Relationship Between Cardiopulmonary Exercise Testing and Ca-P in Chronic Kidney Disease (CKD)

January 27, 2022 updated by: nooshin dalili, Shahid Beheshti University of Medical Sciences

Evaluation of the Relationship Between Cardiopulmonary Exercise Testing (CPET ) Abnormalities and Ca-P Status in CKD Stage3-5

Reductions in exercise capacity associated with exercise intolerance augment cardiovascular disease risk and predict mortality in chronic kidney disease. This study utilized cardiopulmonary exercise testing to (a) investigate mechanisms of exercise intolerance; (b) unmask subclinical ca and p and vitamin D abnormalities that may precede cardiovascular disease in chronic kidney disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cardiopulmonary exercise testing will carry out in Stage 3-5 chronic kidney disease patients ; estimated glomerular filtration rate <60 ml/min/1.73 m2) and biochemistry will be added (Ca P Via D PTH FGF23).

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All >18 years CKD Patients with GFR <60 non-dialysis

Description

Inclusion Criteria:

  • CKD Patients with GFR <60 non-dialysis
  • age<18

Exclusion Criteria:

  • HTN
  • not signing consent
  • active coronary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CKD Stage 3
CKD patients with GFR between 30-60cc/min
Diagnostic test: CPET
CPET
CKD Stage 4
CKD Patients with GFR 15-30 cc/min
Diagnostic test: CPET
CPET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Calcium x phosphorus change in stage 3-5
Time Frame: 12 MONTHS
CaxP change
12 MONTHS
CPET score change
Time Frame: 12 MONTHS
Evaluation of CPET score change
12 MONTHS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Function change
Time Frame: 12 MONTHS
GFR change
12 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Dalili, SBMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

June 23, 2019

First Submitted That Met QC Criteria

July 7, 2019

First Posted (Actual)

July 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMU2314

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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