An observational study in Heart Failure and Diabetes Mellitus, Type 2, sponsored by RWTH Aachen University. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by RWTH Aachen University · 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/electrophysiological examination.
Not 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.
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).
Not 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.
Patient 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/the electrophysiological examination(EPU)/pulmonary vein ablation(PVI), the patient first responds to a study-related questionnaire and performs a 6-minute walk test.
Afterwards the clinically indicated, elective CRT implantation/EPU/PVI 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/PVI a femoral vein acsess is established.
To 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/PVI the coronary sinus has also to be intubated due to the ablation protocol. The blood sampling does not take more than 1-2 minutes.
The 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.
Laboratory 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. .
A 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/proteins and RNA.
Patients with and without heart failure (HFrEF, HFmrEF, HFpEF) plus known status of type 2 diabetes (yes/no)
Exclusion Criteria:
Patients without diabetes
Diagnostic Test: 6-minute walk test · Diagnostic Test: Study specific questionnaire · Procedure: Blood collection
Patients with diagnosis of type 2 diabetes (new/established)
Diagnostic Test: 6-minute walk test · Diagnostic Test: Study specific questionnaire · Procedure: Blood collection
Patients with an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold.
Diagnostic Test: 6-minute walk test · Diagnostic Test: Study specific questionnaire · Procedure: Blood collection
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. Test is performed prior the intervention and 6 months after the intervention.
Study specific questionnaire The questionnaire is performed prior and 6 months after the intervention.
Blood collection during surgery: * coronary sinus * arterial * peripheral venous Blood collection 6 months after surgery: - peripheral venous
Oxygen partial pressure (pO2) [mmHg]
Results of blood gas analysis: Oxygen partial pressure (pO2) \[mmHg\]
Time frame: Directly prior to the CRT-implantation
Oxygen partial pressure (pO2) [mmHg]
Results of blood gas analysis: Oxygen partial pressure (pO2) \[mmHg\]
Time frame: 6 months after CRT-implantation
Carbon dioxide partial pressure (pCO2) [mmHg]
Results of blood gas analysis: Carbon dioxide partial pressure (pCO2) \[mmHg\]
Time frame: Directly prior to the CRT-implantation
Carbon dioxide partial pressure (pCO2) [mmHg]
Results of blood gas analysis: Carbon dioxide partial pressure (pCO2) \[mmHg\]
Time frame: 6 months after CRT-implantation
potential of hydrogen (pH) value [-]
Results of blood gas analysis: pH value \[-\]
Time frame: Directly prior to the CRT-implantation
potential of hydrogen (pH) value [-]
Results of blood gas analysis: pH value \[-\]
Time frame: 6 months after CRT-implantation
Base excess [mmol]
Results of blood gas analysis: Base excess \[mmol\]
Time frame: Directly prior to the CRT-implantation
Base excess [mmol]
Results of blood gas analysis: Base excess \[mmol\]
Time frame: 6 months after CRT-implantation
Lactate [mmol/l]
Results of blood gas analysis: Lactate \[mmol/l\]
Time frame: Directly prior to the CRT-implantation
Lactate [mmol/l]
Results of blood gas analysis: Lactate \[mmol/l\]
Time frame: 6 months after CRT-implantation
Glucose [mg/dl]
Results of blood gas analysis: Glucose \[mg/dl\]
Time frame: Directly prior to the CRT-implantation
Glucose [mg/dl]
Results of blood gas analysis: Glucose \[mg/dl\]
Time frame: 6 months after CRT-implantation
Electrolytes (K+, Na2+, Ca2+) [mmol/l]
Results of blood gas analysis: Electrolytes (K+, Na2+, Ca2+) \[mmol/l\]
Time frame: Directly prior to the CRT-implantation
Electrolytes (K+, Na2+, Ca2+) [mmol/l]
Results of blood gas analysis: Electrolytes (K+, Na2+, Ca2+) \[mmol/l\]
Time frame: 6 months after CRT-implantation
High-sensitive troponin T [µg/L]
Markers of myocardial ischemia and heart failure: High-sensitive troponin T \[µg/L\]
Time frame: Directly prior to the CRT-implantation
High-sensitive troponin T [µg/L]
Markers of myocardial ischemia and heart failure: High-sensitive troponin T \[µg/L\]
Time frame: 6 months after CRT-implantation
Total creatine kinase [µg/L]
Markers of myocardial ischemia and heart failure: Total creatine kinase \[µg/L\]
Time frame: Directly prior to the CRT-implantation
Total creatine kinase [µg/L]
Markers of myocardial ischemia and heart failure: Total creatine kinase \[µg/L\]
Time frame: 6 months after CRT-implantation
Creatinine kinase-myocardial band (CK-MB) [µg/L]
Markers of myocardial ischemia and heart failure: Creatinine kinase-myocardial band (CK-MB) \[µg/L\]
Time frame: Directly prior to the CRT-implantation
Creatinine kinase-myocardial band (CK-MB) [µg/L]
Markers of myocardial ischemia and heart failure: Creatinine kinase-myocardial band (CK-MB) \[µg/L\]
Time frame: 6 months after CRT-implantation
Aspartate aminotransferase [µg/L]
Markers of myocardial ischemia and heart failure: Aspartate aminotransferase \[µg/L\]
Time frame: Directly prior to the CRT-implantation
Aspartate aminotransferase [µg/L]
Markers of myocardial ischemia and heart failure: Aspartate aminotransferase \[µg/L\]
Time frame: 6 months after CRT-implantation
Lactate dehydrogenase [µg/L]
Markers of myocardial ischemia and heart failure: Lactate dehydrogenase \[µg/L\]
Time frame: Directly prior to the CRT-implantation
Lactate dehydrogenase [µg/L]
Markers of myocardial ischemia and heart failure: Lactate dehydrogenase \[µg/L\]
Time frame: 6 months after CRT-implantation
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]
Markers of myocardial ischemia and heart failure: N-terminal pro-B-type natriuretic peptide (NT-proBNP) \[µg/L\]
Time frame: Directly prior to the CRT-implantation
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]
Markers of myocardial ischemia and heart failure: N-terminal pro-B-type natriuretic peptide (NT-proBNP) \[µg/L\]
Time frame: 6 months after CRT-implantation
High-sensitive C-reactive protein (CRP) [µg/L]
Cytokines and inflammation markers: High-sensitive C-reactive protein (CRP) \[µg/L\]
Time frame: Directly prior to the CRT-implantation
High-sensitive C-reactive protein (CRP) [µg/L]
Cytokines and inflammation markers: High-sensitive C-reactive protein (CRP) \[µg/L\]
Time frame: 6 months after CRT-implantation
Procalcitonin (PCT) [µg/L]
Cytokines and inflammation markers: Procalcitonin (PCT) \[µg/L\]
Time frame: Directly prior to the CRT-implantation
Procalcitonin (PCT) [µg/L]
Cytokines and inflammation markers: Procalcitonin (PCT) \[µg/L\]
Time frame: 6 months after CRT-implantation
Interleukin 6 (IL-6) [µg/L]
Cytokines and inflammation markers: Interleukin 6 (IL-6) \[µg/L\]
Time frame: Directly prior to the CRT-implantation
Interleukin 6 (IL-6) [µg/L]
Cytokines and inflammation markers: Interleukin 6 (IL-6) \[µg/L\]
Time frame: 6 months after CRT-implantation
Plan to share: No
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RWTH Aachen University