Abnormal function of cardiac mechanical valve
Conditions
Interventions
Traditional control group:Traditional treatment group: Maintain the original warfarin treatment, adjust the dose of warfarin, control the INR between 2.2-3.0, and adjust the oral time of warfarin to 4
Heparin treatment group:The intensity of adding heparin needs to gradually decrease, that is, first maintain the use of warfarin, INR between 1.6-2.0, and at the same time add low molecular weight hep
After the mechanical valve flow rate returns to the normal range, continue to use warfarin and maintain an INR between 1.8-2.5. At the same time, subcutaneous injection of low molecular weight heparin
And transition to subcutaneous injection of low molecular weight heparin every other day.
Sponsors
Northern Theater Command General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study focuses on patients with increased flow velocity of mechanical heart valves found during follow-up after cardiac surgery. Patients who have undergone valve replacement surgery for more than one year, regardless of gender or age, will be included. Meets the diagnostic criteria for mechanical valve dysfunction in the mitral and aortic valve positions (2024 version of the Cardiovascular Imaging Assessment Guidelines for Artificial Valve Function).
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Due to the fact that the right ventricle belongs to the low-pressure system, patients with mechanical valve dysfunction of the tricuspid valve need to be excluded; 2. Heparin therapy is contraindicated for patients with heparin allergy, spontaneous bleeding tendency, delayed blood coagulation (such as hemophilia, purpura, thrombocytopenia), ulcer disease, trauma, postpartum hemorrhage, and severe liver dysfunction; 3. The following patients should be used with caution and monitored carefully (as allergic reactions or bleeding may occur): those with a history of allergies; Individuals with bleeding tendencies and coagulation mechanism disorders, such as gastric and duodenal ulcers, stroke, severe liver and kidney diseases, severe hypertension, retinal vascular disease, threatened miscarriage; Those who have taken sufficient oral anticoagulants. This product is not suitable for use as an anticoagulant during extracorporeal circulation surgery; 4. Patients with thrombocytopenia need to undergo bone marrow puncture to determine the cause and receive specialized consultation to determine whether heparin treatment is feasible; 5. Patients with a history of thrombocytopenia after using heparin; 5. Patients with severe renal impairment (creatinine clearance rate less than 20ml/min); 6. Lactating women; 7. Complex congenital heart disease patients; 8. Patients with LVEF<0.35; 9. Combining factors such as pneumothorax and chest trauma that affect the quality of ultrasound imaging; 10. I am currently participating in another interventional clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean transvalvular pressure gradient of mechanical valve forward blood flow after 3 months of intensified anticoagulant therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Strengthen anticoagulant therapy for two weeks, one month, two months, three months, and six months to measure the effective orifice area of the mechanical valve;Strengthen anticoagulant therapy for two weeks, one month, two months, three months, and six months to measureDoppler flow velocity index (VTILVOT/VTI artificial valve for aortic valve, VTI artificial valve/VTIVOT for mitral valve);Strengthen anticoagulant therapy for two weeks, one month, two months, three months, and six months to measure pulmonary artery systolic pressure;Strengthen anticoagulant therapy for two weeks, one month, two months, three months, and six months to measure left atrial anterior posterior diameter;Strengthen anticoagulant therapy for two weeks, one month, two months, three months, and six months to measure left ventricular end diastolic diameter;Strengthen anticoagulant therapy for two weeks, one month, two months, three months, and six months to measure left ventricular diastolic function grading;Strengthen anticoagulant therapy for two weeks, one month, two months, three months, and six months to measure left ventricular global longitudinal strain; | — |
Countries
China
Contacts
Public ContactJin Yan
Northern Theater Command General Hospital of the Chinese People's Liberation Army
Outcome results
None listed