Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients

End Stage Renal Failure Clinical Trial

Official title:

Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01781156
• Other study ID #: 2012RES-047
• Secondary ID: 81270136
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2013
• Last updated: March 14, 2015
• Start date: August 2012
• Est. completion date: June 2018

Study information

• Verified date: November 2014
• Source: Shanghai 10th People's Hospital
• Contact: Ai Peng, Ph.D,M.D
• Phone: 86-021-66302524
• Email: pengai[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• End Stage Renal Failure
• Kidney Failure, Chronic

Locations

Country	Name	City	State
China	Shanghai 10th People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing cardiac biomarkers in hemodialysis patients		6 months	Yes
Secondary	Improving cardiac function		1 year	Yes