Clinical trial NCT06587971: Intensive Treatment on Periodontitis in Aortic Stenosis
Official title: Intensive Treatment on Periodontitis in Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Stenosis
Periodontitis
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 920
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \&lt; 15 ml/min/1.73m² (according to the Cockcroft \&amp; 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.

Primary outcomes:
measure: Composite Major Cardiovascular Events (MACE) Endpoint
timeFrame: From enrollment to the follow-up periods at 12, 24, and 36 months.
Secondary outcomes:
measure: Aortic Valve Peak Velocity Change Endpoint
timeFrame: From enrollment to the follow-up periods at 12, 24, and 36 months.
measure: Serum Biomarker Endpoint
timeFrame: From enrollment to the follow-up periods at 12, 24, and 36 months.
measure: Periodontal Bacterial Biomarker Endpoint
timeFrame: From enrollment to the follow-up periods at 12, 24, and 36 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Erli Zhang, MD, PhD
role: STUDY_CHAIR
affiliation: China National Center for Cardiovascular Diseases
name: Erli Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: