Studying heart failure and diabetes to compare how the body's tissues interact
Compares heart and metabolic tests in adults with heart failure, diabetes, or neither.
Key facts
- Who runs it
- University of Leeds
- Where
- Leeds, United KingdomSee the site
- Trial code
- Registry title
- Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences
- Status
- Recruiting
- People taking part
- 600 people, planned
- Started
- 26 Feb 2025
- Expected to end
- 31 Jan 2030
- Type of study
- Observational, 6 groups
- Record updated
- 28 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with or without heart failure and with or without type 2 diabetes. It compares these groups with scans, exercise and blood tests.
- Age
- Over 18 years
- Sex
- All sexes
- Disease stage
- Groups with heart failure (reduced or preserved ejection fraction) and/or diabetes, plus a group with neither.
- Earlier treatment
- People who took an investigational drug in the 30 days before the start cannot join.
Main reasons for not taking part
- Anaemia (Hb <8 mg/dl)
- Acute infectious disease such as pneumonia
- Heart failure due to sepsis
- Acute heart ischemia, for example angina or ECG changes under stress
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Taking study medication (of an investigational drug) 30 days before the start of the study
- Patients with acute infectious diseases (e.g. pneumonia)
- Patients with heart failure due to sepsis
- People with acute myocardial ischemia, which is manifested, for example, by angina pectoris or ECG changes under stress
- Patients with acute liver or kidney failure or severe COPD (FEV1<1.0)
- Anaemia Hb <8 mg/dl
- Pregnant and breastfeeding women
- People who are institutionalized on official or court orders
- People who are dependent or employed by the sponsor or investigator
Where in United Kingdom
- Leeds Teaching Hospitals NHS TrustLeeds, United KingdomContact: Klaus WitteTaking people
About the trial
What the trial wants to find out
This will be an observational study to explore differences in pathophysiology between groups of people with and without heart failure (HF) (reduced and preserved ejection fraction) and with and without diabetes mellitus (DM) with a particular focus on cross-talk (fat, muscle, vascular tissue and the heart). The investigators will invite 600 people to partcipate (100 with HFrEF+DM, 100 with HFpEF+DM, 100 with HFpEF-DM, 100 with HFrEF-DM, 100 with DM, 100 without either HR or DM). Special heart scans, exercise testing, blood testing, testing of the automatic nervous system will be performed and in some, samples of fat and muscle and endothelial cells will be collected.
Read full original descriptionShow less
These data will be used to create a cohort of well phenotyped patients with a variety of comprehensively collected clinical information, a cell atlas, and a comprehensive assessment of metabolomics, proeomics and cross-talk in between tissues, allowing comparisons between each group.
The 6 groups in the trial
- HFrEF-DM
People with heart failure due to reduced ejection fraction without diabetes mellitus
- HFrEF+DM
People with heart failure due to reduced ejection fraction who also have diabetes mellitus
- HFpEF-DM
People with heart failure with preserved ejection fraction without diabetes mellitus
- HFpEF+DM
People with heart failure with preserved ejection fraction who also have diabetes mellitus
- DM
People who have diabetes mellitus but do not have heart failure
- Control
People who have neither heart failure nor diabetes mellitus
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences
- Plain-language title
- Studying heart failure and diabetes to compare how the body's tissues interactGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 28 February 2025