The FFR and cardiac metabolism in HF and DM
Research type
Research Study
Full title
The force frequency relationship in heart failure: an expression of a metabolic problem driving adverse remodelling?
IRAS ID
341626
Contact name
Klaus Witte
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
61465, CPMS ID
Duration of Study in the UK
9 years, 11 months, 30 days
Research summary
In health, the heart's contraction power is closely linked to heart rate. Rises in heart rate are accompanied increases in contraction power to ensure increases in heart output during exercise. This response is weaker in people with heart failure and diabetes mellitus. Personalised solutions to this require an understanding of the cause. This study will explore the metabolism of the heart muscle cells, how it is different (or similar to skeletal muscle) and how it changes with different heart rates.
Patients listed for a rountine pacemaker implantation will be approached. They will be assessed carefully prior to the implant procedure with an exercise test, quality of life assessment, handgrip strength, heart scan, and non-invasive cardiac output assessment.
At the start of the pacemaker procedure we will take a small sample of fat and muscle tissue from the operation site and, as an optional substudy we will also perform a needle biopsy of the thigh muscle.
We will then place all of the pacemaker leads as usual. We will then place a small catheter into the artery of the lungs (pulmonary artery) and into the vein of the heart (coronary sinus). For many patients, this coronary sinus catheter will be part of the normal procedure, but for those people receiving only a normal pacemaker or implantable defibrillator, this will be an extra procedure.
Using the leads that we have implanted, we will pace the heart at different rates and pacing modes and take pressure measurements and blood samples from the vein of the heart to see how the heart muscle metabolism changes.
The rest of the procedure will be entirely normal.
Patients will be assessed using heart scans and exercise tests during routine pacemaker visits at 6 wks and 6 mths. We will follow particpants electronically for a maximum 10 yrs.
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
24/YH/0181
Date of REC Opinion
5 Sep 2024
REC opinion
Favourable Opinion