NCT07146282

Brief Summary

VKA in RHD patients with MHV: our current status

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Sep 2025Oct 2027

First Submitted

Initial submission to the registry

August 4, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

August 4, 2025

Last Update Submit

August 21, 2025

Conditions

Rheumatic Heart Disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline

Secondary Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Confirmed presence of a mechanical heart valve.
  • Aged ≥18 years

You may not qualify if:

  • Pregnancy.
  • Active bleeding disorders.
  • Severe liver/kidney disease (if affecting anticoagulation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 28834488BACKGROUND

  • Beckmann 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.

    PMID: 37327912BACKGROUND

  • El-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.

    PMID: 35210036BACKGROUND

  • Zilla 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.

    PMID: 38404722BACKGROUND

Related Links

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic FeverStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular Diseases

Study Officials

  • Hamdy Shams Mohamed

    PRINCIPAL INVESTIGATOR

  • Tarek hameed Nageeb

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Hassan Rostom, Master

CONTACT

+201122713232ahmedrostom112@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 4, 2025

First Posted

August 28, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

August 28, 2025

Record last verified: 2025-08