Pericardial DiseaseNCT06761872
Predisposing Factors and Prevalence of Pericardial Diseases Among ESRD Patients Who Are Admitted in Critical Care Medicine Unit in Assuit University Hospital
An observational study of Pericardial Disease, run by Assiut University.
Trial summary
The main objectives of this observational study are: 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pericardial Disease
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2025to 25 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ESRD with a GFR <10 cc/min are admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.
Who may be able to join
- Patients with ESRD with a GFR <10 cc/min are admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The main objectives of this observational study are:
- Provide reliable data on the prevalence of pericardial diseases, pericardial effusion, constrictive pericarditis and its predisposing factors among ESRD patients, undergoing long-term dialysis.
- Detect the predisposing factors that could contribute to pericardial effusion amount and severity.
Participants (or their designated contact persons) will be contacted over the phone for either a telephone interview or a follow-up visit in the outpatient clinics, whatever feasible and possible.
Read the detailed description
- Inclusion Criteria: Patients with ESRD with a GFR <10 cc/min admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.
- Exclusion Criteria: 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.
- Study tools:
- Demographic data (age, sex, and comorbidities).
- Clinical data including (The etiology of ESRD). (History of stitching anterior chest pain worse on inspiration, audible friction rub, and raised JVP). (Muffled heart sounds, ascites, and lower limb edema).
- ECG for signs of pericarditis, such as concave ST segment elevation in all leads, and signs of tamponade, such as low-voltage complexes with electrical alternates.
- Doppler echocardiography by Phillips HD 11: for detection of amount and severity of pericardial effusion. The severity was defined as Small (10 < mm echo-free space behind the left ventricle). Moderate (10-20 mm, echo-free space behind the left ventricle and in front of the right ventricle in less than 1 cm). Large (>20 mm which was the mentioned finding in addition to a right-sided atrial collapse).
- Echocardiography in constrictive pericarditis shows the presence of small left ventricular dimensions with preserved systolic function, impaired diastolic function, dilated atria, abrupt termination of diastolic filling, interventricular septal bounce expiratory diastolic flow reversal in hepatic veins and tissue doppler of the medial mitral annulus is more than lateral.
- Serum calcium and phosphorus concentrations and creatinine levels in both serum and urine were elevated. Serum lipid profile, serum albumin, hormone tests such as thyroid and parathyroid along with complete blood count.
- Conditions
- Pericardial Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of variable pericardial diseases in patients with ESRD.
variable pericardial diseases in patients with ESRD.
Measured: 1 year
Secondary outcomes (1)
Detection of predisposing factors of pericardial effusion.
predisposing factors of pericardial effusion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start25 Feb 2025 (estimated)
- Primary completion25 Apr 2025 (estimated)
- Study completion25 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pericardial DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hossam Elsayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761872
- Sponsor's protocol ID
- Pericardial disease in ESRD pt
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predisposing Factors and Prevalence of Pericardial Diseases Among ESRD Patients Who Are Admitted in Critical Care Medicine Unit in Assuit University Hospital
- ClinicalTrials.gov ID
- NCT06761872
- Acronym / sponsor ID
- Pericardial disease in ESRD pt
- Conditions
- Pericardial Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (estimated)
- Primary completion
- 25 Apr 2025 (estimated)
- Study completion
- 25 Feb 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of this observational study are:
- Provide reliable data on the prevalence of pericardial diseases, pericardial effusion, constrictive pericarditis and its predisposing factors among ESRD patients, undergoing long-term dialysis.
- Detect the predisposing factors that could contribute to pericardial effusion amount and severity.
Participants (or their designated contact persons) will be contacted over the phone for either a telephone interview or a follow-up visit in the outpatient clinics, whatever feasible and possible.
Detailed description
- Inclusion Criteria: Patients with ESRD with a GFR <10 cc/min admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.
- Exclusion Criteria: 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.
- Study tools:
- Demographic data (age, sex, and comorbidities).
- Clinical data including (The etiology of ESRD). (History of stitching anterior chest pain worse on inspiration, audible friction rub, and raised JVP). (Muffled heart sounds, ascites, and lower limb edema).
- ECG for signs of pericarditis, such as concave ST segment elevation in all leads, and signs of tamponade, such as low-voltage complexes with electrical alternates.
- Doppler echocardiography by Phillips HD 11: for detection of amount and severity of pericardial effusion. The severity was defined as Small (10 < mm echo-free space behind the left ventricle). Moderate (10-20 mm, echo-free space behind the left ventricle and in front of the right ventricle in less than 1 cm). Large (>20 mm which was the mentioned finding in addition to a right-sided atrial collapse).
- Echocardiography in constrictive pericarditis shows the presence of small left ventricular dimensions with preserved systolic function, impaired diastolic function, dilated atria, abrupt termination of diastolic filling, interventricular septal bounce expiratory diastolic flow reversal in hepatic veins and tissue doppler of the medial mitral annulus is more than lateral.
- Serum calcium and phosphorus concentrations and creatinine levels in both serum and urine were elevated. Serum lipid profile, serum albumin, hormone tests such as thyroid and parathyroid along with complete blood count.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ESRD with a GFR <10 cc/min are admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.
Key inclusion criteria (1 listed)
- Patients with ESRD with a GFR <10 cc/min are admitted to the internal medicine department nephrology unit or undergoing regular hemodialysis.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of variable pericardial diseases in patients with ESRD.
Time frame: 1 year
variable pericardial diseases in patients with ESRD.
1 secondary outcome
Detection of predisposing factors of pericardial effusion.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Pericardial Disease
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
RecruitingPhase 3
Pericardial Imaging Study
Pericarditis
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Active, not recruitingObservational study
Anesthesia Management, Inflammatory Response and Recovery After Non-intubated VATS Pericardial Window
Pericardial Effusion, Inflammatory Response After Surgery
Recruiting
Prevention of Atrial Fibrillation After Cardiac Surgery by Pericardiotomy
Atrial Fibrillation (AF), Cardiac Events
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pericardial Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hossam Amgad Elsayed, resident physician (2001024113331, doc.hos17@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of variable pericardial diseases in patients with ESRD. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.