Heart Failure in Diabetes: cells, crosstalk and consequences
Research type
Research Study
Full title
Heart failure in Patients with Diabetes: cells, crosstalk and consequences
IRAS ID
343489
Contact name
Klaus Witte
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
62251, CPMS ID
Duration of Study in the UK
4 years, 11 months, 31 days
Research summary
Heart failure and diabetes mellitus are common life-limiting illnesses that frequently occur together, each worsening the other in a synergistic relationship that leads to greater symptoms, resistance to therapies and shorter longevity.
We want to find out how these conditions interact at a clinical, cellular and metabolic level thereby beginning the process of determining possible targets for personalised therapy.
The project will enrol 600 people over 3-5 years. Of these, we plan to enrol 400 with heart failure (of whom 200 will have heart failure with impaired heart function and 200 with preserved pumping function). Of these, we will aim for 100 in each of the two cohorts to ALSO have diabetes mellitus. We will also enrol 100 people with diabetes mellitus but no heart failure and up to 100 people with neither.
Participants will undergo tests of system functioning (exercise testing, symptom and quality of life assessment, measures of frailty and autnomic function), organ function (heart, blood, fat tissue, kidneys, lungs and muscles) and, through targeted biopsies, cellular function. Moreover, this study will allow us to determine how these organs and cells communicate with each other.
People will be enrolled from clinics at the Leeds Teaching Hospitals Trust (LTHT).
Those with neither condition will be approached at clinics (for example family members and carers of patients) or self volunteer through posters. All tests will be carried out at the Leeds Clinical Research Facility. Clinical data will be stored on the bespoke database held at LTHT.
Biological samples will be coded, securely transferred to the University of Leeds where they will be stored. Following analysis, laboratory results will be linked back to the clinical variables.
Participants will be followed for 5yrs after the end of the recruitment phase (which will last 5 years) such that some will be followed-up for 10 years.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0227
Date of REC Opinion
17 Dec 2024
REC opinion
Further Information Favourable Opinion