Status:
RECRUITING
BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure
Lead Sponsor:
RWTH Aachen University
Conditions:
Heart Failure
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
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 t...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- guideline-appropriate clinical indication for CRT implantation/electrophysiologial examination/pulmonary vein ablation
- age of majority
- written declaration of consent
- persons who are able to work and mentally able to follow the instructions of the study staff
- free access routes
Exclusion
- anemia Hb \<8 mg / dl
- patients with acute infectious disease (e.g. pneumonia)
- non-intubatable coronary sinus
- patients who do not have access to the subclavian vein (e.g. thrombosis of the subclavian vein or superior vena cava)
- 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
- patients with heart failure by sepsis
- persons with acute myocardial ischaemia, e.g. by angina pectoris or ECG changes under load
- patients with acute coronary syndrome are not implanted in the past 3 months
- patients who were hospitalized during the last month due to heart failure and who had to be treated intravenously with diuretics or inotropic substances
- patients with mechanical aortic valve or tricuspid valve
- patients with heart transplant.
- patients with acute liver or renal failure
- pregnant and lactating women
- patients placed under an official or judicial order in an institution
- patients who are in a dependency or employment relationship with the sponsor or auditor
- taking an investigational medicinal product 30 days before the start of the study
Key Trial Info
Start Date :
April 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT03323216
Start Date
April 1 2018
End Date
December 31 2026
Last Update
May 9 2024
Active Locations (1)
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1
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany, 52074