ERKNet

The European Rare Kidney Disease Reference Network

  

Research Project

Project Title:

Effects of Haemodiafiltration (HDF) vs Conventional Haemodialysis (HD) on Growth and Cardiovascular Markers in Children - 3H (HDF, Hearts and Height) Study

Project Type:

Clinical Trial, Enrolment terminated
Adjunct biobank: Serum

Disease group(s):

Pediatric CKD & dialysis

Project Summary:

Children on conventional haemodialysis (HD) die of heart disease. Also, they can be malnourished and short. Haemodiafiltration (HDF) is a newer type of dialysis that achieves better removal of toxins and excess fluid than HD. On HDF, adults have a longer survival and children show improved growth, but mechanisms are not understood.

We have recruited 190 children from 28 centres across the EU to compare HDF and HD. We are monitoring growth, heart and blood vessel scans, biomarkers and quality of life. If the 3H (HDF-Hearts-Height) study shows reduced cardiovascular morbidity and better growth, HDF may be adopted as the preferred type of dialysis in children.

Primary Outcome Measures:
• 1. Change in carotid artery intima-media thickness (cIMT) standard deviation score (SDS) [ Time Frame: 12 months ]
• Change in height SDS [ Time Frame: 12 months ]

Secondary Outcome Measures:
• For nutritional status 1. Body mass index SDS 2. Markers of appetite regulation and nutritional status [ Time Frame: 6 months ]
• For cardiovascular status 1. 24-hour mean arterial BP SDS 2. Left ventricular mass index 3. Pulse wave velocity SDS 4. Biomarkers of cardiovascular disease [ Time Frame: 12 months ]
• Quality of life (QoL) questionnaires [ Time Frame: 12 months ]

Lead principal investigator(s):

Rukshana Shroff, London

Co-investigator(s):

Franz Schaefer, Heidelberg
Claus Peter Schmitt, Heidelberg

Project Period:

09/2013   -   12/2020

Sponsors:

National funding agency

Project web page:

http://www.pedpd.org/

ClinicalTrials.gov:

NCT02063776

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