A Real World Study of Valvular Heart Disease in Jiangxi Province
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,052
- Locations
- 1
- Primary Endpoint
- Primary endpoints
Study Overview
Brief Summary
Study Title: A real-world study of valvular heart disease in Jiangxi Province
Research Objectives:
① Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal treatment model" for patients with valvular heart disease, and to manage the collection of diagnostic, therapeutic and prognostic data on patients.
② Secondary objective: To investigate the composite of all-cause mortality, disabling stroke, permanent pacemaker implantation, and moderate or greater valve regurgitation in the "Formal treatment model" group and the "Conventional treatment model" group. The Conventional group was matched to patients who were not in the " Formal treatment model " during the same period.
Design type: a prospective, observational, real-world study (at least 1.5 years). No pre-established fixed treatment protocols, only a Formal treatment model,with all treatment choices made entirely by clinicians following relevant textbooks, expert consensus on clinical guidelines, and based on the patient's condition.
Subjects: All patients with moderate to severe heart valve disease were collected from the Second Affiliated Hospital of Nanchang University and hospitals at all levels in Jiangxi Province from September 2022 to September 2023.
Detailed Description
Summary of Research Protocol:
Study Title: A Real World Study of Valvular Heart Disease in Jiangxi Province
Research Objectives:
① Main objectives: To examine the current incidence of valvular heart disease in Jiangxi Province, to establish a "Formal treatment model" for patients with valvular heart disease, and to manage the collection of diagnostic, therapeutic and prognostic data on patients.
② Secondary objective: To investigate the composite of all-cause mortality, disabling stroke, permanent pacemaker implantation, and moderate or greater valve regurgitation in the "Formal treatment model" group and the "Conventional treatment model" group. The Conventional group was matched to patients who were not in the " Formal treatment model " during the same period.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •All moderate-to-severe heart valve disease, including aortic, mitral, and tricuspid valves;
- •Comply with the ESC/EACTS Guidelines for the Management of Valvular Heart Disease (2021) indications for surgery for valvular heart disease;
- •Understand and voluntarily sign the informed consent form
Exclusion Criteria
- •those with severe mental disorders and unable to express their will;
- •those with obvious other abnormal signs, laboratory tests and clinical diseases that, in the judgment of the investigator, make them unsuitable for participation in the study;
- •those who, in the judgment of the investigator, are unable to complete long-term follow-up.
Outcomes
Primary Outcomes
Primary endpoints
Time Frame: 1 year after surgery or treatment
all-cause mortality, disabling stroke, and incidence of cardiogenic stroke, permanent pacemaker implantation rate, and moderate or greater valve regurgitation at 1 year after surgery or discharge from treatment
Secondary Outcomes
- NYHA classification(30 days and 1 year after discharge after surgery or treatment)
- incidence of stroke(30 days after discharge from hospital after surgery or treatment)
- Moderate or higher valvular regurgitation(immediately after the surgery or 30 days after discharge)
- The incidence of intraoperative temporary valve size replacement(intraoperative)
- The incidence of abnormal valve position(during operation)
- rate of permanent pacemaker implantation(surgery or 30 days after treatment)
- The incidence of implantation of two or more valves(during aortic valve replacement)
- The Barthel index(30 days and 1 year after surgery or treatment)
- All-cause mortality(surgery or 30 days after treatment)
- Readmission rates for aortic stenosis and/or valve implantation-related complications(30 days and 1 year after surgery or treatment)
Investigators
Xiao Huang
Principal Investigator
Second Affiliated Hospital of Nanchang University