Measuring levels of inflammation in patients with heart failure and how they relate to heart function and quality of life
| ISRCTN | ISRCTN15573532 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15573532 |
| IRAS number | 304359 |
| Secondary identifying numbers | 2-012-22, IRAS 304359, CPMS 51422 |
- Submission date
- 13/07/2022
- Registration date
- 15/07/2022
- Last edited
- 25/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Although medical advances have led to improvements in treatments for some types of heart failure, there are still many things we can improve to help patients live longer, prevent hospital admissions, and improve quality of life. Previous studies have suggested that high levels of inflammation might either cause HF or lead to worse symptoms in patients with HF. Levels of inflammation in the bloodstream are regulated by a number of different substances. One of these is a group of substances called salt-inducible kinases (SIKs). In this study, we are going to find out whether levels of SIK activity are related to heart muscle structure and function and symptoms of HF.
If we can understand relationship between SIK activity and inflammation in HF, we could potentially develop new, much needed treatments to improve patients’ lives.
We plan to recruit 100 HF patients. We will collect detailed clinical information and blood samples from patients who have consented to participate. This type of study is particularly important as we plan to study a variety of patients with HF, rather than limiting to certain groups, to get a “real-world” picture of how heart failure affects patients.
Who can participate?
Patients with a diagnosis of heart failure.
What does the study involve?
• A blood sample (of approximately 50mls, or 5 tablespoons).
• A heart scan (echocardiogram, an ultrasound test).
• A questionnaire about how your life is impacted by heart failure.
• Allow us to record your past medical history and blood results.
• Allow us to follow up your clinical care by review of relevant medical records.
These tests will be performed at the first visit. For in-patients, we will perform 2 blood tests one within 48 hours of your admission and one at 5 days (or prior to discharge if you are discharged before 5 days). Out-patients will have one sample.
40 patients will be recalled for another blood test at 6 months depending on the level of inflammation on the first blood test.
What are the possible benefits and risks of participating?
Benefits: We already know that heart failure is a major public health issue worldwide. There may not be any direct benefits to you immediately from taking part in the study, however the information we obtain will be useful for us to understand the problems patients with heart failure have. In future we any study findings we make might be useful in understanding why heart failure develops and in developing new treatments for heart failure. These results will be of interest to those involved in providing healthcare and may influence the way we use existing treatments and the advice we give. If we do identify something that may impact on your clinical care we will tell you and your clinician immediately. We will also cover reasonable travel expenses. If you are interested we will send you a summary of the full study results by email or post – please let us know at any point.
Risks: The standard technique for taking blood would be used and if you have given blood before, you will know that you may experience some brief discomfort and/or bruising at the site. You may well also have had an echo scan before. It can sometimes be a little uncomfortable as we occasionally need to press on your chest with the probe to get good pictures, but generally, patients also manage this without any problems.
Where is the study run from?
Ninewells Hospital, Dundee (UK)
When is the study starting and how long is it expected to run for?
April 2022 to December 2023
Who is funding the study?
Tenovus Scotland (UK)
Who is the main contact?
Dr Ify Mordi, i.mordi@dundee.ac.uk
Contact information
Principal Investigator
Molecular and Clinical Medicine
University of Dundee
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
 ORCID ID |
0000-0002-2686-729X |
|---|---|
| Phone | +44 1382383106 |
| i.mordi@dundee.ac.uk |
Study information
| Study design | Single-centre observational cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | 42061 PIS V1 13Apr2022.pdf |
| Scientific title | Inflammation and Salt-inducible kinases - a potential novel therapeutic strategy in patients with heart failure |
| Study acronym | SIK-HF |
| Study objectives | 1. To determine whether levels of systemic inflammation and SIK activity are related to cardiac structural, functional parameters, and quality of life in patients with heart failure. Hypothesis: Higher levels of systemic inflammation are associated with greater severity of HF, judged by more cardiac structural and functional abnormalities and worse quality of life than those with lower levels of inflammation. 2. To assess, in an ex-vivo study in patients with HF, whether SIK inhibition is associated with a reduction in inflammation, potentially supporting this as a novel therapeutic strategy in patients with HF. Hypothesis: SIK inhibition is associated with a reduction in markers of inflammation in HF patients. |
| Ethics approval(s) | Approved 27/06/2022, East of Scotland Research Ethics Service (Tayside medical science centre, Residency Block Level 3, George Pirie Way, Ninewells Hospital and Medical School, Dundee, DD1 9SY, UK; +44 1382 383871; tay.eosres@nhs.scot), ref: 22/ES/0019 |
| Health condition(s) or problem(s) studied | Heart failure |
| Intervention | Blood samples, echocardiography and a quality of life questionnaire will be performed in all patients at baseline. Hospitalised patients will have blood sampling performed at 5 days (or on the day of discharge if earlier). A subset of patients will be recalled for further blood sampling, questionnaire and echocardiography at 6 months. |
| Intervention type | Other |
| Primary outcome measure | Level of SIK activity measured by blood test at baseline |
| Secondary outcome measures | At baseline: 1. Other blood markers of inflammation (interleukins 1-beta, 6 and 10, C-reactive protein) 2. Quality of life measured by the Kansas City Cardiomyopathy Questionnaire 3. Left ventricular ejection fraction measured by echocardiography |
| Overall study start date | 01/04/2022 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 77 |
| Key inclusion criteria | 1. Adults (>18 years) 2. Diagnosis of heart failure (stage B or stage C) 3. Able to give informed consent |
| Key exclusion criteria | Unable or unwilling to give consent |
| Date of first enrolment | 20/07/2022 |
| Date of final enrolment | 31/08/2023 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Dundee
DD1 9SY
United Kingdom
Sponsor information
University/education
Research Governance
Tayside Medical Science Centre (TASC)
Ninewells Hospital & Medical School
Dundee
DD1 9SY
Scotland
United Kingdom
| Phone | +44 1382 383 900 |
|---|---|
| TASCgovernance@dundee.ac.uk | |
| Website | http://www.dundee.ac.uk/ |
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Tenovus Cancer Care
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal and dissemination at national and/or international scientific conferences |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. i.mordi@dundee.ac.uk Deidentified study data upon submission of a scientific request for further analyses/study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1 | 13/04/2022 | 14/07/2022 | No | Yes |
| Protocol file | version 1 | 13/04/2022 | 14/07/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | version 2024 | 16/11/2024 | 25/11/2024 | No | No |
Additional files
Editorial Notes
25/11/2024: Basic results uploaded.
14/12/2023: The following changes were made to the study record:
1. Total final enrolment added.
2. The recruitment end date was changed from 31/03/2023 to 31/08/2023.
3. The overall study end date was changed from 31/05/2023 to 31/12/2023.
4. The intention to publish date was changed from 31/05/2024 to 31/12/2024.
04/08/2022: Internal review.
14/07/2022: Trial's existence confirmed by East of Scotland Research Ethics Service.
