Rheumatoid Arthritis (RA)NCT07782788
Predictors of Cardiac Arrhythmia in Rheumatoid Arthritis Patients
An observational study of Rheumatoid Arthritis (RA), run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Nov 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria
- Age ≥18 years
- Male and female patients
Who cannot join
- 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
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
Official title: Evaluation of QT Dispersion , P Wave Dispersion and Tp-e Dispersion as Predictors of Cardiac Arrhythmia in Rheumatoid Arthritis Patients
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
Read the detailed description
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized primarily by persistent synovial inflammation and progressive joint destruction. In addition to musculoskeletal manifestations, patients with RA have an increased risk of cardiovascular morbidity and mortality compared with the general population. Cardiac arrhythmias represent one of the important cardiovascular complications in these patients and may contribute to sudden cardiac death Electrocardiographic markers reflecting abnormalities in atrial and ventricular depolarization and repolarization have gained increasing attention as predictors of arrhythmogenic risk. QT dispersion (QTd) reflects heterogeneity of ventricular repolarization and has been associated with ventricular arrhythmias. P-wave dispersion (PWD) represents inhomogeneous atrial conduction and is considered a predictor of atrial arrhythmias, particularly atrial fibrillation. Tp-e interval and Tp-e dispersion are relatively newer markers reflecting transmural dispersion of ventricular repolarization and have been linked to malignant ventricular arrhythmias Chronic inflammation, autonomic dysfunction, endothelial dysfunction and myocardial involvement in rheumatoid arthritis may contribute to abnormalities in these electrocardiographic parameters. Early identification of patients at higher risk of cardiac arrhythmias may improve risk stratification and allow timely intervention. Therefore, the present study aims to evaluate QT dispersion, P-wave dispersion and Tp-e dispersion as predictors of cardiac arrhythmias in patients with rheumatoid arthritis
- Conditions
- Rheumatoid Arthritis (RA)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Secondary outcomes (1)
Correlation between ECG parameters and disease activity assessed by DAS28
to evaluate the correlation between QT dispersion P wave dispersion Tp-e dispersion with rheumatoid arthritis disease activity assessed by DAS28
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis (RA)Studies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katreen Nabeh Henin, Assiut University
- Investigators
- katreen N henin, master, Principal investigator, faculty of medicine , Assiut university ,Eygpt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782788
- Sponsor's protocol ID
- 04-2026-201765
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11922196Gulkesen 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.
PubMed 39507840
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of QT Dispersion , P Wave Dispersion and Tp-e Dispersion as Predictors of Cardiac Arrhythmia in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT07782788
- Acronym / sponsor ID
- 04-2026-201765
- Conditions
- Rheumatoid Arthritis (RA)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 24 Aug 2026 (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.
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
Detailed description
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized primarily by persistent synovial inflammation and progressive joint destruction. In addition to musculoskeletal manifestations, patients with RA have an increased risk of cardiovascular morbidity and mortality compared with the general population. Cardiac arrhythmias represent one of the important cardiovascular complications in these patients and may contribute to sudden cardiac death Electrocardiographic markers reflecting abnormalities in atrial and ventricular depolarization and repolarization have gained increasing attention as predictors of arrhythmogenic risk. QT dispersion (QTd) reflects heterogeneity of ventricular repolarization and has been associated with ventricular arrhythmias. P-wave dispersion (PWD) represents inhomogeneous atrial conduction and is considered a predictor of atrial arrhythmias, particularly atrial fibrillation. Tp-e interval and Tp-e dispersion are relatively newer markers reflecting transmural dispersion of ventricular repolarization and have been linked to malignant ventricular arrhythmias Chronic inflammation, autonomic dysfunction, endothelial dysfunction and myocardial involvement in rheumatoid arthritis may contribute to abnormalities in these electrocardiographic parameters. Early identification of patients at higher risk of cardiac arrhythmias may improve risk stratification and allow timely intervention. Therefore, the present study aims to evaluate QT dispersion, P-wave dispersion and Tp-e dispersion as predictors of cardiac arrhythmias in patients with rheumatoid arthritis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Patients diagnosed with rheumatoid arthritis according to the 2010 ACR/EULAR classification criteria
- Age ≥18 years
- Male and female patients
Key exclusion criteria (5 listed)
- 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
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
QT dispersion, P-wave dispersion and Tp-e dispersion
Time frame: baseline
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
1 secondary outcome
Correlation between ECG parameters and disease activity assessed by DAS28
Time frame: at baseline
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 24 Aug 2026.
- Results publication: PubMed 11922196Cindas 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.
- Results publication: PubMed 39507840Gulkesen 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.
- Individual participant dataSharing planned: No
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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.
katreen N henin, master principal investigator
faculty of medicine , Assiut university ,Eygpt
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), 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 3 inclusion and 5 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 24 Aug 2026. 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 katreen N henin, master (+2001553202412, Katrin.18313203@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT dispersion, P-wave dispersion and Tp-e dispersion (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07782788, which also lists 2 linked publications.
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 24 Aug 2026.