RecruitingNCT07309523

The Force Frequency Relationship in Heart Failure and Diabetes Mellitus: a Metabolic Aetiology?

The Force Frequency Relationship in Heart Failure: an Expression of a Metabolic Problem Driving Adverse Remodelling?


Sponsor

University of Leeds

Enrollment

160 participants

Start Date

Sep 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how the heart responds to different pacing rates in people with heart failure and diabetes, to better understand whether a metabolic problem (related to how the heart uses energy) is at the root of weakened heart contractions. It uses pacemaker technology to measure heart function at different heart rates. **You may be eligible if...** - You are over 18 years old - You have a medical reason to receive a pacemaker - You are mentally capable of giving informed consent **You may NOT be eligible if...** - You have significant anaemia (very low haemoglobin) - You have an active infection such as pneumonia - You have heart failure caused by sepsis (blood infection) - You are currently having a heart attack or severe chest pain (angina) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

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NCT07309523


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