NCT05685823

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

January 8, 2023

Last Update Submit

January 8, 2023

Conditions

Cardiovascular DiseasesChronic Kidney DiseasesFibrosis

Outcome Measures

Primary Outcomes (2)

  • Variation of GLS

    3 years

  • All-cause mortality

    3 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gr T Popa University of Medicine and Pharmacy

Iași, Romania

Location

MeSH Terms

Conditions

Cardiovascular DiseasesRenal Insufficiency, ChronicFibrosis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 17, 2023

Study Start

October 1, 2019

Primary Completion

January 1, 2021

Study Completion

October 31, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Locations

RO(1)