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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07146282
Acronym
VKA and RHD
Enrollment
165
Registered
2025-08-28
Start date
2025-09-30
Completion date
2027-10-31
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatic Heart Disease

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

Interventions

None listed

Sponsors

Ahmed Hassan Rostom Ibrahim
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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).

Design outcomes

Primary

MeasureTime frameDescription
2. Correlation Between TTR and Patient-Specific FactorsBaselineAssesses 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 in therapeutic range (TTR) for warfarin.BaselineTTR 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.

Secondary

MeasureTime frameDescription
1. Number of Participants With Reported Bleeding Events (Major or Minor)BaselinePresence or absence of self-reported or documented major/minor bleeding events prior to or at the time of data collection.
Number of Participants With Thromboembolic EventsBaselineHistory of stroke, valve thrombosis, or systemic embolism collected from medical records or patient report during the study visit.
Rate of Patient Adherence to Warfarin TherapyBaselineAdherence assessed via patient self-report and/or pill count at the single study visit.

Contacts

Primary ContactAhmed Hassan Rostom, Master
ahmedrostom112@gmail.com+201122713232

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026