Exploring heart failure and diabetes interactions
Heart Failure in Patients With Diabetes: Cells, Crosstalk and Consequences
This study looks at how heart failure and diabetes affect the body differently by testing 600 people with various combinations of these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leeds Academic / other |
| Locations | 1 site (Leeds, West Yorkshire) |
| Trial ID | NCT06774014 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the differences in pathophysiology between individuals with and without heart failure, focusing on those with and without diabetes mellitus. It will involve 600 participants categorized into various groups based on their heart failure and diabetes status. Participants will undergo special heart scans, exercise testing, blood tests, and may provide samples of fat and muscle tissue for comprehensive analysis. The goal is to create a well-phenotyped cohort that allows for detailed comparisons of metabolic and proteomic interactions between tissues.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with varying conditions of heart failure and diabetes.
Not a fit: Patients with acute infectious diseases, severe COPD, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the interplay between heart failure and diabetes, leading to improved treatment strategies for affected patients.
How similar studies have performed: While there have been studies exploring heart failure and diabetes, this specific approach focusing on tissue cross-talk is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leeds, West Yorkshire
- Leeds Teaching Hospitals NHS Trust — Leeds, West Yorkshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Klaus Witte, MD
- Email: k.k.witte@leeds.ac.uk
- Phone: 007768254073
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.