Rheumatic Heart DiseaseVKA and RHDNCT07146282
Vitamin K Antagonist in Rheumatic Heart Disease Patients With Mechanical Heart Valves: Our Current Status
An observational study of Rheumatic Heart Disease, run by Ahmed Hassan Rostom Ibrahim.
Trial summary
VKA in RHD patients with MHV: our current status Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Heart Disease
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Confirmed presence of a mechanical heart valve.
- Aged ≥18 years
Who cannot join
- Pregnancy.
- Active bleeding disorders.
- Severe liver/kidney disease (if affecting anticoagulation).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
VKA in RHD patients with MHV: our current status
Read the detailed description
Vitamin K Antagonist in Rheumatic heart disease patients with mechanical heart valves: Our Current Status
- Conditions
- Rheumatic Heart Disease
- Medical subject headings
- Rheumatic Heart Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Baseline
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.
Measured: Baseline
Rate of Patient Adherence to Warfarin Therapy
Adherence assessed via patient self-report and/or pill count at the single study visit.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rheumatic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Hassan Rostom Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Hassan Rostom Ibrahim, Assiut University
- Investigators
- Hamdy Shams Mohamed, Principal investigatorTarek hameed Nageeb, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146282
- Sponsor's protocol ID
- VKA in RHD current status
- Acronym
- VKA and RHD
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
PubMed 28834488Beckmann A, Meyer R, Lewandowski J, Markewitz A, Blassfeld D, Boning A. German Heart Surgery Report 2022: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg. 2023 Aug;71(5):340-355. doi: 10.1055/s-0043-1769597. Epub 2023 Jun 16.
PubMed 37327912El-Hamamsy I, Toyoda N, Itagaki S, Stelzer P, Varghese R, Williams EE, Erogova N, Adams DH. Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults. J Am Coll Cardiol. 2022 Mar 1;79(8):805-815. doi: 10.1016/j.jacc.2021.11.057.
PubMed 35210036Zilla P, Human P, Pennel T. Mechanical valve replacement for patients with rheumatic heart disease: the reality of INR control in Africa and beyond. Front Cardiovasc Med. 2024 Feb 9;11:1347838. doi: 10.3389/fcvm.2024.1347838. eCollection 2024.
PubMed 38404722
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin K Antagonist in Rheumatic Heart Disease Patients With Mechanical Heart Valves: Our Current Status
- ClinicalTrials.gov ID
- NCT07146282
- Acronym / sponsor ID
- VKA and RHD / VKA in RHD current status
- Conditions
- Rheumatic Heart Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Ahmed Hassan Rostom IbrahimUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- Confirmed presence of a mechanical heart valve.
- Aged ≥18 years
Key exclusion criteria (3 listed)
- Pregnancy.
- Active bleeding disorders.
- Severe liver/kidney disease (if affecting anticoagulation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
1. Number of Participants With Reported Bleeding Events (Major or Minor)
Time frame: Baseline
Number of Participants With Thromboembolic Events
Time frame: Baseline
Rate of Patient Adherence to Warfarin Therapy
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 28834488Watkins DA, Johnson CO, Colquhoun SM, Karthikeyan G, Beaton A, Bukhman G, Forouzanfar MH, Longenecker CT, Mayosi BM, Mensah GA, Nascimento BR, Ribeiro ALP, Sable CA, Steer AC, Naghavi M, Mokdad AH, Murray CJL, Vos T, Carapetis JR, Roth GA. Global, Regional, and National Burden of Rheumatic Heart Disease, 1990-2015. N Engl J Med. 2017 Aug 24;377(8):713-722. doi: 10.1056/NEJMoa1603693.
- Background: PubMed 37327912Beckmann A, Meyer R, Lewandowski J, Markewitz A, Blassfeld D, Boning A. German Heart Surgery Report 2022: The Annual Updated Registry of the German Society for Thoracic and Cardiovascular Surgery. Thorac Cardiovasc Surg. 2023 Aug;71(5):340-355. doi: 10.1055/s-0043-1769597. Epub 2023 Jun 16.
- Background: PubMed 35210036El-Hamamsy I, Toyoda N, Itagaki S, Stelzer P, Varghese R, Williams EE, Erogova N, Adams DH. Propensity-Matched Comparison of the Ross Procedure and Prosthetic Aortic Valve Replacement in Adults. J Am Coll Cardiol. 2022 Mar 1;79(8):805-815. doi: 10.1016/j.jacc.2021.11.057.
- Background: PubMed 38404722Zilla P, Human P, Pennel T. Mechanical valve replacement for patients with rheumatic heart disease: the reality of INR control in Africa and beyond. Front Cardiovasc Med. 2024 Feb 9;11:1347838. doi: 10.3389/fcvm.2024.1347838. eCollection 2024.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamdy Shams Mohamed principal investigator
Tarek hameed Nageeb principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Heart Disease, run by Ahmed Hassan Rostom Ibrahim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hassan Rostom, Master (+201122713232 ext. +201064030397, ahmedrostom112@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in therapeutic range (TTR) for warfarin. (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07146282, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.