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

Myocardial Perfusion Clinical Trial

— CAMRID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02494843
• Other study ID #: 14025
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 31, 2015

Study information

• Verified date: April 2020
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Myocardial Perfusion
• Other Postprocedural Cardiac Functional Disturbances

Intervention

Other:
• online Hemodiafiltration
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
• Hemodialysis
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Fresenius Medical Care Deutschland GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF		2 week
Secondary	The change in segmental cardiac perfusion during conventional HD and HDF		2 week
Secondary	The change in global and segmental cardiac function as measured by phase-contrast MRI		2 week
Secondary	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
Secondary	Reported tolerability of cardiac MRI scanning whilst having dialysis	On 2 MRI study days	On 2 MRI study days