Actively Recruiting
BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure
Led by RWTH Aachen University · Updated on 2024-05-09
400
Participants Needed
1
Research Sites
456 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Guideline-appropriate clinical indication for CRT implantation, electrophysiological examination, or pulmonary vein ablation
- Age 18 years or older
- Written informed consent
- Able to work and mentally capable of following study instructions
- Free access routes for procedures and blood sampling
You will not qualify if you...
- Hemoglobin level less than 8 mg/dl (anemia)
- Acute infectious diseases such as pneumonia
- Coronary sinus that cannot be intubated
- No access to subclavian vein (e.g., thrombosis)
- Idiopathic hypertrophic, restrictive, or constrictive cardiomyopathy, or heart failure due to inflammatory or infiltrative diseases
- Heart failure caused by sepsis
- Acute myocardial ischemia or angina pectoris or ECG changes under load
- Acute coronary syndrome within the past 3 months
- Hospitalization for heart failure requiring intravenous diuretics or inotropic treatment within the last month
- Mechanical aortic or tricuspid valve
- Heart transplant recipient
- Acute liver or kidney failure
- Pregnant or breastfeeding women
- Patients under official or judicial institutional orders
- Employees or dependents of the study sponsor or auditor
- Use of investigational medicinal product within 30 days before study start
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany, 52074
Actively Recruiting
Research Team
B
Ben Kappel, MD PhD
CONTACT
C
Christina Kalvelage, M. Sc.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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