Warfarin Quality, Adherence, Range, Determinants, and Events in Egyptian Rheumatic Heart Disease and Atrial Fibrillation

NOT YET RECRUITING

NCT07826299

Sponsor: Assiut University

Summary

No Egyptian study has systematically quantified TTR, identified its predictors, or linked anticoagulation quality to clinical outcomes in the RHD-AF population. This knowledge gap directly impairs the ability of Egyptian cardiac centers to design effective anticoagulation clinic models.16 WARDEN-Egypt addresses a precisely defined evidence gap at zero marginal cost: the study relies entirely on INR logbooks already maintained in clinical practice and structured follow-up visits that replicate current standard of care. Its findings will provide the first Egyptian TTR benchmark, identify modifiable predictors of poor anticoagulation control amenable to targeted intervention, and generate hypothesis-forming data on the TTR-outcome relationship. This has direct implications for anticoagulation clinic design, national guideline development, and future interventional trials in Egyptian RHD.

Official title: Time in Therapeutic Range, Predictors of Poor Anticoagulation Control, and Clinical Outcomes in Egyptian Patients With Rheumatic Heart Disease and Atrial Fibrillation on Warfarin: A Single Center Retrospective-Prospective Cohort Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

90

Start Date

2026-10-01

Completion Date

2028-10-01

Last Updated

2026-09-17

Healthy Volunteers

No

Conditions

AF

Interventions

DIAGNOSTIC_TEST

INR

The International Normalized Ratio is calculated from a prothrombin time (PT) blood test.It standardizes test results across different laboratories so doctors get consistent data no matter where the test is run.It evaluates how well your blood clotting system functions

DIAGNOSTIC_TEST

Time in Therapeutic Range

The International Normalized Ratio is calculated from a prothrombin time (PT) blood test.It standardizes test results across different laboratories so doctors get consistent data no matter where the test is run.It evaluates how well your blood clotting system functions

DIAGNOSTIC_TEST

International Normalized Ratio (INR)

The International Normalized Ratio is calculated from a prothrombin time (PT) blood test.It standardizes test results across different laboratories so doctors get consistent data no matter where the test is run.It evaluates how well your blood clotting system functions

Inclusion Criteria: * Inclusion Criteria 1. Age ≥18 years 2. Confirmed diagnosis of rheumatic heart disease (echocardiographic evidence of rheumatic valve morphology, prior history of rheumatic fever, or cardiology consultant diagnosis recorded in medical records) 3. Electrocardiographically or holter-confirmed atrial fibrillation (paroxysmal, persistent, or permanent) 4. On warfarin therapy for at least 6 consecutive months prior to enrollment with the intent to continue 5. At least 3 recorded INR values in the preceding 12 months in the center's logbook (minimum data requirement for Rosendaal TTR calculation) 6. Willingness to attend scheduled follow-up visits for 12 months and to provide written informed consent Exclusion Criteria: 1. Anticipated cardiac surgery, valvuloplasty, or cardioversion within the next 6 months 2. Pregnancy or planned pregnancy during the study period 3. Active malignancy or other life-limiting condition with expected survival \<12 months 4. Current or recent (≤12 months) use of a direct oral anticoagulant or heparin as primary anticoagulation 5. Severe hepatic impairment (Child-Pugh C) or known bleeding diathesis 6. Residence in a geographic area making 12-month follow-up participation unreasonably burdensome (as judged by the site investigator) 7. Fewer than 3 documented INR values in the preceding 12 months (insufficient data for Rosendaal TTR calculation) 6. Presence of a mechanical prosthetic heart valve (MPHV) in any position (aortic or mitral), regardless of thrombogenicity category. Patients with bioprosthetic (tissue) valves are not excluded, provided the prescribed INR target is 2.0-3.0 and all other inclusion criteria are met. Patients with mechanical prosthetic heart valves (MPHVs) are excluded from this study. With all enrolled patients having native RHD-AF, a uniform INR therapeutic target of 2.0-3.0 applies to every participant, eliminating patient-specific target adjustments and rendering valve type non-informative as an analytical predictor. The overwhelming majority of warfarin-treated RHD-AF patients at Assiut University Heart Hospital have rheumatic mitral stenosis as the dominant lesion, making this a clinically homogeneous and internally valid study population. Patients with bioprosthetic (tissue) valves on warfarin for AF are not excluded, provided their prescribed INR target is 2.0-3.0 and all other inclusion criteria are satisfied. \-

Locations (1)

Assiut University Heart Hospital, Assiut, Egypt

Asyut, Asyut Governorate, Egypt

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