NCT07782788

Brief Summary

To evaluate QT dispersion, P-wave dispersion and Tp-e dispersion as predictors of cardiac arrhythmias in patients with rheumatoid arthritis and to assess their relationship with disease characteristics and inflammatory activity

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
13mo left

Started Oct 2026

Status
not yet 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

First Submitted

Initial submission to the registry

August 20, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
1 month 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

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 20, 2026

Last Update Submit

August 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • QT dispersion, P-wave dispersion and Tp-e dispersion

    to assess QT dispersion , P wave dispersion and Tp-e dispersion on 12 lead ECG and compare their values between rheumatoid arthritis patients and healthy controls and to evaluate their association with the risk of cardiac arrhythmia

    baseline

Secondary Outcomes (1)

  • Correlation between ECG parameters and disease activity assessed by DAS28

    at baseline

Study Arms (2)

group 1 rheumatoid arthritis patients

rheumatoid arthritis patients diagnosed according to 2010 ACR\\EULAR criteria

group 2 healthy controls

healthy controls without RA meeting study eligibility criteria

Eligibility Criteria

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

adult male and female participants aged ≥18 years, including patients with rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria and age- and sex matched healthy controls. Participants with other autoimmune diseases, thyroid disorders, cardiac diseases, electrolyte abnormalities (hypocalcemia, hypokalemia, or hypomagnesemia), or use of drugs known to affect cardiac rhythm such as amiodarone will be excluded

You may qualify if:

  • Patients diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria
  • Age ≥18 years
  • Male and female patients

You may not qualify if:

  • Presence of other autoimmune diseases
  • Thyroid disorders
  • Use of medications affecting cardiac conduction or repolarization such as amiodarone and other antiarrhythmic drugs
  • Electrolyte disturbances including hypocalcemia, hypokalemia and hypomagnesemia
  • Known cardiac diseases including ischemic heart disease, valvular heart disease, cardiomyopathy, heart failure or congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Cindas A, Gokce-Kutsal Y, Tokgozoglu L, Karanfil A. QT dispersion and cardiac involvement in patients with rheumatoid arthritis. Scand J Rheumatol. 2002;31(1):22-6. doi: 10.1080/030097402317255327.

  • Gulkesen A, Yildirim Uslu E, Akgol G, Alkan G, Kobat MA, Gelen MA, Uslu MF. Is the development of arrhythmia predictable in rheumatoid arthritis? Arch Rheumatol. 2024 Aug 26;39(3):429-435. doi: 10.46497/ArchRheumatol.2024.10590. eCollection 2024 Sep.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • katreen N henin, master

    faculty of medicine , Assiut university ,Eygpt

    PRINCIPAL INVESTIGATOR

Central Study Contacts

katreen N henin, master

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 20, 2026

First Posted

August 24, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

August 24, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share