Circulating lncRNA and CV Morbidities in CKD and ESRD

NCT02304471 | Unknown DMC

• 1 other identifier: 201409019RINB
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiovascular disease is the major cause of morbidity and death in patients with chronic kidney disease (CKD) and end-stage renal disease (ESRD). The mechanisms linking impaired renal function and increased risk for cardiovascular diseases, however, remain elusive. Long non-coding RNAs (lncRNAs) is a heterogeneous group of non-coding transcripts longer than 200 nucleotides. While the roles of lncRNAs in human diseases including cancer and neurodegenerative disorders are beginning to emerge, it remains unclear how lncRNA regulation contributes to cardiovascular complications in patients with renal dysfunction. In this proposal, the investigators seek to apply next-generation sequencing technology to investigate circulating lncRNA expression in control subjects and in patients with CKD and ESRD. The investigators will test the hypothesis that circulating lncRNA expression signature can reflect the underlying kidney disease states in patients with CKD and ESRD. A gene co-expression network analysis will be conducted to identify lncRNAs that are functionally involved in the pathogenesis of CKD and ESRD. Next, the investigators will identify circulating lncRNAs that are indicative of cardiovascular dysfunction in ESRD patients. Finally, the investigators propose to test the hypothesis that circulating lncRNAs can be novel prognostic biomarkers to predict cardiovascular outcomes and renal function progression in CKD patients. The results from these experiments will lead to better understanding of how circulating lncRNAs contribute to uremic cardiovascular complications and renal function progression.

Conditions

Chronic Kidney Disease; End-stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• Adverse cardiovascular events (acute myocardial ischemia, life-threatening atrial/ventricular arrhythmias, acute decompensated heart failure, stroke and cardiovascular death)

  Adverse cardiovascular events including acute myocardial ischemia, life-threatening atrial/ventricular arrhythmias, acute decompensated heart failure, stroke and cardiovascular death will be recorded over the follow-up period.

  3 years

Study Arms (3)

Control

healthy subjects

CKD

chronic kidney disease

ESRD

end-stage renal disease

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CKD, ESRD, Healthy controls

You may qualify if:

• Adult patients with various stages 1-5 of CKD will be enrolled at outpatient clinic. Definition and staging of CKD were defined by estimated glomerular filtration rate by the Modification of Diet in Renal Disease study equation.
• Patients with ESRD under maintenance hemodialysis or peritoneal dialysis will also be included.

You may not qualify if:

• age younger than 20 years or older than 80 years.
• pregnant woman.
• patients already received kidney transplantation.
• recent hospitalization within previous one month.
• for ESRD patients, receiving maintenance hemodialysis or peritoneal dialysis for less than 3 months.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chun-Fu Lai, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Fu Lai, M.D.

CONTACT

+886-2-23123456; s821052@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 2, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2018
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

TW (1)