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Does nocturnal haemodialysis improve heart disease for patients on dialysis?

NIGHTLIFE-CMR: A cardiac MRI sub-study Investigating the impact of in-centre nocturnal haemodialysis on cardiac structure and function

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11722317
Enrollment
100
Registered
2022-08-11
Start date
2021-10-01
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemodialysis, kidney failure Urological and Genital Diseases Renal failure

Interventions

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 a

Sponsors

University of Leicester
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Global myocardial native T1 time measured by cardiac MRI at baseline and 6 months

Secondary

MeasureTime frame
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

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026