Vitamin K Antagonist in Rheumatic Heart Disease Patients With Mechanical Heart Valves: Our Current Status

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAhmed Hassan Rostom Ibrahim

About this trial

VKA in RHD patients with MHV: our current status

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed presence of a mechanical heart valve.

Aged ≥18 years

Disqualifiers

Pregnancy.

Active bleeding disorders.

Severe liver/kidney disease (if affecting anticoagulation).

Trial population

Data collection: Data will be collected directly by the researcher and will be reviewed by the supervising team to ensure accuracy and consistency. The data collection process will involve recording INR observation , clinical evaluations Each participant will have their data entered into a secure database for further analysis.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Time in therapeutic range (TTR) for warfarin.

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.

Time frame
Baseline
2

2. Correlation Between TTR and Patient-Specific Factors

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.

Time frame
Baseline

Secondary outcomes

1

1. Number of Participants With Reported Bleeding Events (Major or Minor)

Presence or absence of self-reported or documented major/minor bleeding events prior to or at the time of data collection.

Time frame
Baseline
2

Number of Participants With Thromboembolic Events

History of stroke, valve thrombosis, or systemic embolism collected from medical records or patient report during the study visit.

Time frame
Baseline
3

Rate of Patient Adherence to Warfarin Therapy

Adherence assessed via patient self-report and/or pill count at the single study visit.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Ahmed Hassan Rostom Ibrahim

Lead sponsor

Assiut University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: