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NCT Number: NCT03323216

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location status: Recruiting

Location contact

Ben A Kappel, MD PhD

CONTACT

About this study

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, who have a clinically indicated and guidance-appropriate Cardiac Resynchronisation Therapy (CRT) implantation due to their cardiac insufficiency and patients who have a clinically indicated electrophysiological examination (EPU) or pulmonary vein ablation (PVI).

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. Thus, 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.

Patient selection is based on the previously defined inclusion and exclusion criteria. The patient is informed by the physician and gives written consent to participate in the study. Prior to the implantation of the CRT system/the electrophysiological examination(EPU)/pulmonary vein ablation(PVI), the patient first responds to a study-related questionnaire and performs a 6-minute walk test.

Afterwards the clinically indicated, elective CRT implantation/EPU/PVI is performed by experienced physicians of the Medical Clinic I. Routinely, an arterial pressure catheter for invasive blood pressure monitoring (usually arteria radialis) is inserted. In addition, 2 peripheral venous accesses are established. The system of the CRT system is carried out via a small pectoral section. The cardiac probes are inserted into the heart via the subclavian vein. First, the probe is implanted in the right ventricle and, if necessary, a probe is placed in the right atrium. For EPU/PVI a femoral vein acsess is established.

To establish the coronary sinus (CS) probe, the intubation of the coronary sinus is performed by means of a guide catheter, which can be used to take blood samples. After intubation of the coronary sinus, the coronary artery blood is taken from the guide catheter for the study as well as arterially via the underlying pressure catheter as well as peripheral venous over a horizontal venous catheter. During EPU/PVI the coronary sinus has also to be intubated due to the ablation protocol. The blood sampling does not take more than 1-2 minutes.

The surgery is then terminated as planned and postoperative care is performed according to the standard operation procedure (SOP) of the Medical Clinic I. Within the framework of a control visit routinely performed in the Medical Clinic I , an echocardiographic follow-up of heart failure, a history assessment and a laboratory-based blood analysis are performed 6 months after CRT implantation. In the context of this visit peripheral venous blood is collected again for the study. In addition, the 6-minute walk test is performed once more and the patient receives the same questionnaire again.

Laboratory routine blood analysis is performed in the central laboratory of the University Hospital of Aachen and is independent of the study. The analysis measures standard parameters such as electrolytes, blood count, retention parameters, glucose, HbA1c, liver values, N-terminal Brain Natriuretic Peptide (NT-pro-BNP) etc. .

A blood gas analysis of the study blood is performed out first. The remaining blood is processed and stored at -80 ° C, so-called "biobank", for further biomarker analysis, e.g. metabolite analysis, peptides/proteins and RNA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

6-minute walk test

Diagnostic 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.

Study specific questionnaire

Diagnostic Test

Study specific questionnaire

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

Blood Collection

Procedure

Blood collection during surgery:

  • coronary sinus
  • arterial
  • peripheral venous

Blood collection 6 months after surgery:

  • peripheral venous

Primary outcomes

  1. Oxygen partial pressure (pO2) [mmHg]

    Time frame: Directly prior to the CRT-implantation

    Results of blood gas analysis:

    Oxygen partial pressure (pO2) [mmHg]

  2. Oxygen partial pressure (pO2) [mmHg]

    Time frame: 6 months after CRT-implantation

    Results of blood gas analysis:

    Oxygen partial pressure (pO2) [mmHg]

  3. Carbon dioxide partial pressure (pCO2) [mmHg]

    Time frame: Directly prior to the CRT-implantation

    Results of blood gas analysis:

    Carbon dioxide partial pressure (pCO2) [mmHg]

  4. Carbon dioxide partial pressure (pCO2) [mmHg]

    Time frame: 6 months after CRT-implantation

    Results of blood gas analysis:

    Carbon dioxide partial pressure (pCO2) [mmHg]

  5. potential of hydrogen (pH) value [-]

    Time frame: Directly prior to the CRT-implantation

    Results of blood gas analysis:

    pH value [-]

  6. potential of hydrogen (pH) value [-]

    Time frame: 6 months after CRT-implantation

    Results of blood gas analysis:

    pH value [-]

  7. Base excess [mmol]

    Time frame: Directly prior to the CRT-implantation

    Results of blood gas analysis:

    Base excess [mmol]

  8. Base excess [mmol]

    Time frame: 6 months after CRT-implantation

    Results of blood gas analysis:

    Base excess [mmol]

  9. Lactate [mmol/l]

    Time frame: Directly prior to the CRT-implantation

    Results of blood gas analysis:

    Lactate [mmol/l]

  10. Lactate [mmol/l]

    Time frame: 6 months after CRT-implantation

    Results of blood gas analysis:

    Lactate [mmol/l]

  11. Glucose [mg/dl]

    Time frame: Directly prior to the CRT-implantation

    Results of blood gas analysis:

    Glucose [mg/dl]

  12. Glucose [mg/dl]

    Time frame: 6 months after CRT-implantation

    Results of blood gas analysis:

    Glucose [mg/dl]

  13. Electrolytes (K+, Na2+, Ca2+) [mmol/l]

    Time frame: Directly prior to the CRT-implantation

    Results of blood gas analysis:

    Electrolytes (K+, Na2+, Ca2+) [mmol/l]

  14. Electrolytes (K+, Na2+, Ca2+) [mmol/l]

    Time frame: 6 months after CRT-implantation

    Results of blood gas analysis:

    Electrolytes (K+, Na2+, Ca2+) [mmol/l]

  15. High-sensitive troponin T [µg/L]

    Time frame: Directly prior to the CRT-implantation

    Markers of myocardial ischemia and heart failure:

    High-sensitive troponin T [µg/L]

  16. High-sensitive troponin T [µg/L]

    Time frame: 6 months after CRT-implantation

    Markers of myocardial ischemia and heart failure:

    High-sensitive troponin T [µg/L]

  17. Total creatine kinase [µg/L]

    Time frame: Directly prior to the CRT-implantation

    Markers of myocardial ischemia and heart failure:

    Total creatine kinase [µg/L]

  18. Total creatine kinase [µg/L]

    Time frame: 6 months after CRT-implantation

    Markers of myocardial ischemia and heart failure:

    Total creatine kinase [µg/L]

  19. Creatinine kinase-myocardial band (CK-MB) [µg/L]

    Time frame: Directly prior to the CRT-implantation

    Markers of myocardial ischemia and heart failure:

    Creatinine kinase-myocardial band (CK-MB) [µg/L]

  20. Creatinine kinase-myocardial band (CK-MB) [µg/L]

    Time frame: 6 months after CRT-implantation

    Markers of myocardial ischemia and heart failure:

    Creatinine kinase-myocardial band (CK-MB) [µg/L]

  21. Aspartate aminotransferase [µg/L]

    Time frame: Directly prior to the CRT-implantation

    Markers of myocardial ischemia and heart failure:

    Aspartate aminotransferase [µg/L]

  22. Aspartate aminotransferase [µg/L]

    Time frame: 6 months after CRT-implantation

    Markers of myocardial ischemia and heart failure:

    Aspartate aminotransferase [µg/L]

  23. Lactate dehydrogenase [µg/L]

    Time frame: Directly prior to the CRT-implantation

    Markers of myocardial ischemia and heart failure:

    Lactate dehydrogenase [µg/L]

  24. Lactate dehydrogenase [µg/L]

    Time frame: 6 months after CRT-implantation

    Markers of myocardial ischemia and heart failure:

    Lactate dehydrogenase [µg/L]

  25. N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]

    Time frame: Directly prior to the CRT-implantation

    Markers of myocardial ischemia and heart failure:

    N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]

  26. N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]

    Time frame: 6 months after CRT-implantation

    Markers of myocardial ischemia and heart failure:

    N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]

  27. High-sensitive C-reactive protein (CRP) [µg/L]

    Time frame: Directly prior to the CRT-implantation

    Cytokines and inflammation markers:

    High-sensitive C-reactive protein (CRP) [µg/L]

  28. High-sensitive C-reactive protein (CRP) [µg/L]

    Time frame: 6 months after CRT-implantation

    Cytokines and inflammation markers:

    High-sensitive C-reactive protein (CRP) [µg/L]

  29. Procalcitonin (PCT) [µg/L]

    Time frame: Directly prior to the CRT-implantation

    Cytokines and inflammation markers:

    Procalcitonin (PCT) [µg/L]

  30. Procalcitonin (PCT) [µg/L]

    Time frame: 6 months after CRT-implantation

    Cytokines and inflammation markers:

    Procalcitonin (PCT) [µg/L]

  31. Interleukin 6 (IL-6) [µg/L]

    Time frame: Directly prior to the CRT-implantation

    Cytokines and inflammation markers:

    Interleukin 6 (IL-6) [µg/L]

  32. Interleukin 6 (IL-6) [µg/L]

    Time frame: 6 months after CRT-implantation

    Cytokines and inflammation markers:

    Interleukin 6 (IL-6) [µg/L]

Study contacts

Contact information is provided by the study sponsor or research team.

Ben Kappel, MD PhD

CONTACT

[email protected]

0241 800

Christina Kalvelage, M. Sc.

CONTACT

[email protected]

0241 80 36485

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Acronym: BIO-2-HEART

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Oct 26, 2017
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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