Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Shanghai 10th People's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Ai Peng, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier:
NCT01781156
First received: January 24, 2013
Last updated: January 29, 2013
Last verified: July 2012
  Purpose

Hyperphosphatemia and elevated cardiac biomarkers are two key characteristics of patients in end stage renal diseases(ESRD),however the majority of whom are in the absence of acute coronary syndrome(ACS). And it is still unclear why cardiac biomarkers would increase in those patients. We hypothesized that excessive phosphorus is account for that phenomenon.To confirm that hypothesis,we used one phosphorus binder to reduce phosphorus absorption in hemodialysis patients for some time and observed the change of cardiac biomarkers of those patients.


Condition
End Stage Renal Failure

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Shanghai 10th People's Hospital:

Primary Outcome Measures:
  • Reducing cardiac biomarkers in hemodialysis patients [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improving cardiac function [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Cardiovascular disease is one of the leading causes of morbidity and mortality in patient with chronic kidney disease(CKD), accounting for more than 50% of all deaths.When myocardial cells get injured, cardiac biomarkers will be released into the circulation. Elevated cardiac biomarkers have been observed in patients with various degrees of renal failure. However, the majority of those CKD patients are in the absence of acute coronary syndrome. So far, it is still unclear the mechanisms of the increased biomarkers in CKD patients. Meanwhile, hyperphosphatemia is one of the major features of CKD, particularly of end stage renal disease(ESRD). Lots of evidences have shown that high levels of serum phosphorus and an elevation of the serum calcium × phosphorus product can lead to cardiovascular calcifications and subsequent cardiovascular morbidity and mortality in patients with CKD.it is tempting to hypothesize that hyperphosphatemia may be responsible for the rise of cardiac biomarkers in CKD patients.So we use one phosphate binder to reduce phosphorus absorption in hemodialysis patients for one year and observe the change of cardiac biomarkers of those patients.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The population will be selected from patients of nephrology department of Shanghai 10th people's hospital in Shanghai,China.

Criteria

Inclusion Criteria:

  • Time of receiving hemodialysis is more than 1 year;
  • Hyperphosphatemia before hemodialysis;
  • Never use any phosphorus binder in the past 6 months.

Exclusion Criteria:

  • Receiving coronary artery stent implantation before;
  • Having any cardiovascular disease in the past 6 months;
  • Cannot tolerate the side effects of phosphorus binder;
  • Dose not take medicine according to the prescription;
  • inadequate dialysis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781156

Contacts
Contact: Ai Peng, Ph.D,M.D 86-021-66302524 pengai@hotmail.com
Contact: Shu Wang, M.D 86-021-66302527 sisisi_wang@hotmail.com

Locations
China
Shanghai 10th People's Hospital Recruiting
Shanghai, China, 200072
Contact: Ai Peng, Ph.D,M.D    86-021-66302524    pengai@hotmail.com   
Sub-Investigator: Shu Wang, M.D         
Sponsors and Collaborators
Shanghai 10th People's Hospital
Investigators
Principal Investigator: Ai Peng, Ph.D,M.D Shanghai 10th People's Hospital of Tongji University
  More Information

No publications provided

Responsible Party: Ai Peng, Director of the department of Nephrology, Shanghai 10th poeple's hospital, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT01781156     History of Changes
Other Study ID Numbers: 2012RES-047, 81270136
Study First Received: January 24, 2013
Last Updated: January 29, 2013
Health Authority: China: National Natural Science Foundation

Keywords provided by Shanghai 10th People's Hospital:
phosphorus
hemodialysis
cardiac biomarkers

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 18, 2014