6-minute walk testStudy specific questionnaireBlood collection
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.
Test is performed prior the intervention and 6 months after the intervention.
Study specific questionnaire: Study specific questionnaire
The questionnaire is performed prior and 6 months after the intervention.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. guideline-appropriate clinical indication for CRT implantation/electrophysiologial examination/pulmonary vein ablation
2. age of majority
3. written declaration of consent
4. persons who are able to work and mentally able to follow the instructions of the study staff
5. free access routes
Exclusion Criteria:
1. anemia Hb \<8 mg / dl
2. patients with acute infectious disease (e.g. pneumonia)
3. non-intubatable coronary sinus
4. patients who do not have access to the subclavian vein (e.g. thrombosis of the subclavian vein or superior vena cava)
5. 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
6. patients with heart failure by sepsis
7. persons with acute myocardial ischaemia, e.g. by angina pectoris or ECG changes under load
8. patients with acute coronary syndrome are not implanted in the past 3 months
9. patients who were hospitalized during the last month due to heart failure and who had to be treated intravenously with diuretics or inotropic substances
10. patients with mechanical aortic valve or tricuspid valve
11. patients with heart transplant.
12. patients with acute liver or renal failure
13. pregnant and lactating women
14. patients placed under an official or judicial order in an institution
15. patients who are in a dependency or employment relationship with the sponsor or auditor
16. taking an investigational medicinal product 30 days before the start of the study
Primary outcome measure(s)
Oxygen partial pressure (pO2) [mmHg] — Directly prior to the CRT-implantation Results of blood gas analysis:
Oxygen partial pressure (pO2) \[mmHg\]
Oxygen partial pressure (pO2) [mmHg] — 6 months after CRT-implantation Results of blood gas analysis:
Oxygen partial pressure (pO2) \[mmHg\]
Carbon dioxide partial pressure (pCO2) [mmHg] — Directly prior to the CRT-implantation Results of blood gas analysis:
Carbon dioxide partial pressure (pCO2) \[mmHg\]
Carbon dioxide partial pressure (pCO2) [mmHg] — 6 months after CRT-implantation Results of blood gas analysis:
Carbon dioxide partial pressure (pCO2) \[mmHg\]
potential of hydrogen (pH) value [-] — Directly prior to the CRT-implantation Results of blood gas analysis:
pH value \[-\]
potential of hydrogen (pH) value [-] — 6 months after CRT-implantation Results of blood gas analysis:
pH value \[-\]
Base excess [mmol] — Directly prior to the CRT-implantation Results of blood gas analysis:
Base excess \[mmol\]
Base excess [mmol] — 6 months after CRT-implantation Results of blood gas analysis:
Base excess \[mmol\]
Lactate [mmol/l] — Directly prior to the CRT-implantation Results of blood gas analysis:
Lactate \[mmol/l\]
Lactate [mmol/l] — 6 months after CRT-implantation Results of blood gas analysis:
Lactate \[mmol/l\]
Glucose [mg/dl] — Directly prior to the CRT-implantation Results of blood gas analysis:
Glucose \[mg/dl\]
Glucose [mg/dl] — 6 months after CRT-implantation Results of blood gas analysis:
Glucose \[mg/dl\]
Electrolytes (K+, Na2+, Ca2+) [mmol/l] — Directly prior to the CRT-implantation Results of blood gas analysis:
Electrolytes (K+, Na2+, Ca2+) \[mmol/l\]
Electrolytes (K+, Na2+, Ca2+) [mmol/l] — 6 months after CRT-implantation Results of blood gas analysis:
Electrolytes (K+, Na2+, Ca2+) \[mmol/l\]
High-sensitive troponin T [µg/L] — Directly prior to the CRT-implantation Markers of myocardial ischemia and heart failure:
High-sensitive troponin T \[µg/L\]
High-sensitive troponin T [µg/L] — 6 months after CRT-implantation Markers of myocardial ischemia and heart failure:
High-sensitive troponin T \[µg/L\]
Total creatine kinase [µg/L] — Directly prior to the CRT-implantation Markers of myocardial ischemia and heart failure:
Total creatine kinase \[µg/L\]
Total creatine kinase [µg/L] — 6 months after CRT-implantation Markers of myocardial ischemia and heart failure:
Total creatine kinase \[µg/L\]
Creatinine kinase-myocardial band (CK-MB) [µg/L] — Directly prior to the CRT-implantation Markers of myocardial ischemia and heart failure:
Creatinine kinase-myocardial band (CK-MB) \[µg/L\]
Creatinine kinase-myocardial band (CK-MB) [µg/L] — 6 months after CRT-implantation Markers of myocardial ischemia and heart failure:
Creatinine kinase-myocardial band (CK-MB) \[µg/L\]
Aspartate aminotransferase [µg/L] — Directly prior to the CRT-implantation Markers of myocardial ischemia and heart failure:
Aspartate aminotransferase \[µg/L\]
Aspartate aminotransferase [µg/L] — 6 months after CRT-implantation Markers of myocardial ischemia and heart failure:
Aspartate aminotransferase \[µg/L\]
Lactate dehydrogenase [µg/L] — Directly prior to the CRT-implantation Markers of myocardial ischemia and heart failure:
Lactate dehydrogenase \[µg/L\]
Lactate dehydrogenase [µg/L] — 6 months after CRT-implantation Markers of myocardial ischemia and heart failure:
Lactate dehydrogenase \[µg/L\]
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L] — Directly prior to the CRT-implantation Markers of myocardial ischemia and heart failure:
N-terminal pro-B-type natriuretic peptide (NT-proBNP) \[µg/L\]
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L] — 6 months after CRT-implantation Markers of myocardial ischemia and heart failure:
N-terminal pro-B-type natriuretic peptide (NT-proBNP) \[µg/L\]
High-sensitive C-reactive protein (CRP) [µg/L] — Directly prior to the CRT-implantation Cytokines and inflammation markers:
High-sensitive C-reactive protein (CRP) \[µg/L\]
High-sensitive C-reactive protein (CRP) [µg/L] — 6 months after CRT-implantation Cytokines and inflammation markers:
High-sensitive C-reactive protein (CRP) \[µg/L\]
Procalcitonin (PCT) [µg/L] — Directly prior to the CRT-implantation Cytokines and inflammation markers:
Procalcitonin (PCT) \[µg/L\]
Procalcitonin (PCT) [µg/L] — 6 months after CRT-implantation Cytokines and inflammation markers:
Procalcitonin (PCT) \[µg/L\]
Interleukin 6 (IL-6) [µg/L] — Directly prior to the CRT-implantation Cytokines and inflammation markers:
Interleukin 6 (IL-6) \[µg/L\]
Interleukin 6 (IL-6) [µg/L] — 6 months after CRT-implantation Cytokines and inflammation markers:
Interleukin 6 (IL-6) \[µg/L\]
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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