About this trial
The present investigation is a non-randomised, observational study involving an unselected but highly phenotyped cohort of patients undergoing pacemaker or defibrillator implantation from whom a small sample of fat and muscle will be taken from the operation site, and, in a subgroup, from the thigh muscle. A sample of blood wil also be taken from the vein of the heart, a peripheral vein and the artery at the wrist during the procedure at different heart rates and pacing modes, to describe how heart rate and heart contraction power relate to cardiac and peripheral metabolism.
The coded blood and tissue samples and anonymised clinical data will be stored in a Human Tissue Authority-approved freezer until analysis.
Following the procedure, during routine visits, patients' left ventricular force frequency relationship will be assessed using cardiac ultrasound and a non-invasive cardiac monitor to further phenotype the severity and progression of their heart function over 6 months. For most patients, their involvement will end at that point although they will be monitored through electronic health records on an annual basis from that point forward for up to 5 years after the end of the study (for up to ten years after that point) to gain information on the prognostic value of the metabolic and haemodynamic testing.
The present investigation will allow the investigators to advance the understanding of heart-muscle crosstalk with the goal of developing targeted interventions that could open new treatment avenues.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Guideline-compliant, clinical indication for pacemaker implantation
Age >18 years
Ability to provide written informed consent
Persons who are legally competent and mentally able to follow the instructions of the study staff
Disqualifiers
Anemia Hb <8 mg/dl
Patients with acute infectious diseases (e.g. pneumonia)
Patients with heart failure due to sepsis
People with acute myocardial ischemia, which is manifested, for example, by angina pectoris or ECG changes under stress
Trial population
People having an implantable cardiac device procedure
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Relationship between FFR and cardiac metabolomics
Is cardiac metabolism in patients with diabetes and diabetes with heart failure as assessed by mass spectrometry-based metabolomics and lipidomics abnormal at higher heart rates and is the degree of the impairment correlated with the heart rate at which peak contractility occurs?
Sponsors and contacts
Click on the lead sponsor to view all of their trials.