NCT03323216 BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure
| NCT ID | NCT03323216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RWTH Aachen University |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2018-04-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2018-04-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 Criteria
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
Contact & Investigator
Ben Kappel, MD PhD
PRINCIPAL INVESTIGATOR
Uniklinik RWTH Aachen
Frequently Asked Questions
Who can join the NCT03323216 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03323216 currently recruiting?
Yes, NCT03323216 is actively recruiting participants. Contact the research team at bakppel@ukaachen.de for enrollment information.
Where is the NCT03323216 trial being conducted?
This trial is being conducted at Aachen, Germany.
Who is sponsoring the NCT03323216 clinical trial?
NCT03323216 is sponsored by RWTH Aachen University. The principal investigator is Ben Kappel, MD PhD at Uniklinik RWTH Aachen. The trial plans to enroll 400 participants.
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