NCT06221891

Brief Summary

The goal of this observational study is to learn about the value of multimodal ultrasound in early detection of left ventricular systolic dysfunction in patients with chronic kidney disease(CKD). The main questions it aims to answer are:

  1. 1.If first-phase ejection fraction(EF1)could early detect the left ventricular systolic dysfunction in patients with CKD.
  2. 2.Whether EF1 can detect left ventricular systolic dysfunction in patients with CKD more sensitively than speckle-tracking echocardiography and myocardial work.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

January 16, 2024

Last Update Submit

April 10, 2024

Conditions

Keywords

first phase ejection fraction;left ventricular systolic dysfunction;echocardiography;chronic kidney disease

Outcome Measures

Primary Outcomes (1)

  • first-phase ejection fraction

    an ultrasound indicator used to assess early left ventricular systolic function

    1 hour

Study Arms (2)

case group

This group contains the patients with chronic kidney disease.

control group

This group contains the healthy adults.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.

You may qualify if:

  • Patients with chronic kidney disease who are hospitalized in The Fifth Affiliated Hospital of Sun Yat-sen University.
  • LVEF≥50%.

You may not qualify if:

  • Patients with primary hypertension, diabetes and congenital heart disease.
  • Patients who are pregnant or lactating.
  • Patients with the blurry ultrasound images.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, ChronicVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 24, 2024

Study Start

October 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations