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NCT Number: NCT07146282

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

VKA in RHD patients with MHV: our current status

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Key information

Conditions

Rheumatic Heart Disease Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Gram-Positive Bacterial Infections Heart Diseases Infections Rheumatic Fever Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Vitamin K Antagonist in Rheumatic heart disease patients with mechanical heart valves: Our Current Status

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

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

  2. Number of Participants With Thromboembolic Events

    Time frame: Baseline

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

  3. Rate of Patient Adherence to Warfarin Therapy

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Hassan Rostom, Master

CONTACT

[email protected]

+201122713232 ext. +201064030397

Sponsors and collaborators

Lead sponsor

Ahmed Hassan Rostom Ibrahim

Other

Registry information

Acronym: VKA and RHD

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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