Effect of Phosphorus on Valvular and Vascular Calcification in ESRD

Evaluation of the calcifying effect of phosphorus on vascular smooth muscle and detect the association between serum phosphorus and valvular and vascular calcification in end stage renal disease patients

Study Overview

• Status: Unknown
• Conditions: Vascular Calcification

Detailed Description

Cardiovascular disease (CVD) is the main cause of death in patients with end stage renal disease(ESRD). It is estimated that ESRD patients are 5 to 20 times more likely to die because of cardiovascular causes than the general population .

Traditional cardiovascular risk factors do not completely explain higher mortality rates among hemodialysis patients , and non traditional risk factors such as anemia, bone mineral disease, hyperhomocysteinemia, inflammation, hypercoagulability, and left ventricular hypertrophy (LVH) have been demonstrated to play an important role in this population.

A number of factors have been associated with progression of vascular calcification(VC) in dialysis patients. Associations with age and duration of dialysis , diabetes mellitus ,abnormalities of mineral metabolism as well as use and dose of calcium based phosphate binders have all been reported.

Hyperphosphatemia is a common problem among patients with ESRD. It is a highly prevalent condition, as almost 40% of the U.S. hemodialysis population has a serum phosphate( PO4) greater than 6.5 mg/dl . The overall mortality risk associated with serum phosphate( PO4) above 6.5 mg/dl was 27% greater than that of patients with PO4 levels between 2.4 and 6.5 mg/dl. It is speculated that elevate PO4 may aggravate the effects of coronary atherosclerosis through increased vascular calcification and smooth muscle proliferation . It has also been suggested that myocardial calcification, a consequence of elevated PO4, may alter microcirculatory hemodynamics through increased extravascular resistance and further compromise myocardial perfusion. We, therefore, hypothesized that the increased mortality risk associated with elevated PO4 levels was primarily related to cardiac rather than non-cardiac causes of death.

A number of non-invasive imaging techniques are now available to detect and quantify vascular calcification (VC). Indeed, plain x-rays of abdomen and extremities to identify macroscopic calcifications of aorta and peripheral arteries;echocardiography for assessment of valvular calcification;2D-ultrasound for calcification of carotid arteries, femoral arteries and aorta and computed tomography technologies constitute the current armamentarium for detection and quantification of cardiovascular calcification (VC) and its progression.

Electron beam computed tomography (EBCT) and multi-slice computed tomography (MSCT) represent the gold standard for assessing the extent of coronary artery and aorta calcification.MSCT is more widely available than EBCT

• Study Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ESRD patients on regular dialysis for five years duration aging 18 to40 years old

Description

Inclusion Criteria:

• ESRD patients on regular dialysis of five years duration aging 18 to 40 years

Exclusion Criteria:

• patients with hypercalcemia or hyperlipidemia or diabetic patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease the cardiovascular complications in ESRD patients	Find the relationship between phosphorus and valvular and vascular calcification in ESRD PATIENTS	one year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2017
• Primary Completion (ANTICIPATED): November 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: November 5, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (ACTUAL): December 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis; Vascular Calcification
• Other Study ID Numbers: calcification in ESRD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No