NCT02494843

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Other Postprocedural Cardiac Functional Disturbances
• Myocardial Perfusion

Interventions

Type	Name	Description
OTHER	online Hemodiafiltration	Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
OTHER	Hemodialysis	Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-03-01
• Completion: 2015-12-31
• First posted: 2015-07-10
• Last updated: 2020-04-30