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BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure

Recruitingn/aAges 18 Years - anyAllRWTH Aachen University
NCT03323216 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, w

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📋 Eligibility rules (as published)
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
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What it tests

  • 6-minute walk test
  • Study specific questionnaire
  • Blood collection
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Where

1 site
University Hospital RWTH Aachen
Aachen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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