RecruitingNCT03323216

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

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


Sponsor

RWTH Aachen University

Enrollment

400 participants

Start Date

Apr 1, 2018

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for biological markers in the blood and heart of patients with Type 2 diabetes (T2DM) and heart failure — two conditions that often occur together — to better understand how they interact and find new ways to treat them. **You may be eligible if...** - You have a medical need for a heart device procedure (CRT implant, electrophysiology study, or ablation for irregular heartbeat) - You are of legal adult age in your country - You can follow the study instructions and give written consent **You may NOT be eligible if...** - You are unable to understand and follow study instructions - You are unwilling to give consent - You are a minor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST6-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_TESTStudy specific questionnaire

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

PROCEDUREBlood 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

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NCT03323216


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