Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences
Recruiting · NCT06774014 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Leeds
View the official record on ClinicalTrials.gov →What this trial is about
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. 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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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, 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)
- 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 study medication (of an investigational drug) 30 days before the start of the study
Where it is running
2 locations listed.
- Leeds Teaching Hospitals NHS Trust - Leeds, West Yorkshire, United Kingdom
- Leeds Teaching Hospitals NHS Trust - Leeds, West Yorkshire, United Kingdom