Identifying biomarkers in patients with Type 2 Diabetes and heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.