Does nocturnal haemodialysis improve heart disease for patients on dialysis?
| ISRCTN | ISRCTN11722317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11722317 |
| IRAS number | 280452 |
| Secondary identifying numbers | IRAS 280452, UOL0744 |
- Submission date
- 23/08/2021
- Registration date
- 11/08/2022
- Last edited
- 03/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Heart disease is the leading cause of death for patients with kidney failure on dialysis. To stay alive, patients on haemodialysis have to have their blood cleaned 3 times a week for 4 hours in hospital by a machine. Whilst this keeps patients alive, having renal failure and being on dialysis leads to scarring in the heart which builds up over time causing the heart to fail, ultimately leading to death. The speed at which dialysis has to be done (over 4 hours) and the need to remove water quickly from these patients during dialysis are the major reasons why scarring in the heart builds up so quickly. If patients were able to have dialysis more slowly, over a longer period of time (e.g. overnight when they are asleep) this might slow or even reverse the scarring that builds up in their hearts and improve survival. It will also leave their days free to, hopefully, return to a more normal life.
The NIGHTLIFE-CMR sub-study will assess whether dialysing over a longer period of time (6-8 hours) overnight reduces levels of scarring in people’s hearts (measured with MRI) compared to staying on standard daytime dialysis.
Who can participate?
Participants from the main NightLife study (ISRCTN87042063).
What does the study involve?
Participants will be offered the opportunity to attend the hospital for separate visits to have an MRI scan of their heart at baseline and 6 months to see if extended hours night-time dialysis is beneficial for patients’ hearts and blood vessels. The scan will need to be organised on one of the days after their dialysis session to make sure the fluid levels in their body are stable. The MRI scan takes about 40 minutes during which time the participant will be lying within the MRI scanner. They will be asked to breathe in and out and hold their breath for short periods. Participants who have the MRI scan will also be asked to give some extra blood for testing at baseline and 6 months to measure for markers of heart disease in the blood. This will be the equivalent of 30ml (6 teaspoons) of blood taken at baseline and 6 months and will be taken when they are on dialysis. These test results will be analysed at the end of the study and will not be shared with the participant or alter their clinical care. This sub-study runs alongside the main NightLife study (ISRCTN87042063).
What are the possible benefits and risks of participating?
There are no guaranteed benefits to taking part in the study. All participants taking part in this study will also be helping to make a significant contribution to research into both daytime and night-time dialysis, which may improve future treatment. We hope that the results of the study will help us design improved treatments for other kidney patients in the future. With regard to risks, participants may find lying within the MRI scanner a little claustrophobic. However, the research staff will be in constant communication with the participant and the session can be stopped at any time. This scan does require an additional visit to the hospital on a different day from when they have dialysis, but this can be arranged at a convenient time for them. Participants will also be asked to give an extra blood sample for the purposes of the sub-study. However, this will be taken at the same time as the insertion and removal of their dialysis needles to ensure no further venepuncture is required.
Where is the study run from?
University of Leicester (UK)
When is the study starting and how long is it expected to run for?
January 2021 to September 2025
Who is funding the study?
British Heart Foundation
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Matthew Graham-Brown, mgb23@le.ac.uk
Prof James Burton, jb343@le.ac.uk
Kelly Parke, kelly.parke@uhl-tr.nhs.uk
Contact information
Scientific
Department of Cardiovascular Sciences
University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
 ORCID ID |
0000-0002-6197-180X |
|---|---|
| Phone | +44 (0)116252 2522 |
| mgb23@le.ac.uk |
Scientific
Department of Cardiovascular Sciences
University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
| ORCID ID |
0000-0003-1176-7592 |
|---|---|
| Phone | +44 (0)116252 2522 |
| jb343@le.ac.uk |
Scientific
Department of Cardiovascular Sciences
University of Leicester
University Road
Leicester
LE1 7RH
United Kingdom
| Phone | +44 (0)116252 2522 |
|---|---|
| kelly.parke@uhl-tr.nhs.uk |
Study information
| Study design | Two-arm multi-centre randomized controlled trial as a cardiac MRI sub-study of the NightLife study (ISRCTN87042063) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | NIGHTLIFE-CMR: A cardiac MRI sub-study Investigating the impact of in-centre nocturnal haemodialysis on cardiac structure and function |
| Study acronym | NIGHTLIFE-CMR |
| Study objectives | This study will assess whether thrice weekly, extended hours nocturnal dialysis leads to improvements in measures of cardiovascular disease assessed with cardiac MRI compared to standard daytime haemodialysis. A sub-study of ISRCTN87042063. |
| Ethics approval(s) | Approved 11/12/2020, West Midlands - Edgbaston Research Ethics Committee (The Royal College of Surgeons of Edinburgh, 85-89 Colmore Row, Birmingham, B3 2BB, UK; +44 (0)20 7104 8112; edgbaston.rec@hra.nhs.uk), REC ref: 20/WM/0275, CAG ref: 20/CAG/0136 |
| Health condition(s) or problem(s) studied | Haemodialysis, kidney failure |
| Intervention | Participants will be randomised to either: 1. Intervention arm where participants will receive 6 - 8 h of in-centre haemodialysis delivered overnight, 3 times per week for 6 months. 2. Standard care arm where participants will receive 3.5 - 5 h of in-centre haemodialysis, 3 times per week during the day for 6 months. Processes relating to recruitment and randomisation are the same as for the main NightLife study. This cardiac MRI sub-study is funded separately from the main NightLife study (British Heart Foundation, ref PG/20/10132, ISRCTN87042063) and will recruit 100 participants (50 from each randomised group) from the main NightLife study and will take place in a limited number of centres (i.e. 3 of the 18 centres participating in the main study). The sub-study will assess whether dialysing over a longer period of time (6-8 hours) overnight reduces levels of myocardial fibrosis (measured with MRI) compared to staying on conventional haemodialysis. At the centres where this sub-study is running, participants recruited to the NightLife study will have the opportunity to consent to undergo additional tests at the beginning and end of the study which will form the main outcomes from the sub-study. Cardiac structure and function will be assessed by cardiac magnetic resonance imaging (CMR) and cardiac biomarkers levels pre- and post-intervention. Myocardial fibrosis will be characterised using native T1 mapping (cardiac MRI). Outcome data, including mortality, cardiovascular events and hospitalisation will be collected. Participants recruited at centres where this sub-study is running can take part in the main NightLife study without taking part in sub-study. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Global myocardial native T1 time measured by cardiac MRI at baseline and 6 months |
| Secondary outcome measures | 1. Other prognostically powerful measures of cardiovascular disease assessed with cardiac MRI at baseline and 6 months 1.1. Left ventricular mass, volumes and ejection fraction 1.2. Peak systolic circumferential and longitudinal strain and early diastolic strain rates 1.3. Aortic stiffness assessed with aortic distensibility and aortic pulse wave velocity 1.4. Native T2 mapping 2. Myocardial fibriosis measured using blood test for high-sensitivity cardiac Troponin I, taken at the beginning and ends of dialysis sessions, at baseline and 6 months |
| Overall study start date | 01/01/2021 |
| Completion date | 30/09/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Participant in the main NightLife study (ISRCTN87042063) 2. Patients established on haemodialysis for ≥3 months (i.e. prevalent dialysis patients) 3. Aged ≥18 years 4. Able to give informed consent 5. Able to participate fully in the interventions and follow-up procedures |
| Key exclusion criteria | 1. Currently on in-centre nocturnal dialysis, or less than 3 months since stopping 2. Less than 3 months since stopping extended daytime dialysis 3. Patients for whom extended dialysis is clinically indicated (e.g. calciphylaxis, pregnancy) 4. Scheduled for living donor kidney transplant 5. Plan to change dialysis modality or centre in the next 6-months 6. Life expectancy of <6-months 7. Current participation in an interventional trial with conflicting therapies or primary outcomes 8. Absolute contraindications to a cardiac MRI scan (CMR): non-conditional devices or implants; severe claustrophobia |
| Date of first enrolment | 01/10/2021 |
| Date of final enrolment | 01/04/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Leicester
LE5 4PW
United Kingdom
Birmingham
B15 2TH
United Kingdom
Glasgow
G51 4TF
United Kingdom
Sponsor information
University/education
Research Governance Office
Research & Enterprise Division
University of Leicester
Leicester General Hospital
Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom
| Phone | +44 (0)116 258 4099/258 4867 |
|---|---|
| RGOsponsor@leicester.ac.uk | |
| Website | https://www2.le.ac.uk/colleges/medbiopsych/research/researchgovernance |
"ROR" |
https://ror.org/04h699437 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The CI will be responsible for ensuring that the results of the study are disseminated through peer review journals, conference presentations and local mechanisms at all participating centres irrespective of the outcome within six months after the final study report. Authorship on the manuscript will be determined by the CI according to contribution to the study after discussion with the TSC, and according to the guidelines of leading medical journals. The study will be reported in line with the CONSORT statement, which is an evidence-based, minimum set of recommendations for reporting randomised trials. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 4.1 | 26/09/2023 | 03/07/2024 | No | No |
Additional files
Editorial Notes
03/07/2024: Uploaded protocol (not peer-reviewed) as an additional file.
17/04/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 01/04/2024 to 01/04/2025.
2. The overall study end date was changed from 30/09/2024 to 30/09/2025.
3. The intention to publish date was changed from 30/04/2025 to 30/04/2026.
12/07/2022: Trial's existence confirmed by NHS HRA.
