The Impact of Conventional Hemodialysis and Renal Transpl... | NCT05685823

Studies
The Impact of Conventional Hemodialysis and Renal Transplantation on the Global Longitudinal Strain of the Left Ventricle

NCT05685823

Sponsor

Grigore T. Popa University of Medicine and Pharmacy

Status

Unknown status

Last Update Posted

Jan 17, 2023Actual

Enrollment

140Actual

Phase

Not provided

Conditions

Cardiovascular Diseases
Chronic Kidney Diseases
Fibrosis

Interventions

Not provided

Countries

Romania

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 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Jan 8, 2023

First Submission Date that Met QC Criteria

Jan 8, 2023

First Posted Date

Jan 17, 2023Actual

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 8, 2023

Last Update Posted Date

Jan 17, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ureche Carina, MD, Grigore T. Popa University of Medicine and PharmacyPrincipal Investigator

Lead Sponsor

Grigore T. Popa University of Medicine and PharmacyOTHER

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

The objective of this study is to evaluate a group of patients with chronic kidney disease in stages 3-5 by conventional 2D echocardiography, tissue Doppler techniques and speckle tracking - LV GLS and determine the correlation of ultrasound parameters with mortality. Additionally, fibrosis-related biomarkers will be studied in this population.

Detailed Description

Not provided

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

140Actual

Measure	Description	Time Frame
Variation of GLS		3 years
All-cause mortality		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

eGFR < 15 ml/min/1.73m2 (CKD - EPI)
NYHA class I-II
Hemodynamic stability

Exclusion Criteria:

age < 18 years old
poor acoustic window
atrial fibrillation
recent Acute Myocardial Infarction
pacemaker

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

Patients with advanced chronic kidney disease, pre-dialysis or pre-transplant, in the records of the Clinical Hospital "Dr. C. I. Parhon" Iasi

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gr T Popa University of Medicine and Pharmacy		Iași			Romania

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D051436	Renal Insufficiency, Chronic
D005355	Fibrosis

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided