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

Not Applicable

Completed

• Conditions: Myocardial Perfusion; Other Postprocedural Cardiac Functional Disturbances
• Interventions: Other: online Hemodiafiltration; Other: Hemodialysis

• Registration Number: NCT02494843
• Lead Sponsor: University of Nottingham

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.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-03
• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-10
• Study Completion: 2015-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-29
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Online haemodiafiltration	online Hemodiafiltration	-
Online haemodiafiltration	Hemodialysis	-
Haemodialysis	Hemodialysis	-
Haemodialysis	online Hemodiafiltration	-

Primary Outcome Measures

Name	Time	Method
The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF	2 week

Secondary Outcome Measures

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