Actively Recruiting
The Force Frequency Relationship in Heart Failure and Diabetes Mellitus: a Metabolic Aetiology?
Led by University of Leeds · Updated on 2026-01-05
160
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Force Frequency Relationship in Heart Failure and Diabetes Mellitus: a Metabolic Aetiology?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Guideline-compliant, clinical indication for pacemaker implantation
- Age over 18 years
- Ability to provide written informed consent
- Persons who are legally competent and mentally able to follow the instructions of the study staff
You will not qualify if you...
- Anemia with hemoglobin below 8 mg/dl
- Acute infectious diseases such as pneumonia
- Heart failure caused by sepsis
- Acute myocardial ischemia demonstrated by angina or ECG changes under stress
- Acute liver or kidney failure
- Pregnant or breastfeeding women
- People institutionalized by official or court orders
- People dependent on or employed by the sponsor or investigator
- Use of investigational drug within 30 days before study start
- Known allergy to contrast dye or estimated glomerular filtration rate below 20 ml/min/1.73m2
- Pregnancy not excluded by bedside pregnancy test in premenopausal women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Actively Recruiting
Research Team
K
Klaus K Witte, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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