How heart rate and metabolism relate in heart failure and diabetes
Studies blood and tissue samples from adults having a pacemaker or defibrillator fitted.
Plain-language title generated from the registry record
Registry title: The Force Frequency Relationship in Heart Failure and Diabetes Mellitus: a Metabolic Aetiology?
Key facts
- Where
- Leeds, United KingdomSee the site
Where in United Kingdom
- Leeds Teaching Hospitals NHS TrustLeeds, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Leeds
- Trial code
- NCT07309523
- Record updated
- 5 January 2026
- Original description
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.Read full original descriptionShow less
The Force Frequency Relationship in Heart Failure: an Expression of a Metabolic Problem Driving Adverse Remodelling?
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.
Inclusion: 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.
Exclusion: Taking study medication (of an investigational drug) 30 days before the start of the study; 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; Patients with acute liver or kidney failure; Anemia Hb <8 mg/dl; Known contrast allergy or eGFR <20ml/min/1.73m2; Pregnant and breastfeeding women; People who are institutionalized on official or court orders; People who are dependent or employed by the sponsor or investigator; Pregnancy not excluded by bedside pregnancy test in premenopausal women.