Tracking progression and consequences of heart valve disease

Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease (VALVE-COMPASS)

This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 15 sites (Fuzhou, Fujian and 14 other locations)
• Trial ID: NCT07267117 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18 years) with echocardiography-confirmed moderate or greater valve stenosis or Grade II or higher valve regurgitation who can provide informed consent and attend follow-up at a participating center.

Not a fit: Patients with only mild valve disease below the enrollment thresholds, those needing immediate surgery, or individuals unable to complete serial imaging and follow-up visits are unlikely to receive direct benefit from participation.

Why it matters

Potential benefit: If successful, clinicians could identify patients at higher risk of rapid valve deterioration and tailor monitoring or timely interventions to reduce complications.

How similar studies have performed: Prior multicenter imaging cohorts have identified individual risk markers for valve disease, but comprehensive multimodal prediction of progression from moderate disease is not yet well validated.

Eligibility criteria

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 this trial is running

Fuzhou, Fujian and 14 other locations

• 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)
• Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (RECRUITING)
• Huaxi Hospital — Chengdu, Sichuan, China (RECRUITING)
• People's Hospital of Xinjiang Uygur Autonomous Region — Ürümqi, Xinjiang, China (RECRUITING)
• Fuwai Yunnan Cardiovascular Hospital — Kunming, Yunnan, China (RECRUITING)
• Second Affiliated Hospital of Zhejiang University, School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
• Chinese Academy of Medical Sciences, Fuwai Hospital — Beijing, China (RECRUITING)
• Navy General Hospital, Beijing — Beijing, China (RECRUITING)
• Army Medical Center of PLA — Chongqing, China (RECRUITING)
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (RECRUITING)

Conditions: Heart Valve Disease, Mitral Valve Regurgitation, Mitral Valve Disease, Mitral Valve Stenosis, Aortic Valve Disease, Aortic Valve Stenosis, Tricuspid Valve Disease, Tricuspid Valve Regurgitation