Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07309523

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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