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

NCT03323216 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-05-09

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Ben Kappel, MD PhD · Uniklinik RWTH Aachen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03323216 on ClinicalTrials.gov