Diabetes mellitus and heart failure Circulatory System
Conditions
Interventions
Each person will undergo the following assessments, the results of which will be recorded on a bespoke eForm that sits within the Leeds Patient Pathway Manager electronic patient record system:
1) De
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Ability to provide written informed consent 3. Persons who are legally competent and mentally able to follow the instructions of the study staff
Exclusion criteria
Exclusion criteria: 1. Anemia Hb <8 mg/dl 2. Acute infectious diseases (e.g. pneumonia) 3. Heart failure due to sepsis 4. Acute myocardial ischemia, which is manifested, for example, by angina pectoris or ECG changes under stress 5. Acute liver or kidney failure or severe COPD (FEV1<1.0) 6. Pregnant and breastfeeding women 7. People who are institutionalized on official or court orders 8. People who are dependent or employed by the sponsor or investigator 10. Taking study medication (of an investigational drug) 30 days before the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeletal muscle cellular metabolism measured using mass spectrometry-based metabolomics and lipidomics on skeletal muscle and fat biopsies, between two phenotypes of heart failure and controls, and in patients with diabetes mellitus at a single timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Relationship of clinical outcomes (all-cause hospitalisation and mortality measured using the Leeds Patient Pathway Manager electronic patient record system to intercellular communication (within and across organ beds) between two phenotypes of heart failure and controls, and in patients with diabetes mellitus at a single time point 2. Relationship of patient symptoms [NYHA class], diuretic dose [normalised furosemide dose], quality of life [as assessed by the Kansas City Cardiomyopathy Questionnaire and the EuroQoL EQ5D-5L] and exercise capacity [as measured by cardiopulmonary exercise testing] to intercellular communication (within and across organ beds) between two phenotypes of heart failure and controls, and in patients with diabetes mellitus at a single time point 3. The effect of 'cross-talk' on the functions of skeletal muscle, fat, platelets and clotting function, and cardiac function measured using metabolomics, lipidomics, studies of coagulation at a single time point 4. Autonomic function measured using muscle sympathetic nerve activity (MSNA) and heart rate variability between two phenotypes of heart failure and controls, and in patients with diabetes mellitus at a single time point 5. Lung function, including inspiratory, expiratory and bronchiolar resistance measured using impulse oscillometry and spirometry between two phenotypes of heart failure and controls, and in patients with diabetes mellitus at a single time point 6. Cardiac contractility and peripheral vascular function measured using cardiac magnetic resonance and non-invasive haemodynamics between two phenotypes of heart failure and controls, and in patients with diabetes mellitus at a single time point | — |
Countries
England, United Kingdom
Contacts
Public ContactKlaus Witte
Outcome results
None listed