Dynamic Effects of Online HDF on Cardiac Function and Myocardial Perfusion Utilising Cardiac MRI (CAMRID)
CAMRID
1 other identifier
interventional
12
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
July 10, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2015
CompletedApril 30, 2020
April 1, 2020
4 months
July 7, 2015
April 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The change in global cardiac perfusion (ml/min/100g) between conventional HD and HDF
2 week
Secondary Outcomes (4)
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
2 weeks
Reported tolerability of cardiac MRI scanning whilst having dialysis
On 2 MRI study days
Study Arms (2)
Online haemodiafiltration
ACTIVE COMPARATORHaemodialysis
ACTIVE COMPARATORInterventions
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nottinghamlead
- Fresenius Medical Care Deutschland GmbHcollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2015
First Posted
July 10, 2015
Study Start
November 1, 2014
Primary Completion
March 1, 2015
Study Completion
December 31, 2015
Last Updated
April 30, 2020
Record last verified: 2020-04