CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2024/04/066338 [Registered on: 25/04/2024] Trial Registered Prospectively

Last Modified On:

24/04/2024

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Single Arm Study

Public Title of Study

Cardiac manifestations in end stage renal disease

Scientific Title of Study

Study of etiology clinical features and cardiac changes using non invasive methods in End stage renal disease (ESRD)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Pranjal Prasad Shah
Designation	Resident Doctor
Affiliation	Dr DY Patil school of medicine
Address	Dr DY Patil Hospital Near Ayyappa temple Sector 5 Nerul Navi Mumbai Near Ayyappa temple Sector 5 Nerul Navi Mumbai Thane MAHARASHTRA 400706 India
Phone	9322259248
Fax
Email	pranjalpriti@hotmail.com

Details of Contact Person
Scientific Query

Name	Dr Archana Bhate
Designation	Professor and head of unit
Affiliation	Dr DY Patil school of medicine
Address	Dr DY Patil Hospital Near Ayyappa temple Sector 5 Nerul Navi Mumbai Near Ayyappa temple Sector 5 Nerul Navi Mumbai Thane MAHARASHTRA 400706 India
Phone	9821366812
Fax
Email	archbhate@gmail.com

Details of Contact Person
Public Query

Name	Dr Pranjal Prasad Shah
Designation	Resident Doctor
Affiliation	Dr DY Patil school of medicine
Address	Dr DY Patil Hospital Near Ayyappa temple Sector 5 Nerul Navi Mumbai Near Ayyappa temple Sector 5 Nerul Navi Mumbai Thane MAHARASHTRA 400706 India
Phone	9322259248
Fax
Email	pranjalpriti@hotmail.com

Source of Monetary or Material Support

Dr DY Patil school of medicine Navi Mumbai

Primary Sponsor

Name	Dr DY Patil school of medicine
Address	Dr DY Patil school of medicine Near Ayyappa Temple Nerul sector 5 Navi Mumbai
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Pranjal Prasad Shah	Dr DY Patil School of medicine Navi Mumbai	Third floor Department of General Medicine Near Ayyappa temple Nerul sector 5 Navi Mumbai Thane MAHARASHTRA	9322259248 pranjalpriti@hotmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
D Y PATIL INSTITUITIONAL ETHICS COMMITTEE FOR BIOMEDICAL HEALTH AND RESEARCH	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N186\|\|End stage renal disease,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	All patients previously diagnosed chronic kidney disease patients with end stage renal disease stage 5 eGFR less than 15ml/min

ExclusionCriteria

Details

Patients with pre existing cardiac condition

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
To study the cardiac changes in end stage renal disease	6 moths to 1 year

Secondary Outcome

Outcome	TimePoints
To correlate cardiac changes in patients whose dialysis has been initiated and those who has not	6 months to 1 year

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

06/05/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - YES

What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identiﬁcation (text, tables, ﬁgures, and appendices).

What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiﬁed for this purpose.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response - Proposals should be directed to [pranjalpriti@hotmail.com].

For how long will this data be available start date provided 01-05-2025 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary

End stage renal disease is the permanent stage of chronic kidney disease where there is irreversible deterioration of kidney function which leads to deterioration of cardiac function . Approximately one half of mortality of patients with end stage renal disease is attributable to cardiovascular disease like coronary artery disease , valvular abnormalities , arrhythmias and cardiomyopathy .

Patients undergoing dialysis develop structural and functional cardiovascular abnormalities .

Therefore determination of cardiac diseases in patients with end stage renal disease can provide guidelines for treatment .