NCT03323216Recruiting
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)
Source: ClinicalTrials.gov · Last updated 9 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 26 Sept 2017
- Start date
- 1 Apr 2018
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- RWTH Aachen University
- Diseases
- Heart failure, Type 2 diabetes
- NCT number
- NCT03323216
What you commit to
- Study type: Observational
- Planned participants: 400
- From 1 Apr 2018 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- taking an investigational medicinal product 30 days before the start of the study
Other illness
- patients with acute infectious disease (e.g. pneumonia)
- 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 heart transplant.
- patients with acute liver or renal failure
Other
- anemia Hb \<8 mg / dl
- non-intubatable coronary sinus
- patients with mechanical aortic valve or tricuspid valve
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Rwth Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.