Clinical trial NCT02494843: Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)
Official title: Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Postprocedural Cardiac Functional Disturbances
Myocardial Perfusion
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care Deutschland GmbH
First posted: 2015-07-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF
timeFrame: 2 week
Secondary outcomes:
measure: The change in segmental cardiac perfusion during conventional HD and HDF
timeFrame: 2 week
measure: The change in global and segmental cardiac function as measured by phase-contrast MRI
timeFrame: 2 week
measure: Serum markers of cardiac damage, renal, liver function, clotting, full blood count
timeFrame: 2 weeks
measure: Reported tolerability of cardiac MRI scanning whilst having dialysis
timeFrame: On 2 MRI study days
Other outcomes:
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