Does nocturnal haemodialysis improve heart disease for patients on dialysis?

Not Applicable

• Conditions: Haemodialysis, kidney failure; Urological and Genital Diseases; Renal failure

• Registration Number: ISRCTN11722317
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-11
• Last Update Posted: 15 July 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global myocardial native T1 time measured by cardiac MRI at baseline and 6 months

Secondary Outcome Measures

Name	Time	Method
1. Other prognostically powerful measures of cardiovascular disease assessed with cardiac MRI at baseline and 6 months<br>1.1. Left ventricular mass, volumes and ejection fraction<br>1.2. Peak systolic circumferential and longitudinal strain and early diastolic strain rates <br>1.3. Aortic stiffness assessed with aortic distensibility and aortic pulse wave velocity<br>1.4. Native T2 mapping <br>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