Cardiovascular Diseases Clinical Trial
Official title:
A Randomised Study Investigating the Effect of Medium Cut-Off Haemodialysis On Markers of Vascular Health Compared With On-Line HDF
The aim of this study is to evaluate haemodialysis treatment using a medium cut-off dialysis
membrane (Theranova) compared with on-line haemodiafiltration treatment with respect to
markers of endothelial health (plasma endothelial microvesicle levels, pro-inflammatory and
pro-coagulant markers).
This study will also compare the 2 treatment modalities with respect to several other outcome
measures including patient-reported outcome measures, haemodynamic parameters and advanced
glycation end-products.
To date, methods of improving outcomes for haemodialysis patients have focused on improving
small molecule clearance (urea); however, the benefits do not appear to be linear and
increasing Kt/V above 1.3 shows no benefit. Current dialysis therapies are unable to provide
effective clearance of larger "middle molecules" (between 20kDa and 60kDa) and retention of
these molecules may be linked to poor outcomes in haemodialysis patients.
Medium cut-off (MCO) dialysis membranes have been recently developed to address this area of
unmet need and provide an enhanced clearance of some larger middle molecules when compared
with high flux haemodialysis (HFHD) and even high volume haemodiafiltration (HDF). The
clinical benefit of this therapy is yet to be defined.
The aim of this study is to investigate the effect of HDx therapy (expanded haemodialysis
therapy through the use of a MCO haemodialysis membrane- Theranova) on vascular endothelial
and inflammatory biomarkers compared with high volume HDF therapy. Through the use of
endothelial microvesicles (EMV) as a marker of vascular endothelial health, which strongly
correlate with cardiovascular outcomes in end-stage real disease (ESRD) patients, this pilot
study will take the first steps into exploring whether HDx treatment provides clinical
benefits in addition to its simplicity of implementation. Additionally, other important
parameters, such as dialysis recovery time, patient-reported outcome measures and volume
management will also be explored and compared with high volume HDF.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
| Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
| Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
| Not yet recruiting |
NCT06211361 -
Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
|
N/A | |
| Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
| Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
| Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
| Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
| Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
| Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
| Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
| Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
| Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
| Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|