Adult patients with heart failure and cardiac implantable electronic devices (CIED) Circulatory System
Conditions
Interventions
We will interview people with heart failure and collect information about their mood, fatigue, quality of life and autonomic nervous system function. Many people with heart failure have implanted hear
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. = 18 years of age. 2. Open to the heart failure clinics at the Freeman Hospital or Royal Victoria Infirmary (RVI), NuTH. 3. Diagnosis of heart failure with reduced ejection fraction (HFrEF) - severe left ventricle systolic dysfunction (LVSD) with ejection fraction (EF) < 35%. 4. Cardiac implantable electronic device (CIED) in place. 5. Able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous diagnosis of bipolar affective disorder, psychotic disorder or personality disorder. 2. Previous diagnosis of dementia. 3. Previous diagnosis of primary neurological injury (eg, anoxic injury, stroke or traumatic brain injury) or disorder (eg, Parkinson’s disease). 4. Myocardial infarction (MI) within the previous 3 months. 5. Not fluent in English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at a single time point: 1. Beck Depression Inventory II (BDI-II) to asses mood. 2. The Quick Inventory of Depressive Symptomatology - Self-report (QIDS-SR) to assess mood. 3. Structured interview, informed by the Mini-International Neuropsychiatric Interview (MINI), to obtain descriptive data about mood. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at a single time point: 1. 5-level EuroQol 5D version (EQ-5D-5L) scale for quality of life. 2. 21-item Minnesota Living with Heart Failure (MLHF) questionnaire for quality of life in people with heart failure. 3. Multi-dimension Fatigue Inventory (MFI) to assess fatigue. 4. Composite Autonomic Symptom Scale-31 (COMPASS-31) to assess symptoms of autonomic function. 5. THINC-it cognitive screening tool for cognition. 6. Blood sample to test for N- terminal pro-brain natriuretic peptide (NT-proBNP) level, to estimate heart function. 7. Heart rate data will be downloaded from participants’ cardiac implantable electronic device. 8. Information from patients’ clinical records: Data will collected on: Demographics, including age, sex, gender identity, sexuality, ethnicity, marital status and occupation; Previous physical health and mental health diagnosis; Current medication and medication taken over the previous year, including doses. | — |
Countries
England, United Kingdom
Outcome results
None listed