Heart failure Circulatory System
Conditions
Interventions
If the participant consents, a series of screening and baseline assessments will be conducted and recorded. These include capturing data from routine care on medical history, physical examinations, an
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Established diagnosis of non-ischemic (dilated) cardiomyopathy, who have been receiving guideline-directed standard of care (SoC) pharmacological treatment for at least 3 months. 2. Diagnosis according to ESC guidelines: left ventricular or biventricular systolic dysfunction and dilatation that are not explained by abnormal loading conditions or coronary artery disease. Specifically - Systolic dysfunction defined by abnormal LV ejection fraction, measured using any modality and shown either by two independent imaging modalities or on two distinct occasions by the same technique, preferably echocardiography or CMR. 3. Ability to adhere to study requirements including provision of consent to genetic testing 4. Aged > = 18 years
Exclusion criteria
Exclusion criteria: 1. Heart failure due to either congenital heart disease, hypertensive heart disease, primary valvular heart disease, active acute myocarditis, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy or a known correctable metabolic cause; 2. Active vasculitis 3. Known cognitive impairment or unable to provide consent. 4. Serious co-existing medical condition, including but not limited to known hepatic failure, known renal failure with known eGFR 45 kg/m²) 10. Known allergy to gadolinium contrast. 11. Known planned hospitalisations (e.g. elective surgery), or other scheduled treatment for pre-existing conditions during the course of the study that could interfere with clinical assessment. 12. Any known previous diagnosis of invasive cancer within the last 5 years except for treated basal cell carcinoma of the skin. 13. Known pre-existing severe liver disease, including chronic hepatitis or alcohol-dependent liver cirrhosis 14. Other medical or social reasons for exclusion at the discretion of the investigator 15. Hypersensitivity to materials included in the patch. 16. Treatment with an investigational drug or other intervention assessment of which has not completed the primary endpoint or that clinically interferes with the present study endpoints will be excluded from this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. CD3+CX3CR1+effector memory T-lymphocytes, measured by flow cytometry, at baseline and 6 months 2. Cardiac MRI parameters: T1 mapping, T2 mapping, ECV to assess inflammation and fibrosis. LV ejection fraction to assess left ventricular function and late gadolinium enhancement to assess for replacement fibrosis assessed at baseline 3. CMV seropositivity is measured by CMV IgG and IgM at baseline 4. Total T-cells and their main subsets (CD3, CD4 and CD8), Assessed by measured by the flow cytometry, at baseline and 6 months 5. Clonal CHIP mutation assessed at baseline with blood EDTA 6. Patch accelerometer to assess level of physical activity attached for up to 7 days at baseline and 6 months 7. Sit to stand test and the modified Borg scale to assess breathlessness at baseline and 6 months 8. KCCQ-23 score to assess quality of life at baseline and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed