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Status unknownNCT03360331Updated Dec 4, 2017

Effect of Phosphorus on Valvular and Vascular Calcification in ESRD

An observational study in Vascular Calcification, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-12-04.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
18 Years to 40 Years
Sex
All
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Study summary

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

Read the 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

02

Conditions studied

  • Vascular Calcification
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients with hypercalcemia or hyperlipidemia or diabetic patients
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Decrease the cardiovascular complications in ESRD patients

    Find the relationship between phosphorus and valvular and vascular calcification in ESRD PATIENTS

    Time frame: one year

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03360331
Lead sponsor
Assiut University
Responsible party
Noha Gamal Abdelmalik (Doctor, Assiut University) — Principal investigator
First posted
Dec 4, 2017
Start date
Dec 1, 2017 (estimated)
Primary completion
Nov 1, 2018 (estimated)
Completion
Dec 1, 2018 (estimated)
Last update
Dec 4, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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