BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRWTH Aachen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Patients with and without heart failure (HFrEF, HFmrEF, HFpEF) plus known status of type 2 diabetes (yes/no)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
6-minute walk test
Diagnostic testThe 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.
Study specific questionnaire
Diagnostic testStudy specific questionnaire The questionnaire is performed prior and 6 months after the intervention.
Blood collection
Procedure/SurgeryBlood collection during surgery: * coronary sinus * arterial * peripheral venous Blood collection 6 months after surgery: \- peripheral venous
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: No diabetes3 interventions
Group B: Type 2 diabetes3 interventions
Group C: Prediabetes3 interventions
Trial outcomes
Primary outcomes
1
Oxygen partial pressure (pO2) [mmHg]
Results of blood gas analysis: Oxygen partial pressure (pO2) \[mmHg\]
Time frame
Directly prior to the CRT-implantation2
Oxygen partial pressure (pO2) [mmHg]
Results of blood gas analysis: Oxygen partial pressure (pO2) \[mmHg\]
Time frame
6 months after CRT-implantation3
Carbon dioxide partial pressure (pCO2) [mmHg]
Results of blood gas analysis: Carbon dioxide partial pressure (pCO2) \[mmHg\]
Time frame
Directly prior to the CRT-implantation4
Carbon dioxide partial pressure (pCO2) [mmHg]
Results of blood gas analysis: Carbon dioxide partial pressure (pCO2) \[mmHg\]
Time frame
6 months after CRT-implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov