NCT07455799

Brief Summary

the effect of missed hemodialysis sessions on the occurrence of short-term cardiovascular events in patients with end-stage renal disease receiving maintenance hemodialysis.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

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

March 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 3, 2026

Last Update Submit

March 12, 2026

Conditions

Keywords

Renal failureMissed sessions of HD

Outcome Measures

Primary Outcomes (1)

  • Incidence of short-term cardiovascular events (CVE) following missed hemodialysis sessions

    Short-term cardiovascular events will be defined as the occurrence of acute coronary syndrome, acute decompensated heart failure, documented arrhythmias, sudden cardiac death, or cerebrovascular events occurring within 72 hours after a missed hemodialysis session.

    1 year

Interventions

A standard 12-lead ECG will be performed for all patients within 72 hours after a missed hemodialysis session to detect abnormalities.Transthoracic echocardiography will be performed as a baseline assessment for all enrolled patients using routine institutional protocols. Repeat echocardiographic examination will be performed only if clinically indicated,Echocardiographic parameters assessed will include left ventricular ejection fraction , left ventricular hypertrophy, regional wall motion abnormalities, diastolic function, and right ventricular function

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hemodialysis Unit of Internal Medicine Department

You may qualify if:

  • Adult patients aged ≥18 years.
  • Patients diagnosed with end-stage renal disease (ESRD).
  • Patients receiving maintenance hemodialysis on a regular schedule (three sessions per week).
  • Patients on maintenance hemodialysis for at least 3 months prior to enrolment.

You may not qualify if:

  • Patients receiving peritoneal dialysis or other forms of renal replacement therapy.
  • Patients with acute kidney injury requiring temporary dialysis.
  • Patients with documented acute cardiovascular events within 30 days prior to study enrolment.
  • Patients who undergo renal transplantation during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Assiut Governorate, Egypt

Location

Related Publications (11)

  • Kumar P, Savant K, Balakrishnan A, Nair S, Prabhu Attur R. Impact of Interdialytic Intervals on Sudden Cardiac Death in Chronic Kidney Disease Stage 5D Patients on a Twice-Weekly Hemodialysis Schedule. Kidney Blood Press Res. 2025;50(1):420-428. doi: 10.1159/000546184. Epub 2025 May 7.

  • Zhang Y, Wang J, Xing Y, Cui C, Cheng H, Chen Z, Chen H, Liu C, Wang N, Chen M. Dynamics of Cardiac Autonomic Responses During Hemodialysis Measured by Heart Rate Variability and Skin Sympathetic Nerve Activity: The Impact of Interdialytic Weight Gain. Front Physiol. 2022 May 16;13:890536. doi: 10.3389/fphys.2022.890536. eCollection 2022.

  • Lim K, Nayor M, Arroyo E, Burney HN, Li X, Li Y, Shah R, Campain J, Wan D, Ting S, Hiemstra TF, Thadhani R, Moe S, Zehnder D, Larson MG, Vasan RS, Lewis GD. Impairment of Cardiovascular Functional Capacity in Mild-to-Moderate Kidney Dysfunction. Clin J Am Soc Nephrol. 2024 Dec 1;19(12):1547-1561. doi: 10.2215/CJN.0000000000000548. Epub 2024 Oct 14.

  • Canaud B, Kooman JP, Selby NM, Taal M, Maierhofer A, Kopperschmidt P, Francis S, Collins A, Kotanko P. Hidden risks associated with conventional short intermittent hemodialysis: A call for action to mitigate cardiovascular risk and morbidity. World J Nephrol. 2022 Mar 25;11(2):39-57. doi: 10.5527/wjn.v11.i2.39.

  • Fatovic-Ferencic S, Holubar K. The portrait and paper of a forgotten hero--Luca Stulli (1772-1828) and the Mal de Meleda of yesteryear: a 175-year anniversary. J Invest Dermatol. 2001 Jan;116(1):198-9. doi: 10.1046/j.1523-1747.2001.00225.x. No abstract available.

  • Hospice nursing. A special calling. Nursing. 1997 Jan;27(1):52-7. No abstract available.

  • Matise MP, Joyner AL. Gli genes in development and cancer. Oncogene. 1999 Dec 20;18(55):7852-9. doi: 10.1038/sj.onc.1203243.

  • Williams P, Keshavarz-Moore E, Dunnill P. Production of cadmium sulphide microcrystallites in batch cultivation by Schizosaccharomyces pombe. J Biotechnol. 1996 Jul 31;48(3):259-67. doi: 10.1016/0168-1656(96)01520-9.

  • Stuard S, Maddux FW, Canaud B. Why High-Volume Post-Dilution Hemodiafiltration Should Be the New Standard in Dialysis Care: A Comprehensive Review of Clinical Outcomes and Mechanisms. J Clin Med. 2025 Jul 9;14(14):4860. doi: 10.3390/jcm14144860.

  • Marinetti MT. Health workforce shortage in the United Kingdom and prospects of personnel recruitment from abroad. Cah Sociol Demogr Med. 2003;43(1):71-114. No abstract available.

  • Francis A, Harhay MN, Ong ACM, Tummalapalli SL, Ortiz A, Fogo AB, Fliser D, Roy-Chaudhury P, Fontana M, Nangaku M, Wanner C, Malik C, Hradsky A, Adu D, Bavanandan S, Cusumano A, Sola L, Ulasi I, Jha V; American Society of Nephrology; European Renal Association; International Society of Nephrology. Chronic kidney disease and the global public health agenda: an international consensus. Nat Rev Nephrol. 2024 Jul;20(7):473-485. doi: 10.1038/s41581-024-00820-6. Epub 2024 Apr 3.

MeSH Terms

Conditions

Renal Insufficiency, ChronicRenal Insufficiency

Interventions

ElectrocardiographyEchocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisCardiac Imaging TechniquesDiagnostic ImagingUltrasonography

Study Officials

  • Mohamed Ali Touhami Ibrahim, Professor

    PRINCIPAL INVESTIGATOR
  • Eman Mohamed Ibrahim Kamed Hussain, Assistant lecture

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amna Abdelnasser Taher, Resident

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 6, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations