Actively Recruiting
Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences
Led by University of Leeds · Updated on 2025-02-28
600
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring differences in heart function and metabolism in people with and without heart failure (both reduced and preserved ejection fraction) and with and without type 2 diabetes. The study focuses on how fat, muscle, blood vessels, and the heart interact. This observational study aims to better understand how diabetes and heart failure work together at a cellular level to affect health, which could help guide future treatments. The study is conducted by the University of Leeds and involves a detailed examination of various patient groups. Participants are divided into six groups based on their heart failure and diabetes status: those with reduced ejection fraction heart failure with or without diabetes, those with preserved ejection fraction heart failure with or without diabetes, people with diabetes only, and healthy controls without either condition. The study includes heart ultrasounds, exercise tests, lung and muscle strength assessments, blood tests, glucose monitoring, and in some cases tissue samples and MRI scans. Data collection is comprehensive, including metabolomics and cell studies. Participants will undergo detailed testing at the start, including scans, blood sampling, and physical assessments. After initial testing, they will be followed annually through their medical records for up to ten years to track health outcomes. The study measures long-term effects and aims to link cellular and metabolic findings with clinical results. Tissue and blood samples will be stored and analyzed to identify how diabetes affects heart failure progression, supporting the development of targeted therapies.
CONDITIONS
Brief Title
Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >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...
- Anaemia Hb <8 mg/dl
- Patients with acute infectious diseases (e.g. pneumonia)
- Patients with heart failure due to sepsis
- People with acute myocardial ischemia, such as angina or ECG changes under stress
- Patients with acute liver or kidney failure or severe COPD (FEV1 <1.0)
- Pregnant and breastfeeding women
- People who are institutionalized on official or court orders
- People who are dependent or employed by the sponsor or investigator
- Taking investigational study medication within 30 days before the study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment period
Participants undergo detailed assessments including cardiac ultrasound, exercise testing, lung function, non-invasive haemodynamics, autonomic function, muscle strength testing, blood testing, longer term glucose monitoring, blood sampling, and some provide tissue samples. A subgroup will have an MRI scan of the heart and thigh muscles.
1 to 2 visits depending on subgroup assignment
Duration - Up to 10 years
Participants' health is monitored using their digital records on an annual basis for up to 10 years to gather prognostic information related to metabolic and haemodynamic testing results.
Annual remote monitoring with no in-person visits required
Trial Site Locations
Total: 1 location
1
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS16 5AR
Actively Recruiting
Research Team
K
Klaus Witte, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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