"role":116},"Ben Kappel, MD PhD","Uniklinik RWTH Aachen","PRINCIPAL_INVESTIGATOR",[118,122],{"name":114,"role":119,"phone":120,"phoneExt":75,"email":121},"CONTACT","0241 800","bakppel@ukaachen.de",{"name":123,"role":119,"phone":124,"phoneExt":75,"email":125},"Christina Kalvelage, M. Sc.","0241 80 36485","ckalvelage@ukaachen.de",[127],{"facility":128,"status":129,"city":130,"state":131,"zip":132,"country":133,"countryCode":134,"cosmosGeoPoint":135,"geoPoint":140,"contacts":141},"University Hospital RWTH Aachen","RECRUITING","Aachen","North Rhine-Westphalia","52074","Germany","DE",{"type":136,"coordinates":137},"Point",[138,139],6.08342,50.77664,{"lat":139,"lon":138},[142],{"name":143,"role":119,"phone":75,"phoneExt":75,"email":75},"Ben A Kappel, MD PhD",{"type":116,"investigatorFullName":145,"investigatorTitle":146,"investigatorAffiliation":5,"oldNameTitle":75,"oldOrganization":75},"Ben Kappel","Principal Investigator","100310579",false,"NCT03323216","BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure","BIO-2-HEART Study (Identifying New BIOmarkers in Patients With Type 2 Diabetes Mellitus and HEArt Failure Receiving Cardiac Resynchronization Therapy Device Implantation)","BIO-2-HEART","Inclusion Criteria:\n\n1. guideline-appropriate clinical indication for CRT implantation\u002Felectrophysiologial examination\u002Fpulmonary vein ablation\n2. age of majority\n3. written declaration of consent\n4. persons who are able to work and mentally able to follow the instructions of the study staff\n5. free access routes\n\nExclusion Criteria:\n\n1. anemia Hb \\\u003C8 mg \u002F dl\n2. patients with acute infectious disease (e.g. pneumonia)\n3. non-intubatable coronary sinus\n4. patients who do not have access to the subclavian vein (e.g. thrombosis of the subclavian vein or superior vena cava)\n5. patients with idiopathic hypertrophic, restrictive or constrictive cardiomyopathy, or heart failure due to a known inflammatory or infiltrating disease (e.g. amyloidosis, sarcoidosis) or a constrictive disease\n6. patients with heart failure by sepsis\n7. persons with acute myocardial ischaemia, e.g. by angina pectoris or ECG changes under load\n8. patients with acute coronary syndrome are not implanted in the past 3 months\n9. patients who were hospitalized during the last month due to heart failure and who had to be treated intravenously with diuretics or inotropic substances\n10. patients with mechanical aortic valve or tricuspid valve\n11. patients with heart transplant.\n12. patients with acute liver or renal failure\n13. pregnant and lactating women\n14. patients placed under an official or judicial order in an institution\n15. patients who are in a dependency or employment relationship with the sponsor or auditor\n16. taking an investigational medicinal product 30 days before the start of the study","ALL","18 Years",{"count":157,"type":158},400,"ESTIMATED","OBSERVATIONAL","The primary aim of the current study is a better understanding of the role of Type 2 Diabetes Mellitus (T2DM) in heart failure and, in particular, changes in cardiac metabolism, which may contribute to heart failure. Various biomarkers in the coronary artery blood, as well as in the arterial and peripheral venous blood, are to be identified for this purpose. Included are patients with and without T2DM and with or without heart failure (HFpEF, HFmrEF, HFrEF), who have a clinically indicated and guidance-appropriate Cardiac Resynchronisation Therapy (CRT) implantation or pulmonary vein ablation\u002Felectrophysiological examination.\n\nNot all patients currently benefit from the implantation of a CRT system (so-called non-responder). Despite narrow inclusion criteria, these \"non-responders\" cannot be unmasked in advance of the implantation. A further aim of this study is to identify biomarkers, which can be determined in advance of implantation to differentiate between responders and non-responders.",[162,163],"Heart Failure","Diabetes Mellitus, Type 2","2024-05-07",{"date":166,"type":167},"2024-05-09","ACTUAL",{"date":169,"type":167},"2018-04-01",{"date":171,"type":158},"2026-12-31",{"name":5,"class":6},1]