NCT06761872

Brief Summary

The main objectives of this observational study are:

  1. 1.Provide reliable data on the prevalence of pericardial diseases, pericardial effusion, constrictive pericarditis and its predisposing factors among ESRD patients, undergoing long-term dialysis.
  2. 2.Detect the predisposing factors that could contribute to pericardial effusion amount and severity.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

December 31, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 25, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2026

Completed
Last Updated

January 7, 2025

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 31, 2024

Last Update Submit

January 6, 2025

Conditions

Pericardial Disease

Outcome Measures

Primary Outcomes (1)

  • Detection of variable pericardial diseases in patients with ESRD.

    variable pericardial diseases in patients with ESRD.

    1 year

Secondary Outcomes (1)

  • Detection of predisposing factors of pericardial effusion.

    1 year

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ESRD with a GFR \<10 cc/min are admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.

You may qualify if:

  • Patients with ESRD with a GFR \<10 cc/min are admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.

You may not qualify if:

  • Patients presented with non-uremic pericarditis such as intra-thoracic malignancy, injury (thoracic, oesophageal, and iatrogenic trauma), pulmonary TB, autoimmune diseases, history suggestive of recent viral infection, myxedema, and severe HF.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Hossam Amgad Elsayed, resident physician

CONTACT

2001024113331doc.hos17@icloud.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

December 31, 2024

First Posted

January 7, 2025

Study Start

February 25, 2025

Primary Completion

April 25, 2025

Study Completion

February 25, 2026

Last Updated

January 7, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share