Identifying biomarkers in patients with Type 2 Diabetes 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)
This study is trying to find specific markers in the blood of people with Type 2 Diabetes and heart failure to see if they can help predict who will benefit from a heart treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RWTH Aachen University Academic / other |
| Locations | 1 site (Aachen, North Rhine-Westphalia) |
| Trial ID | NCT03323216 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance the understanding of how Type 2 Diabetes Mellitus (T2DM) affects heart failure, particularly focusing on changes in cardiac metabolism. It involves identifying various biomarkers in blood samples from patients with and without T2DM who are undergoing Cardiac Resynchronisation Therapy (CRT) implantation or electrophysiological examinations. Participants will complete a study-specific questionnaire and a 6-minute walk test prior to their procedures. The study seeks to differentiate between responders and non-responders to CRT by identifying predictive biomarkers.
Who should consider this trial
Good fit: Ideal candidates include adults with a clinical indication for CRT implantation or electrophysiological examination, regardless of their T2DM status.
Not a fit: Patients with acute infectious diseases, severe anemia, or specific cardiomyopathies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient selection for CRT, enhancing treatment outcomes for those with heart failure and T2DM.
How similar studies have performed: While the approach of identifying biomarkers in this context is promising, it is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aachen, North Rhine-Westphalia
- University Hospital RWTH Aachen — Aachen, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Ben Kappel, MD PhD — Uniklinik RWTH Aachen
- Study coordinator: Ben Kappel, MD PhD
- Email: bakppel@ukaachen.de
- Phone: 0241 800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.