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BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure
Sponsor: RWTH Aachen University
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.
Official title: BIO-2-HEART Study (Identifying New BIOmarkers in Patients With Type 2 Diabetes Mellitus and HEArt Failure Receiving Cardiac Resynchronization Therapy Device Implantation)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
400
Start Date
2018-04-01
Completion Date
2026-12-31
Last Updated
2024-05-09
Healthy Volunteers
No
Conditions
Interventions
6-minute walk test
The 6-minute walk test is a functional test established in the clinic to assess the performance of a patient. The patient walks continuously for 6 minutes without interruption as far as possible. Breaks, speed changes and running are allowed. Test is performed prior the intervention and 6 months after the intervention.
Study specific questionnaire
Study specific questionnaire The questionnaire is performed prior and 6 months after the intervention.
Blood collection
Blood collection during surgery: * coronary sinus * arterial * peripheral venous Blood collection 6 months after surgery: \- peripheral venous
Locations (1)
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, Germany