Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients

• Conditions: End Stage Renal Failure

• Registration Number: NCT01781156
• Lead Sponsor: Shanghai 10th People's Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-01-24
• Study First Submitted QC: 2013-01-29
• Study First Posted: 2013-01-31
• Status Verified: 2014-11
• Last Update Submitted: 2015-03-14
• Last Update Posted: 2015-03-17
• Primary Completion: 2017-02
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reducing cardiac biomarkers in hemodialysis patients	6 months

Secondary Outcome Measures

Name	Time	Method
Improving cardiac function	1 year

Trial Locations

Locations (1)

Shanghai 10th People's Hospital; 🇨🇳 Shanghai, China