Intensive Treatment on Periodontitis in Aortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- China National Center for Cardiovascular Diseases
- Enrollment
- 920
- Locations
- 1
- Primary Endpoint
- Composite Major Cardiovascular Events (MACE) Endpoint
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trial is to determine if standardized periodontal therapy can effectively slow the progression of aortic valve stenosis in adult patients diagnosed with moderate aortic valve stenosis and coexisting gingivitis or mild-to-moderate periodontitis.
The main questions it aims to answer are: Can periodontal therapy slow the progression of aortic valve stenosis? Is chronic periodontitis an independent risk factor for the accelerated progression of aortic valve stenosis? Researchers will compare a group of patients receiving standardized periodontal therapy to a control group receiving only oral hygiene education to see if periodontal treatment results in a slower progression of aortic valve stenosis.
Participants will undergo initial screening to confirm eligibility based on aortic valve peak velocity and periodontal status. They will then be randomly assigned to either the treatment group, which will receive comprehensive periodontal therapy, or the control group, which will receive only oral hygiene education. Participants will be followed up regularly over a 36-month period, with assessments including echocardiograms to monitor the progression of aortic valve stenosis, periodontal examinations to assess oral health status, and blood tests to measure relevant serum biomarkers. The study will also track any cardiovascular events and adverse events related to the interventions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 years or older.
- •Aortic valve peak velocity (Vmax) between 3.0 and 3.9 m/s.
- •Diagnosis of aortic valve stenosis identified as degenerative aortic valve stenosis.
- •Presence of gingivitis or mild-to-moderate periodontitis confirmed by periodontal probing or panoramic dental radiography.
- •Willingness to participate in the study and signing of informed consent.
Exclusion Criteria
- •End-stage renal disease with eGFR \< 15 ml/min/1.73m² (according to the Cockcroft \& Gault formula).
- •Pregnant, breastfeeding, and women of childbearing age (except those with effective contraception).
- •Factors that may affect study follow-up or adherence to periodontal therapy.
- •Patients unwilling or unable to undergo comprehensive periodontal treatment.
- •Patients who do not consent to participate in the study.
Outcomes
Primary Outcomes
Composite Major Cardiovascular Events (MACE) Endpoint
Time Frame: From enrollment to the follow-up periods at 12, 24, and 36 months.
Composite Major Cardiovascular Events (MACE), including: 1. Hospitalization or emergency/outpatient visits due to heart failure. 2. Hospitalization or emergency/outpatient visits due to angina. 3. Hospitalization or emergency/outpatient visits due to syncope. 4. Cardiovascular death. 5. Undergoing interventional or surgical valve replacement. 6. Non-fatal myocardial infarction. 7. Undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). 8. Ischemic stroke.
Secondary Outcomes
- Aortic Valve Peak Velocity Change Endpoint(From enrollment to the follow-up periods at 12, 24, and 36 months.)
- Serum Biomarker Endpoint(From enrollment to the follow-up periods at 12, 24, and 36 months.)
- Periodontal Bacterial Biomarker Endpoint(From enrollment to the follow-up periods at 12, 24, and 36 months.)