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.
Inclusion Criteria
Age ≥18 years
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)
Electrocardiographically or holter-confirmed atrial fibrillation (paroxysmal, persistent, or permanent)
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.
: 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.
Cohort
Other
INR
Diagnostic testThe 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
Time in Therapeutic Range
Diagnostic testThe 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
International Normalized Ratio (INR)
Diagnostic testThe 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
Primary Endpoints: (1) Mean TTR by Rosendaal linear interpolation; (2) Predictors of poor TTR (TTR <65%)
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