NCT07146282Not yet recruitingNot Applicable
Vitamin K Antagonist in Rheumatic Heart Disease Patients With Mechanical Heart Valves: Our Current Status
Ahmed Hassan Rostom Ibrahim0 sites165 target enrollmentStarted: September 1, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 165
- Primary Endpoint
- Time in therapeutic range (TTR) for warfarin.
Study Overview
Brief Summary
VKA in RHD patients with MHV: our current status
Detailed Description
Vitamin K Antagonist in Rheumatic heart disease patients with mechanical heart valves: Our Current Status
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed presence of a mechanical heart valve.
- •Aged ≥18 years
Exclusion Criteria
- •Pregnancy.
- •Active bleeding disorders.
- •Severe liver/kidney disease (if affecting anticoagulation).
Outcomes
Primary Outcomes
Time in therapeutic range (TTR) for warfarin.
Time Frame: Baseline
TTR status will be calculated using the most recent INR value and patient records to determine whether INR is within the target therapeutic range (2.0-3.5) at the time of data collection.
2. Correlation Between TTR and Patient-Specific Factors
Time Frame: Baseline
Assesses the relationship between INR control and factors such as age, comorbidities, adherence, vitamin K intake, and medication use based on data collected at the single study visit.
Secondary Outcomes
- 1. Number of Participants With Reported Bleeding Events (Major or Minor)(Baseline)
- Number of Participants With Thromboembolic Events(Baseline)
- Rate of Patient Adherence to Warfarin Therapy(Baseline)
Investigators
Ahmed Hassan Rostom Ibrahim
principal investigator
Assiut University
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