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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Perfusion; Other Postprocedural Cardiac Functional Disturbances
• Intervention / Treatment: Other: online Hemodiafiltration; Other: Hemodialysis

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: Fresenius Medical Care Deutschland GmbH

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: July 7, 2015
• First Submitted That Met QC Criteria: July 7, 2015
• First Posted (Estimate): July 10, 2015

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 14025