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RECRUITING
NCT03323216

BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure

Sponsor: RWTH Aachen University

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Study specific questionnaire

Study specific questionnaire The questionnaire is performed prior and 6 months after the intervention.

PROCEDURE

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