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Enrolling by invitationNCT07934641Updated Nov 13, 2026

Prevalence, Risk Factors, and Clinical Outcomes of Valvular Heart Disease

An observational study in Aortic Stenosis, Aortic Regurgitation and Mitral Stenosis, sponsored by Beijing Anzhen Hospital. Enrolling by invitation at 4 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Beijing Anzhen Hospital · Observational

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 68 studies in Aortic Valve Stenosis with a site in China — 42 open to participants now, 50 under way, 3 of them phase 3. Aortic Valve Stenosis · China.

Planned enrollment
Largest of 21
12,000 · median 480
Started
2024
with 10 others
Observational
21 of 68
15 open now
Primary completion
2027-12
later than 33 of 49 live
Registered
68th of 68
by date
Lead sponsor
4 of 68
Beijing Anzhen Hospital

Among the 68 studies in Aortic Valve Stenosis with a site in China, this one has the largest planned enrollment of the 21 observational ones that give a count, is one of 11 that started in 2024, is one of 21 observational ones, reaches primary completion later than 33 of the 49 other live ones, and was the 68th registered.

Aortic Valve Stenosis

1,026 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.

Browse Aortic Valve Stenosis studies →

Open to participants now

42 of the 68 studies in Aortic Valve Stenosis with a site in China are open now. Recruiting first, the newest first:

37 more — sign in →

All 42 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 68 studies in Aortic Valve Stenosis with a site in China, or all of them as a file.
02

Study summary

This community-based observational study primarily aims to estimate the prevalence, characterize the clinical spectrum, and identify associated risk factors for moderate or greater valvular heart disease (VHD) in China. Longitudinal follow-up will characterize VHD progression and assess long-term clinical outcomes among participants.

Read the detailed description

Valvular heart disease (VHD) represents a growing public health burden in China as the population ages. However, community-based evidence on its prevalence, clinical spectrum, associated factors, disease awareness, treatment, and long-term outcomes remains limited.

This study will characterize VHD subtypes, severity, and etiology, as well as cardiac structural and functional abnormalities, in community-based Chinese populations. Awareness, treatment, and valve intervention rates will also be assessed. Data collected during previous cohort visits will be used to examine associations between cumulative risk factor exposures and moderate-to-severe VHD, while prospective follow-up will characterize disease progression and long-term clinical outcomes. The diagnostic performance of synchronous electrocardiogram-phonocardiogram (ECG-PCG) signals will be evaluated using core laboratory echocardiographic findings as the reference standard.

Eligible adults from established community-based cohorts at selected sites in China are invited to participate during the current follow-up round. All participants will undergo standardized transthoracic echocardiography and synchronous ECG-PCG recording. An independent echocardiography core laboratory reviews image quality, confirms valvular diagnoses and severity grades, and assesses cardiac structure and function. Participants will undergo lifelong follow-up from the current study assessment to ascertain all-cause and cardiovascular mortality, heart failure, valve interventions, and other cardiovascular events. Repeat echocardiography and ECG-PCG recordings will be scheduled according to cohort follow-up arrangements.

03

Conditions studied

  • Aortic Stenosis
  • Aortic Regurgitation
  • Mitral Stenosis
  • Mitral Regurgitation
  • Tricuspid Regurgitation
  • Valvular Heart Disease
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The study population is drawn from established community-based cohorts within the China-PAR (Prediction for Atherosclerotic Cardiovascular Disease Risk in China) project at selected sites in China. Data are collected through current cohort follow-up assessments and review of existing cohort and medical records.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 years or older.
  • Previous enrollment in the China-PAR cohort and participation in the current follow-up assessment.
  • Written .

Exclusion criteria

Exclusion Criteria:

- No additional disease-specific exclusion criteria.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Interventions

  • Diagnostic testTransthoracic echocardiography

    Participants will undergo standardized transthoracic echocardiography to assess valvular heart disease, as well as cardiac structure, function, and hemodynamics. Images and measurements will be acquired and stored according to a standardized protocol. A central echocardiography core laboratory will review image quality and confirm valvular disease diagnoses and severity.

  • Diagnostic testwearable synchronous electrocardiogram-phonocardiogram

    Participants will undergo noninvasive, simultaneous electrocardiogram and phonocardiogram recording using a wearable device. Signals will be acquired, stored, and assessed for quality according to a standardized protocol. Exploratory analyses will evaluate the diagnostic value of these signals in identifying and characterizing valvular heart disease and other cardiac abnormalities, using core laboratory echocardiographic findings as the reference standard.

06

What researchers measure

Primary outcomes

  1. Moderate or greater valvular heart disease

    Prevalence will be reported as the percentage of participants with at least moderate aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation, or tricuspid regurgitation. Diagnosis and severity grading will be confirmed by the echocardiography core laboratory. The presence or absence of moderate or greater valvular heart disease will be used as the outcome in risk factor analyses. Associations of demographic characteristics, cardiovascular risk factors, lifestyle and metabolic factors, and cumulative exposures with moderate-to-severe valvular heart disease will be examined using multivariable regression models.

    Time frame: Baseline

Secondary outcomes

  1. Trivial or mild valvular heart disease

    Percentage of trivial or mild valvular heart disease

    Time frame: Baseline

  2. Etiologic distribution of valvular heart disease

    Percentage of participants with moderate or greater valvular heart disease in each etiologic category. Etiology will be classified using echocardiographic findings and available clinical information.

    Time frame: Baseline

  3. Awareness of valvular heart disease

    Percentage of participants aware of their valvular heart disease before screening.

    Time frame: Baseline

  4. History of surgical or transcatheter valve intervention

    Percentage of all participants with a history of surgical or transcatheter valve intervention before screening

    Time frame: Baseline

Other outcomes

  1. All-cause mortality

    Time frame: Up to 5 years

  2. Cardiovascular mortality

    Time frame: Up to 5 years

  3. Valve intervention

    Surgical or transcatheter valve intervention during follow-up

    Time frame: Up to 5 years

  4. Heart failure hospitalization

    Unplanned hospitalization for new-onset or worsening heart failure during follow-up

    Time frame: Up to 5 years

07

Study locations

4 sites
  • Beijing Anzhen Hospital
    Beijing, Beijing Municipality 100029, China
  • Beijing Anzhen Hospital
    Luoyang, Henan, China
  • Beijing Anzhen Hospital
    Changshu, Jiangsu, China
  • Beijing Anzhen Hospital
    Jinan, Shandong, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Dec 2027, 41 months after the start.

Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 41 months is close to that.

Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2026
First posted
Nov 13, 2026
StartActual
Jul 18, 2024
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2032
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07934641
Responsible party
Guangyuan Song (Professor, Beijing Anzhen Hospital) — Principal investigator
First posted
Nov 13, 2026
Start date
Jul 18, 2024
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2032 (estimated)
Last update
Nov 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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