Tracking progression and consequences of heart valve disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational cohort enrolling adults with moderate or greater valvular stenosis or Grade II or higher regurgitation across major hospitals in China. Investigators will collect clinical, laboratory, echocardiographic, CT, and MRI data and record device procedures, medications, and lifestyle changes during follow-up. A standardized dataset (JACC Adv. 2025 Apr) will be used to harmonize severity grading and measurements across sites. The goal is to identify multimodal markers that predict progression from moderate to severe disease and to characterize outcomes and treatment patterns over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least 18 years old;
* Be willing and able to provide informed consent to participate in the study;
* Patients with heart valve disease diagnosed by echocardiography who meet one of the following criteria:

  1. Grade II or higher Aortic valve regurgitation: regurgitant jet width \>3 mm, jet width / LVOT diameter ≥25%, jet cross-sectional area/LVOT cross-sectional area ≥5%, effective regurgitant orifice area (EROA) ≥0.1 cm², regurgitant volume per beat (R Vol)≥30 ml, or regurgitant fraction (RF) ≥30%.
  2. Moderate or higher aortic valve stenosis: peak velocity ≥3.0 m/s, Mean gradient ≥20 mm Hg, aortic valve area ≤1.5 cm², Indexed aortic valve area ≤0.85 cm²/m², or velocity ratio ≤0.50.
  3. Grade II or higher mitral valve regurgitation: regurgitant jet width ≥3 mm, regurgitant volume per beat ≥30 ml, regurgitant jet area/left atrial area \>30%, or effective regurgitant orifice area (EROA) ≥0.2 cm².
  4. Moderate or higher valve stenosis: valve area (specific finding) ≤1.5 cm², or mean gradient (supportive finding) ≥10.0 mmHg.
  5. Grade II or higher tricuspid valve regurgitation: regurgitant jet width ≥3 mm, proximal isovelocity surface area ≥6 mm, effective regurgitant orifice area (EROA) ≥0.2 cm², or regurgitant volume per beat ≥30 ml.
  6. Significant tricuspid valve stenosis: mean pressure gradient ≥5.0 mmHg, inflow time-velocity integral \>60 cm, T1/2 ≥190 ms, or valve area ≤1.0 cm².
  7. Grade II or higher pulmonary valve regurgitation: regurgitant jet width \>3 mm, regurgitant volume per beat ≥30 ml, regurgitant fraction ≥30%, or effective regurgitant orifice area (EROA) ≥0.1 cm².
  8. Moderate or higher Pulmonary valve stenosis: pulmonary valve transvalvular pressure gradient ≥40 mmHg, right ventricular systolic pressure ≥60 mmHg, or pulmonary valve opening \<1.5 cm².

Exclusion Criteria:

* Patients who are unwilling to accept registration and follow-up;
* Patients who cannot cooperate with information collection and follow-up due to mental illness or other conditions;
* Patients whose life expectancy is less than 12 months due to non-cardiac diseases (such as cancer, liver disease, kidney disease, or end-stage lung disease).

Where it's running

• Fujian Provincial Hospital, Affiliated to Fuzhou University
  Fuzhou, Fujian, China Recruiting
• Renmin Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Recruiting
• The General Hospital of Northern Theater Command
  Shenyang, Liaoning, China Recruiting
• The First Affiliated Hospital of Air Force Medicial University
  Xi'an, Shaanxi, China Recruiting

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.