Heart FailureBIO-2-HEARTNCT03323216
BIO-2-HEART: Identification of Biomarkers in T2DM and Heart Failure
An observational study of Heart Failure and Diabetes Mellitus, Type 2, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diabetes Mellitus, Type 2
- What is being tested?
- 6-minute walk test, Study specific questionnaire and Blood collection
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with and without heart failure (HFrEF, HFmrEF, HFpEF) plus known status of type 2 diabetes (yes/no)
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Ben A Kappel, MD PhD
About this study
Official title: BIO-2-HEART Study (Identifying New BIOmarkers in Patients With Type 2 Diabetes Mellitus and HEArt Failure Receiving Cardiac Resynchronization Therapy Device Implantation)
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.
Read the detailed description
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.
- Conditions
- Heart Failure, Diabetes Mellitus, Type 2
- Being tested
- 6-minute walk test, Study specific questionnaire, Blood collection
- Medical subject headings
- Heart Failure, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk testDiagnostic 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 questionnaireDiagnostic test
Study specific questionnaire
The questionnaire is performed prior and 6 months after the intervention.
Blood collectionProcedure or surgery
Blood collection during surgery:
- coronary sinus
- arterial
- peripheral venous
Blood collection 6 months after surgery:
- peripheral venous
| Study group | Role | What they receive |
|---|---|---|
| No diabetes | Patients without diabetes Receives: Diagnostic Test: 6-minute walk test; Diagnostic Test: Study specific questionnaire; Procedure: Blood collection | |
| Type 2 diabetes | Patients with diagnosis of type 2 diabetes (new/established) Receives: Diagnostic Test: 6-minute walk test; Diagnostic Test: Study specific questionnaire; Procedure: Blood collection | |
| Prediabetes | Patients with an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold. Receives: Diagnostic Test: 6-minute walk test; Diagnostic Test: Study specific questionnaire; Procedure: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen partial pressure (pO2) [mmHg]
Results of blood gas analysis:
Oxygen partial pressure (pO2) [mmHg]
Measured: Directly prior to the CRT-implantation
Oxygen partial pressure (pO2) [mmHg]
Results of blood gas analysis:
Oxygen partial pressure (pO2) [mmHg]
Measured: 6 months after CRT-implantation
Carbon dioxide partial pressure (pCO2) [mmHg]
Results of blood gas analysis:
Carbon dioxide partial pressure (pCO2) [mmHg]
Measured: Directly prior to the CRT-implantation
Carbon dioxide partial pressure (pCO2) [mmHg]
Results of blood gas analysis:
Carbon dioxide partial pressure (pCO2) [mmHg]
Measured: 6 months after CRT-implantation
potential of hydrogen (pH) value [-]
Results of blood gas analysis:
pH value [-]
Measured: Directly prior to the CRT-implantation
potential of hydrogen (pH) value [-]
Results of blood gas analysis:
pH value [-]
Measured: 6 months after CRT-implantation
Base excess [mmol]
Results of blood gas analysis:
Base excess [mmol]
Measured: Directly prior to the CRT-implantation
Base excess [mmol]
Results of blood gas analysis:
Base excess [mmol]
Measured: 6 months after CRT-implantation
Lactate [mmol/l]
Results of blood gas analysis:
Lactate [mmol/l]
Measured: Directly prior to the CRT-implantation
Lactate [mmol/l]
Results of blood gas analysis:
Lactate [mmol/l]
Measured: 6 months after CRT-implantation
Glucose [mg/dl]
Results of blood gas analysis:
Glucose [mg/dl]
Measured: Directly prior to the CRT-implantation
Glucose [mg/dl]
Results of blood gas analysis:
Glucose [mg/dl]
Measured: 6 months after CRT-implantation
Electrolytes (K+, Na2+, Ca2+) [mmol/l]
Results of blood gas analysis:
Electrolytes (K+, Na2+, Ca2+) [mmol/l]
Measured: Directly prior to the CRT-implantation
Electrolytes (K+, Na2+, Ca2+) [mmol/l]
Results of blood gas analysis:
Electrolytes (K+, Na2+, Ca2+) [mmol/l]
Measured: 6 months after CRT-implantation
High-sensitive troponin T [µg/L]
Markers of myocardial ischemia and heart failure:
High-sensitive troponin T [µg/L]
Measured: Directly prior to the CRT-implantation
High-sensitive troponin T [µg/L]
Markers of myocardial ischemia and heart failure:
High-sensitive troponin T [µg/L]
Measured: 6 months after CRT-implantation
Total creatine kinase [µg/L]
Markers of myocardial ischemia and heart failure:
Total creatine kinase [µg/L]
Measured: Directly prior to the CRT-implantation
Total creatine kinase [µg/L]
Markers of myocardial ischemia and heart failure:
Total creatine kinase [µg/L]
Measured: 6 months after CRT-implantation
Creatinine kinase-myocardial band (CK-MB) [µg/L]
Markers of myocardial ischemia and heart failure:
Creatinine kinase-myocardial band (CK-MB) [µg/L]
Measured: Directly prior to the CRT-implantation
Creatinine kinase-myocardial band (CK-MB) [µg/L]
Markers of myocardial ischemia and heart failure:
Creatinine kinase-myocardial band (CK-MB) [µg/L]
Measured: 6 months after CRT-implantation
Aspartate aminotransferase [µg/L]
Markers of myocardial ischemia and heart failure:
Aspartate aminotransferase [µg/L]
Measured: Directly prior to the CRT-implantation
Aspartate aminotransferase [µg/L]
Markers of myocardial ischemia and heart failure:
Aspartate aminotransferase [µg/L]
Measured: 6 months after CRT-implantation
Lactate dehydrogenase [µg/L]
Markers of myocardial ischemia and heart failure:
Lactate dehydrogenase [µg/L]
Measured: Directly prior to the CRT-implantation
Lactate dehydrogenase [µg/L]
Markers of myocardial ischemia and heart failure:
Lactate dehydrogenase [µg/L]
Measured: 6 months after CRT-implantation
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]
Markers of myocardial ischemia and heart failure:
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]
Measured: Directly prior to the CRT-implantation
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]
Markers of myocardial ischemia and heart failure:
N-terminal pro-B-type natriuretic peptide (NT-proBNP) [µg/L]
Measured: 6 months after CRT-implantation
High-sensitive C-reactive protein (CRP) [µg/L]
Cytokines and inflammation markers:
High-sensitive C-reactive protein (CRP) [µg/L]
Measured: Directly prior to the CRT-implantation
High-sensitive C-reactive protein (CRP) [µg/L]
Cytokines and inflammation markers:
High-sensitive C-reactive protein (CRP) [µg/L]
Measured: 6 months after CRT-implantation
Procalcitonin (PCT) [µg/L]
Cytokines and inflammation markers:
Procalcitonin (PCT) [µg/L]
Measured: Directly prior to the CRT-implantation
Procalcitonin (PCT) [µg/L]
Cytokines and inflammation markers:
Procalcitonin (PCT) [µg/L]
Measured: 6 months after CRT-implantation
Interleukin 6 (IL-6) [µg/L]
Cytokines and inflammation markers:
Interleukin 6 (IL-6) [µg/L]
Measured: Directly prior to the CRT-implantation
Interleukin 6 (IL-6) [µg/L]
Cytokines and inflammation markers:
Interleukin 6 (IL-6) [µg/L]
Measured: 6 months after CRT-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start1 Apr 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben Kappel, RWTH Aachen University
- Investigators
- Ben Kappel, MD PhD, Principal investigator, Uniklinik RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323216
- Sponsor's protocol ID
- 16-132
- Acronym
- BIO-2-HEART
- Status last verified
- May 2024
- First submitted
- 26 Sep 2017
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
PubMed 27206819Askoxylakis V, Thieke C, Pleger ST, Most P, Tanner J, Lindel K, Katus HA, Debus J, Bischof M. Long-term survival of cancer patients compared to heart failure and stroke: a systematic review. BMC Cancer. 2010 Mar 22;10:105. doi: 10.1186/1471-2407-10-105.
PubMed 20307299Bahtiyar G, Gutterman D, Lebovitz H. Heart Failure: a Major Cardiovascular Complication of Diabetes Mellitus. Curr Diab Rep. 2016 Nov;16(11):116. doi: 10.1007/s11892-016-0809-4.
PubMed 27730517Kappel BA, Marx N, Federici M. Oral hypoglycemic agents and the heart failure conundrum: Lessons from and for outcome trials. Nutr Metab Cardiovasc Dis. 2015 Aug;25(8):697-705. doi: 10.1016/j.numecd.2015.06.006. Epub 2015 Jun 18.
PubMed 26164634Sun H, Guan Y, Wang L, Zhao Y, Lv H, Bi X, Wang H, Zhang X, Liu L, Wei M, Song H, Su G. Influence of diabetes on cardiac resynchronization therapy in heart failure patients: a meta-analysis. BMC Cardiovasc Disord. 2015 Mar 21;15:25. doi: 10.1186/s12872-015-0018-0.
PubMed 25880202Watson CJ, Ledwidge MT, Phelan D, Collier P, Byrne JC, Dunn MJ, McDonald KM, Baugh JA. Proteomic analysis of coronary sinus serum reveals leucine-rich alpha2-glycoprotein as a novel biomarker of ventricular dysfunction and heart failure. Circ Heart Fail. 2011 Mar;4(2):188-97. doi: 10.1161/CIRCHEARTFAILURE.110.952200. Epub 2011 Jan 31.
PubMed 21282491Truong QA, Januzzi JL, Szymonifka J, Thai WE, Wai B, Lavender Z, Sharma U, Sandoval RM, Grunau ZS, Basnet S, Babatunde A, Ajijola OA, Min JK, Singh JP. Coronary sinus biomarker sampling compared to peripheral venous blood for predicting outcomes in patients with severe heart failure undergoing cardiac resynchronization therapy: the BIOCRT study. Heart Rhythm. 2014 Dec;11(12):2167-75. doi: 10.1016/j.hrthm.2014.07.007. Epub 2014 Jul 8.
PubMed 25014756Costello-Boerrigter LC, Lapp H, Boerrigter G, Lerman A, Bufe A, Macheret F, Heublein DM, Larue C, Burnett JC Jr. Secretion of prohormone of B-type natriuretic peptide, proBNP1-108, is increased in heart failure. JACC Heart Fail. 2013 Jun;1(3):207-12. doi: 10.1016/j.jchf.2013.03.001. Epub 2013 Jun 3.
PubMed 24621871Marques FZ, Vizi D, Khammy O, Mariani JA, Kaye DM. The transcardiac gradient of cardio-microRNAs in the failing heart. Eur J Heart Fail. 2016 Aug;18(8):1000-8. doi: 10.1002/ejhf.517. Epub 2016 Apr 12.
PubMed 27072074Bergman BC, Tsvetkova T, Lowes B, Wolfel EE. Myocardial glucose and lactate metabolism during rest and atrial pacing in humans. J Physiol. 2009 May 1;587(Pt 9):2087-99. doi: 10.1113/jphysiol.2008.168286. Epub 2009 Mar 16.
PubMed 19289551
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIO-2-HEART Study (Identifying New BIOmarkers in Patients With Type 2 Diabetes Mellitus and HEArt Failure Receiving Cardiac Resynchronization Therapy Device Implantation)
- ClinicalTrials.gov ID
- NCT03323216
- Acronym / sponsor ID
- BIO-2-HEART / 16-132
- Conditions
- Heart Failure, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No diabetes | – | Diagnostic Test: 6-minute walk test, Diagnostic Test: Study specific questionnaire, Procedure: Blood collectionPatients without diabetes |
| Type 2 diabetes | – | Diagnostic Test: 6-minute walk test, Diagnostic Test: Study specific questionnaire, Procedure: Blood collectionPatients with diagnosis of type 2 diabetes (new/established) |
| Prediabetes | – | Diagnostic Test: 6-minute walk test, Diagnostic Test: Study specific questionnaire, Procedure: Blood collectionPatients with an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with and without heart failure (HFrEF, HFmrEF, HFpEF) plus known status of type 2 diabetes (yes/no)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walk 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. | Diagnostic test | No diabetes, Prediabetes, Type 2 diabetes |
| Study specific questionnaireStudy specific questionnaire The questionnaire is performed prior and 6 months after the intervention. | Diagnostic test | No diabetes, Prediabetes, Type 2 diabetes |
| Blood collectionBlood collection during surgery: * coronary sinus * arterial * peripheral venous Blood collection 6 months after surgery: - peripheral venous | Procedure or surgery | No diabetes, Prediabetes, Type 2 diabetes |
Primary outcome
Oxygen partial pressure (pO2) [mmHg]
Time frame: Directly prior to the CRT-implantation
Results of blood gas analysis: Oxygen partial pressure (pO2) [mmHg]
Oxygen partial pressure (pO2) [mmHg]
Time frame: 6 months after CRT-implantation
Results of blood gas analysis: Oxygen partial pressure (pO2) [mmHg]
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]
Carbon dioxide partial pressure (pCO2) [mmHg]
Time frame: 6 months after CRT-implantation
Results of blood gas analysis: Carbon dioxide partial pressure (pCO2) [mmHg]
potential of hydrogen (pH) value [-]
Time frame: Directly prior to the CRT-implantation
Results of blood gas analysis: pH value [-]
potential of hydrogen (pH) value [-]
Time frame: 6 months after CRT-implantation
Results of blood gas analysis: pH value [-]
Base excess [mmol]
Time frame: Directly prior to the CRT-implantation
Results of blood gas analysis: Base excess [mmol]
Base excess [mmol]
Time frame: 6 months after CRT-implantation
Results of blood gas analysis: Base excess [mmol]
Lactate [mmol/l]
Time frame: Directly prior to the CRT-implantation
Results of blood gas analysis: Lactate [mmol/l]
Lactate [mmol/l]
Time frame: 6 months after CRT-implantation
Results of blood gas analysis: Lactate [mmol/l]
Glucose [mg/dl]
Time frame: Directly prior to the CRT-implantation
Results of blood gas analysis: Glucose [mg/dl]
Glucose [mg/dl]
Time frame: 6 months after CRT-implantation
Results of blood gas analysis: Glucose [mg/dl]
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]
Electrolytes (K+, Na2+, Ca2+) [mmol/l]
Time frame: 6 months after CRT-implantation
Results of blood gas analysis: Electrolytes (K+, Na2+, Ca2+) [mmol/l]
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]
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]
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]
Total creatine kinase [µg/L]
Time frame: 6 months after CRT-implantation
Markers of myocardial ischemia and heart failure: Total creatine kinase [µg/L]
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]
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]
Aspartate aminotransferase [µg/L]
Time frame: Directly prior to the CRT-implantation
Markers of myocardial ischemia and heart failure: Aspartate aminotransferase [µg/L]
Aspartate aminotransferase [µg/L]
Time frame: 6 months after CRT-implantation
Markers of myocardial ischemia and heart failure: Aspartate aminotransferase [µg/L]
Lactate dehydrogenase [µg/L]
Time frame: Directly prior to the CRT-implantation
Markers of myocardial ischemia and heart failure: Lactate dehydrogenase [µg/L]
Lactate dehydrogenase [µg/L]
Time frame: 6 months after CRT-implantation
Markers of myocardial ischemia and heart failure: Lactate dehydrogenase [µg/L]
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]
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]
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]
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]
Procalcitonin (PCT) [µg/L]
Time frame: Directly prior to the CRT-implantation
Cytokines and inflammation markers: Procalcitonin (PCT) [µg/L]
Procalcitonin (PCT) [µg/L]
Time frame: 6 months after CRT-implantation
Cytokines and inflammation markers: Procalcitonin (PCT) [µg/L]
Interleukin 6 (IL-6) [µg/L]
Time frame: Directly prior to the CRT-implantation
Cytokines and inflammation markers: Interleukin 6 (IL-6) [µg/L]
Interleukin 6 (IL-6) [µg/L]
Time frame: 6 months after CRT-implantation
Cytokines and inflammation markers: Interleukin 6 (IL-6) [µg/L]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Background: PubMed 27206819Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.
- Background: PubMed 20307299Askoxylakis V, Thieke C, Pleger ST, Most P, Tanner J, Lindel K, Katus HA, Debus J, Bischof M. Long-term survival of cancer patients compared to heart failure and stroke: a systematic review. BMC Cancer. 2010 Mar 22;10:105. doi: 10.1186/1471-2407-10-105.
- Background: PubMed 27730517Bahtiyar G, Gutterman D, Lebovitz H. Heart Failure: a Major Cardiovascular Complication of Diabetes Mellitus. Curr Diab Rep. 2016 Nov;16(11):116. doi: 10.1007/s11892-016-0809-4.
- Background: PubMed 26164634Kappel BA, Marx N, Federici M. Oral hypoglycemic agents and the heart failure conundrum: Lessons from and for outcome trials. Nutr Metab Cardiovasc Dis. 2015 Aug;25(8):697-705. doi: 10.1016/j.numecd.2015.06.006. Epub 2015 Jun 18.
- Background: PubMed 25880202Sun H, Guan Y, Wang L, Zhao Y, Lv H, Bi X, Wang H, Zhang X, Liu L, Wei M, Song H, Su G. Influence of diabetes on cardiac resynchronization therapy in heart failure patients: a meta-analysis. BMC Cardiovasc Disord. 2015 Mar 21;15:25. doi: 10.1186/s12872-015-0018-0.
- Background: PubMed 21282491Watson CJ, Ledwidge MT, Phelan D, Collier P, Byrne JC, Dunn MJ, McDonald KM, Baugh JA. Proteomic analysis of coronary sinus serum reveals leucine-rich alpha2-glycoprotein as a novel biomarker of ventricular dysfunction and heart failure. Circ Heart Fail. 2011 Mar;4(2):188-97. doi: 10.1161/CIRCHEARTFAILURE.110.952200. Epub 2011 Jan 31.
- Background: PubMed 25014756Truong QA, Januzzi JL, Szymonifka J, Thai WE, Wai B, Lavender Z, Sharma U, Sandoval RM, Grunau ZS, Basnet S, Babatunde A, Ajijola OA, Min JK, Singh JP. Coronary sinus biomarker sampling compared to peripheral venous blood for predicting outcomes in patients with severe heart failure undergoing cardiac resynchronization therapy: the BIOCRT study. Heart Rhythm. 2014 Dec;11(12):2167-75. doi: 10.1016/j.hrthm.2014.07.007. Epub 2014 Jul 8.
- Background: PubMed 24621871Costello-Boerrigter LC, Lapp H, Boerrigter G, Lerman A, Bufe A, Macheret F, Heublein DM, Larue C, Burnett JC Jr. Secretion of prohormone of B-type natriuretic peptide, proBNP1-108, is increased in heart failure. JACC Heart Fail. 2013 Jun;1(3):207-12. doi: 10.1016/j.jchf.2013.03.001. Epub 2013 Jun 3.
- Background: PubMed 27072074Marques FZ, Vizi D, Khammy O, Mariani JA, Kaye DM. The transcardiac gradient of cardio-microRNAs in the failing heart. Eur J Heart Fail. 2016 Aug;18(8):1000-8. doi: 10.1002/ejhf.517. Epub 2016 Apr 12.
- Background: PubMed 19289551Bergman BC, Tsvetkova T, Lowes B, Wolfel EE. Myocardial glucose and lactate metabolism during rest and atrial pacing in humans. J Physiol. 2009 May 1;587(Pt 9):2087-99. doi: 10.1113/jphysiol.2008.168286. Epub 2009 Mar 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ben Kappel, MD PhD principal investigator
Uniklinik RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Diabetes Mellitus, Type 2, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ben Kappel, MD PhD (0241 800, bakppel@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen partial pressure (pO2) [mmHg] (time frame: Directly prior to the CRT-implantation). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03323216, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.