A study to link IMMUNE biology with the features of patients with the heart condition dilated cardiomyopathy
- Conditions
- Heart failureCirculatory System
- Registration Number
- ISRCTN17189947
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 100
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
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 < 30 mL/min/1.73m², or severe psychiatric disorder, known at the time of inclusion.
5. Cardiogenic shock, non-compensated acute heart failure and/or pulmonary oedema.
6. Cardiac resynchronization pacemaker implantation within previous 3 months.
7. Active infection at the time of enrolment.
8. History of established coronary disease with known epicardial stenosis of more than 70%
9. Patients unable to tolerate or undergo MRI scanning including patients with claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants unless approved for use in MRI scanners or excessive body weight (BMI> 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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. CD3+CX3CR1+effector memory T-lymphocytes, measured by flow cytometry, at baseline and 6 months<br>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<br>3. CMV seropositivity is measured by CMV IgG and IgM at baseline<br>4. Total T-cells and their main subsets (CD3, CD4 and CD8), Assessed by measured by the flow cytometry, at baseline and 6 months<br>5. Clonal CHIP mutation assessed at baseline with blood EDTA<br>6. Patch accelerometer to assess level of physical activity attached for up to 7 days at baseline and 6 months<br>7. Sit to stand test and the modified Borg scale to assess breathlessness at baseline and 6 months<br>8. KCCQ-23 score to assess quality of life at baseline and 6 months.
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures