Depression in patients with heart failure

Not Applicable

• Conditions: Adult patients with heart failure and cardiac implantable electronic devices (CIED); Circulatory System

• Registration Number: ISRCTN77516999
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-07
• Last Update Posted: 5 February 2024
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 50

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured at a single time point:<br>1. Beck Depression Inventory II (BDI-II) to asses mood.<br>2. The Quick Inventory of Depressive Symptomatology - Self-report (QIDS-SR) to assess mood.<br>3. Structured interview, informed by the Mini-International Neuropsychiatric Interview (MINI), to obtain descriptive data about mood.

Secondary Outcome Measures

Name	Time	Method
Measured at a single time point:<br>1. 5-level EuroQol 5D version (EQ-5D-5L) scale for quality of life.<br>2. 21-item Minnesota Living with Heart Failure (MLHF) questionnaire for quality of life in people with heart failure.<br>3. Multi-dimension Fatigue Inventory (MFI) to assess fatigue.<br>4. Composite Autonomic Symptom Scale-31 (COMPASS-31) to assess symptoms of autonomic function.<br>5. THINC-it cognitive screening tool for cognition.<br>6. Blood sample to test for N- terminal pro-brain natriuretic peptide (NT-proBNP) level, to estimate heart function.<br>7. Heart rate data will be downloaded from participants’ cardiac implantable electronic device. <br>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.