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

Recruiting now

Conditions studied: Heart Failure, Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03323216

Run by

RWTH Aachen University

People needed

400

Starts

2018-04-01

Expected to finish

2026-12-31

Last updated by the study team

2024-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• anemia Hb <8 mg / dl
• patients with acute infectious disease (e.g. pneumonia)
• non-intubatable coronary sinus
• patients who do not have access to the subclavian vein (e.g. thrombosis of the subclavian vein or superior vena cava)
• patients with idiopathic hypertrophic, restrictive or constrictive cardiomyopathy, or heart failure due to a known inflammatory or infiltrating disease (e.g. amyloidosis, sarcoidosis) or a constrictive disease
• patients with heart failure by sepsis
• persons with acute myocardial ischaemia, e.g. by angina pectoris or ECG changes under load
• patients with acute coronary syndrome are not implanted in the past 3 months
• patients who were hospitalized during the last month due to heart failure and who had to be treated intravenously with diuretics or inotropic substances
• patients with mechanical aortic valve or tricuspid valve
• patients with heart transplant.
• patients with acute liver or renal failure
• pregnant and lactating women
• patients placed under an official or judicial order in an institution
• patients who are in a dependency or employment relationship with the sponsor or auditor
• taking an investigational medicinal product 30 days before the start of the study

Where it is running

• University Hospital RWTH Aachen — Aachen, North Rhine-Westphalia, Germany (enrolling)

Full record on ClinicalTrials.gov

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