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Not yet recruiting NCT07146282

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

— Observational Rheumatic Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Rheumatic Heart Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Primary outcome measures

  • Time in therapeutic range (TTR) for warfarin. [Time frame: Baseline]
  • 2. Correlation Between TTR and Patient-Specific Factors [Time frame: Baseline]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 28834488
  • 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 37327912
  • 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 35210036
  • 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 38404722

Identifiers

NCT: NCT07146282 · VKA in RHD current status

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗