Depression in patients with heart failure
| ISRCTN | ISRCTN77516999 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77516999 |
| IRAS number | 312832 |
| Secondary identifying numbers | IRAS 312832 |
- Submission date
- 04/09/2022
- Registration date
- 07/03/2023
- Last edited
- 23/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Many people in the North East and North Cumbria in England (UK) have heart failure, some of whom will also suffer with depression. Having both conditions is particularly challenging. It means you are more likely to have a worse quality of life, feel more fatigued and more likely to need hospital treatment for your heart failure. It also increases the chances of poor outcomes, such as heart transplant or death. It is much harder to diagnose depression in people with heart failure, so you may be less likely to access specialist mental health support. Also, the usual treatments for depression (talking therapies and medication) do not appear to be helpful in patients with heart failure.
The autonomic nervous system controls the unconscious activity in our body. It has an important role in regulating heart rate. Normally there is variation to the heart rate: sometimes the heart beats a little faster and sometimes a little slower. We call this ‘heart rate variability’ and it is a sign of a healthy heart. Heart rate variability is often reduced in heart failure and in depression. Therefore, we wonder if dysregulation of the autonomic nervous system is an important link between heart disease and mood, leading to worse outcomes.
Who can participate?
Adults over 18 years, with heart failure.
What does the study involve?
We want to learn more about depression in people with heart failure. 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 heart monitors. They allow us to measure their heart rates, and we will use these data to study heart rate variability – this will be an indicator of autonomic nervous system function. A single blood test will be taken to understand how well the heart is functioning, so that we can correlate heart disease severity with our findings.
What are the possible benefits and risks of participating?
Participants will not have any direct benefit from participating in our study. However, the results of our study might one day help improve the way we identify and treat depression in people with heart failure. We hope that this will help patients and families in this situation to improve their quality of life. If you choose to participate, you will be a fundamental part of making things better.
Apart from asking participants some questions and taking a blood test, we are not doing anything to them that wouldn’t normally happen. Because of this, we are not expecting any side-effects to develop. As a result of getting a blood sample collected, participants might experience pain, bruising, light-headedness and on rare occasions, infection. We will help them get assistance if that happens. The usual NHS indemnity scheme will apply to all activities of this study.
We will talk about sensitive topics such a low mood and depression. The person who will interview the participants is a psychiatrist, a medical doctor who is specially trained to do this. We will do our very best to be sensitive in our approach. Participants might still find it distressing and will offer help if that is the case. If we do find that participants have depression and if they feel that they don’t have enough help for this, we can help them get in touch with their GP. We will not give them any treatment for depression as part of the study, but we can tell them how to get help.
There will be no changes to the heart failure treatment as a part of this study. If participants feel that they need any extra help, we can help them speak to the doctors and nurses at Newcastle Hospitals who look after their hearts.
Where is the study run from?
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2020 to June 2025
Who is funding the study?
Newcastle upon Tyne Hospitals Charity and Join Research Executive Scientific Committee Research Grant (UK)
Who is the main contact?
Dr Alan Bagnall, alan.bagnall@nhs.net
Contact information
Principal Investigator
Cardiology Department
Freeman Hospital
Freeman Road
High Heaton
Newcastle Upon Tyne
NE7 7DN
United Kingdom
 ORCID ID |
0000-0003-0683-851X |
|---|---|
| Phone | +44 1912137135 |
| alan.bagnall@nhs.net |
Study information
| Study design | Observational cross-sectional |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | 42324 PIS_V5.0_DRAFT 02.12.2022.pdf |
| Scientific title | Quality of life, fatigue and autonomic dysfunction in patients with heart failure: association with symptoms of low mood and depression. |
| Study hypothesis | Autonomic nervous system (ANS) dysregulation may underpin the link between depression, fatigue and poor quality of life in comorbid heart failure (HF). This would help explain why so many people with heart failure also have depression, why it has such an impact on their quality of life and why depression in heart failure patients is so difficult to treat. |
| Ethics approval(s) | Approved 20/11/2022, Newcastle North Tyneside 1 Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 2071048255; newcastlenorthtyneside1.rec@hra.nhs.uk), ref: 22/NE/0209. |
| Condition | Adult patients with heart failure and cardiac implantable electronic devices (CIED) |
| Intervention | 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 heart monitors. They allow us to measure their heart rates, and we will use these data to study heart rate variability – this will be an indicator of autonomic nervous system function. A single blood test will be taken to understand how well the heart is functioning, so that we can correlate heart disease severity with our findings. |
| Intervention type | Other |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 22/02/2020 |
| Overall study end date | 30/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Participant 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. |
| Participant 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. |
| Recruitment start date | 01/02/2023 |
| Recruitment end date | 31/01/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor information
Hospital/treatment centre
Cardiology Department
Freeman Hospital Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
United Kingdom
| Phone | +44 1912137135 |
|---|---|
| nuth.nuthsponsorship@nhs.net | |
| Website | https://www.newcastle-hospitals.nhs.uk |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Our project focus on mental health and quality of life with a ‘real world’ design. Our findings will reflect the concrete challenges faced regionally by patients and their carers. This will allow us to have impact in different domains: • Clinical: Provide evidence on the validity of simple tools (self-reported questionnaires) to identify patients at higher risk of worse outcomes. This is likely to make the identification of higher risk patients easier and more cost-effective. • Service / commissioning: Potentially open a pathway for the development of targeted interventions for low mood and fatigue (e.g. antidepressants, exercise), or treatments that directly target autonomic dysfunction. • Patients: Participants in this exploratory study will be given the opportunity to be involved in the design of future larger studies in the same theme, by becoming members of an advisory group. • Public: We are involved in the development of the Northern Mental Health webpage (www.northernmentalhealth.org). Public involvement thus far suggests there is a lack of awareness to the effects of depression comorbidity in people suffering with heart conditions. One of the deliverables from this project will be the development of themed materials for the website, targeting the general public. • Academic: Expand the understanding of the relationship between the different symptom clusters in patients with HF and depression, including the mediating role of the autonomic nervous system. • Future research: This project was designed as an exploratory study, intended to generate data and hypothesis to allow us to apply for national peer reviewed funding opportunities. |
| IPD sharing plan | All data will be stored for up to 5 years after the last data is collected. Data will be available to other researchers on reasonable request, made to the study PI (Dr Alan Bagnall) via email (alan.bagnall@nhs.net). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 5.0 | 02/12/2022 | 22/12/2022 | No | Yes |
| Protocol file | version 7.0 | 02/12/2022 | 22/12/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
23/01/2024: The following changes were made:
1. The overall study end date was changed from 30/09/2023 to 30/06/2025.
2. The recruitment end date was changed from 31/01/2024 to 31/01/2025.
3. The intention to publish date was changed from 30/09/2024 to 31/01/2026.
22/12/2022: Trial's existence confirmed by NHS HRA.
