NCT06774014 Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences
| NCT ID | NCT06774014 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Leeds |
| Condition | Diabetes Mellitus Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2030-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2025-02-26 with a primary completion date of 2030-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06774014 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetes Mellitus Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06774014 currently recruiting?
Yes, NCT06774014 is actively recruiting participants. Contact the research team at k.k.witte@leeds.ac.uk for enrollment information.
Where is the NCT06774014 trial being conducted?
This trial is being conducted at Leeds, United Kingdom.
Who is sponsoring the NCT06774014 clinical trial?
NCT06774014 is sponsored by University of Leeds. The trial plans to enroll 600 participants.
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