Relationship Between Cardiopulmonary Exercise Testing and... | NCT04013139

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

NCT04013139

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Jan 28, 2022Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Ckd-Mbd

Interventions

CPET

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Oct 1, 2021Actual

First Submitted Date

Jun 23, 2019

First Submission Date that Met QC Criteria

Jul 7, 2019

First Posted Date

Jul 9, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2022

Last Update Posted Date

Jan 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

nooshin dalili, Principal Investigator, Shahid Beheshti University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shahid Beheshti University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD Stage 3		CKD patients with GFR between 30-60cc/min	Diagnostic Test: CPET
CKD Stage 4		CKD Patients with GFR 15-30 cc/min	Diagnostic Test: CPET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPET	Diagnostic Test	CPET	CKD Stage 3 CKD Stage 4

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Renal Function change	GFR change	12 MONTHS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

HTN
not signing consent
active coronary disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Dalili	SBMU	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012080	Chronic Kidney Disease-Mineral and Bone Disorder

Ancestor Terms

ID	Term
D012279	Rickets
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided