BIO-2-HEART Study (Identifying New BIOmarkers in Patients With Type 2 Diabetes Mellitus and HEArt Failure Receiving Cardiac Resynchronization Therapy Device Implantation)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
University Hospital RWTH Aachen
RECRUITING
Aachen
Contact Information
Primary
Ben Kappel, MD PhD
bakppel@ukaachen.de
0241 800
Backup
Christina Kalvelage, M. Sc.
ckalvelage@ukaachen.de
0241 80 36485
Time Frame
Start Date: 2018-04-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 400
Treatments
No diabetes
Patients without diabetes
Type 2 diabetes
Patients with diagnosis of type 2 diabetes (new/established)
Prediabetes
Patients with an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold.
Related Therapeutic Areas
Sponsors
Leads: RWTH Aachen University

This content was sourced from clinicaltrials.gov