Cardiovascular Diseases Clinical Trial
Official title:
Single Cell Leukocyte Landscapes and Cardiovascular Risk in Children With Chronic Kidney Disease
NCT number | NCT04976010 |
Other study ID # | EA2/162/17 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 17, 2021 |
Est. completion date | November 19, 2021 |
Verified date | February 2022 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Chronic kidney disease (CKD) is associated with an increased cardiovascular mortality. In particular children with early-onset CKD have a lifelong increased risk to suffer from cardiovascular disease (CVD). Therefore, children with CKD deserve our attention. The immune system in children with CKD is disturbed, exhibiting pro-inflammatory features. Therefore, we aim to learn more about the characteristics of the immune system in early-onset CKD. In this project PBMC of pediatric CKD patients and age-matched healthy controls will be analysed and compared using CITE-Seq as a multimodal scRNAseq phenotyping method. All patients will be clinically characterized to integrate cardiovascular and immunological data.
Status | Completed |
Enrollment | 38 |
Est. completion date | November 19, 2021 |
Est. primary completion date | November 19, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility | Inclusion Criteria: - matching to one of the following groups CKD G3-5: estimated eGFR according to Schwartz formula <60ml/min*1,73m2 (no ESKD) CKD G5 D: patients with ESKD treated with hemodialysis for at least 3 months normal kidney function: CKD G1 or no CKD with eGFR > 90ml/min*1,73m2 - informed consent to participate in this study Exclusion Criteria: - body weight of less than 15kg - acute or chronic inflammatory diseases - fever - diabetes - chronic liver disease - inflammatory bowel disease or other gastrointestinal disorders (constipation, diarrhea, short bowel syndrome) - antibiotic prophylaxis or treatment within four weeks prior to recruitment |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunephenotyping of human PBMC | scRNAseq with Cellular Indexing of Transcriptomes and Epitopes (CITE)-Seq for whole PBMC will be used to gain information on single cell transcriptomes across multiple immune cell populations together with expression levels of classical mmunological surface markers. | at recruitment | |
Secondary | Microbiome sequencing of fecal samples | 16S RNA amplicon sequencing and whole genome shotgun sequencing will be perfomred in fecal samples, collected in RNA/DNA shield. This will allow us insights in composition (abundances) and function of the gut microbiome. | at recruitment | |
Secondary | Targeted metabolomics of plasma samples | By using liquid-chromatography (LC) and gas-chromatography (GC) mass-spectrometry plasma samples will be analyzed for tryptophan metabolites and short chain fatty acids (absolute quantifiaction in µM). | at recruitment | |
Secondary | Pulse wave velocity | The pulse wave velocity (m/s) will be measured in all recruited patients by usinfg the Mobilograph. Data will be normalized to age. | at recruitment | |
Secondary | Carotid intima media thickness | The carotid intima media thickness (mm) will be measured using ultrasound imaging of the carotid vessel. Data will be normalized to age. | at recruitment | |
Secondary | Echocardiography | A basic echocardiography will be conducted evaluating diastolic and systolic, right and left ventricular function parameters. | at recruitment |
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