NCT04441346

Brief Summary

This study aims : To assess the frequency of heart failure in patients with end-stage renal disease on regular dialysis. To identify the risk factors of heart failure in patients with end-stage renal disease. To assess the impact of duration of dialysis on heart failure and its prognosis

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
289

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

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

June 1, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

June 6, 2020

Last Update Submit

June 19, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • risk factors of CHF in hemodialysis patients

    identification of risk factors using demographic and disease characteristics of the patient as age, gender, systolic and diastolic blood pressure, dialysis access, frequency and duration of HD

    July 2020 to July 2021

  • incidence of CHF in hemodialysis patients

    identification of CHF in ESRD patients using echocardiography

    July 2020 to July 2021

Secondary Outcomes (1)

  • impact of duration of dialysis on heart failure

    July 2020 to July 2021

Study Arms (3)

patients with recent hemodialysis(less than 6 month

Radiation: Echocardiography

patients on hemodialysis more than 6 months and l

Radiation: Echocardiography

patients on hemodialysis more than 5 years

Radiation: Echocardiography

Interventions

test that uses high frequency sound waves (ultrasound) to make pictures of your heart.

patients on hemodialysis more than 5 yearspatients on hemodialysis more than 6 months and lpatients with recent hemodialysis(less than 6 month

Eligibility Criteria

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

Dialysis unit of Internal Medicine Department in Assiut University Hospital

You may qualify if:

  • ESRD patient on regular hemodialysis

You may not qualify if:

  • AKI patients on HD
  • Patients discontinued therapy during the study period will be excluded.
  • Patients with structural heart disease (congenital or valvular heart disease)
  • Patients with obstructive or restrictive lung diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor, internal medicine department, principal investigator

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 22, 2020

Study Start

June 1, 2020

Primary Completion

October 1, 2021

Study Completion

November 1, 2021

Last Updated

June 22, 2020

Record last verified: 2020-06