Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)

Study Overview
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Brief Summary
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The purpose of this study is to characterise, in detail, the cardiac structure, function and perfusion of those on haemodialysis and haemodiafiltration, comparing the two modalities to ascertain if haemodiafiltration provides relative myocardial protection compared to conventional haemodialysis.

Detailed Description
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Trial Configuration: Non-blinded crossover pilot study Setting: Secondary care Sample size estimate: This is a pilot study therefore power calculations are not appropriate. A group size of 12 participants has been selected for feasibility. Number of participants: 12 patients to complete study Description of interventions 6 sessions of conventional haemodialysis each lasting 4 hours 6 sessions of online haemodiafiltration each lasting 4 hours 2 sessions of Cardiac MRI each lasting 6 hours in total to take place around 6th session of dialysis Randomisation and blinding: This is an open study. Statistical methods: All continuous variables will be tested for normality. The primary and continuous secondary endpoints will be compared between the two modalities using a paired t test or Wilcoxon signed rank test as appropriate. The association between categorical variables will be tested using the Chi squared or Fischer's Exact test. An alpha error at 0.05 will be judged as significant.

Official Title
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Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)

Conditions
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Other Postprocedural Cardiac Functional Disturbances, Myocardial Perfusion

Intervention / Treatment
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* Other: online Hemodiafiltration
* Other: Hemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years Able to give informed consent CKD5 on chronic haemodialysis Receiving dialysis via an arteriovenous fistula Must be able to follow simple instruction in English (on safety grounds for MRI scans) Exclusion Criteria: Change in ideal dry weight in 4 weeks prior to recruitment Instability on dialysis in 4 weeks prior to recruitment leading to either: Emergency medical attention Infusion of additional fluid Loss in consciousness Arrhythmia Chest pain Dialysed via a synthetic line or graft Qa < 500ml/min NYHA Stage IV heart failure Active infection or malignancy Contraindication to MRI scanning including claustrophobia Mental incapacity to consent Pregnancy or planning pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Online haemodiafiltration<br> | Other: online Hemodiafiltration<br>* Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.<br>* Other names: Hemodiafiltration;Other: Hemodialysis<br>* Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.<br>* Other names: Haemodialysis;|
| Active Comparator: Haemodialysis<br> | Other: online Hemodiafiltration<br>* Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.<br>* Other names: Hemodiafiltration;Other: Hemodialysis<br>* Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.<br>* Other names: Haemodialysis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF |  | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in segmental cardiac perfusion during conventional HD and HDF |  | 2 week | 
| The change in global and segmental cardiac function as measured by phase-contrast MRI |  | 2 week | 
| Serum markers of cardiac damage, renal, liver function, clotting, full blood count | Bloods collected at the end of 2 week study period on the scan days on HD and HDF | 2 weeks | 
| Reported tolerability of cardiac MRI scanning whilst having dialysis | On 2 MRI study days | On 2 MRI study days |