Depression in patients with heart failure
| ISRCTN | ISRCTN77516999 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77516999 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 312832 |
| Protocol serial number | IRAS 312832 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funder | Newcastle upon Tyne Hospitals Charity and Join Research Executive Scientific Committee Research Grant |
- Submission date
- 04/09/2022
- Registration date
- 07/03/2023
- Last edited
- 18/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
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 2026
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
| Primary study design | Observational |
|---|---|
| Study design | Observational cross-sectional |
| Secondary study design | Cross sectional study |
| 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 objectives | 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. |
| Health condition(s) or problem(s) studied | 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(s) |
Measured at a single time point: |
| Key secondary outcome measure(s) |
Measured at a single time point: |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/02/2023 |
| Date of final enrolment | 31/01/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version 5.0 | 02/12/2022 | 22/12/2022 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 7.0 | 02/12/2022 | 22/12/2022 | No | No |
Additional files
- 42324 protocol_v7.0_DRAFT_02Dec2022.pdf
- Protocol file
- 42324 PIS_V5.0_DRAFT 02.12.2022.pdf
- Participant information sheet
Editorial Notes
18/06/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2025 to 31/01/2026.
2. The overall end date was changed from 30/06/2025 to 30/06/2026.
3. The plain English summary was updated to reflect these changes.
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.
