Clinical trial NCT01781156: Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients
Official title: Effect of Reducing Phosphorus Absorption on Cardiac Biomarkers in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Failure
Keywords: phosphorus
hemodialysis
cardiac biomarkers
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Reducing cardiac biomarkers in hemodialysis patients
timeFrame: 6 months
Secondary outcomes:
measure: Improving cardiac function
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
Study officials:
affiliation: Shanghai 10th People's Hospital of Tongji University
name: Ai Peng, Ph.D,M.D
role: PRINCIPAL_INVESTIGATOR
References: