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

November 25, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

The objective of this study is to evaluate and predict the progression of moderate cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, computed tomography (CT), and magnetic resonance imaging (MRI) data. Additionally, the study aims to analyze the potential impact of device-based interventions, pharmacological therapy, and lifestyle modifications on disease progression.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is a prospective observational cohort study designed to investigate the disease progression, medication and surgical intervention patterns, outcomes, and influencing factors in patients with moderate or greater cardiac valve stenosis and Grade II or higher cardiac valve regurgitation. The study population includes patients diagnosed at 15 major medical institutions in China, including the Second Affiliated Hospital of Zhejiang University School of Medicine and West China Hospital of Sichuan University. The severity of valvular heart disease is determined according to a standardized dataset (JACC Adv. 2025 Apr) developed by a joint task force comprising multiple international societies.

Currently, there is a lack of clear consensus regarding the management of patients with moderate valvular stenosis and regurgitation, and their subsequent disease progression remains poorly understood. Notably, the time span for progression from moderate to severe valvular heart disease can vary from 1 to 10 years, and monitoring and early warning mechanisms for potential early markers indicating disease deterioration are currently underdeveloped. Furthermore, patients with severe valvular heart disease may experience different outcomes following various device implantations, and the associated risk factors require further clarification.

The objective of this study is to identify all clinical, biological, echocardiographic, and imaging parameters that may increase the risk of disease progression or adverse outcomes through a prospective observational cohort design. The confirmation of these parameters will guide future research in developing pharmacological and interventional treatment strategies to reduce mortality associated with this disease. Patients enrolled in this study will undergo annual outpatient follow-up visits after diagnosis, which will include electrocardiography, echocardiography, blood analysis, and contrast-enhanced CT scans. Through these comprehensive monitoring methods, we aim to accurately assess changes in patients' conditions and provide a scientific basis for clinical decision-making.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Chinese Academy of Medical Sciences, Fuwai Hospital
        • Contact:
      • Beijing, China
        • Recruiting
        • Navy General Hospital, Beijing
        • Contact:
      • Chongqing, China, 400010
        • Recruiting
        • Army Medical Center of PLA
        • Contact:
      • Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Provincial Hospital, Affiliated to Fuzhou University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin Hospital of Wuhan University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China
        • Recruiting
        • Second Xiangya Hospital of Central South University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110031
        • Recruiting
        • The General Hospital of Northern Theater Command
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • The First Affiliated Hospital of Air Force Medicial University
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Recruiting
        • Affiliated Hospital of Qingdao University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Huaxi Hospital
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Recruiting
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • Fuwai Yunnan Cardiovascular Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Second Affiliated Hospital of Zhejiang University, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study is a prospective observational cohort study designed to investigate the disease progression, medication and surgical intervention patterns, outcomes, and influencing factors in patients with moderate or greater cardiac valve stenosis and Grade II or higher cardiac valve regurgitation. The study population includes patients diagnosed at 15 major medical institutions in China, including the Second Affiliated Hospital of Zhejiang University School of Medicine and West China Hospital of Sichuan University. The severity of valvular heart disease is determined according to a standardized dataset (JACC Adv. 2025 Apr) developed by a joint task force comprising multiple international societies.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Heart valve replacement or repair
Time Frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Surgical Heart Valve Replacement/Repair or Transcatheter Aortic Valve Replacement/Repair
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Stroke
Time Frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Re-hospitalization related to cardiovascular disease
Time Frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Requires rehospitalization due to cardiovascular diseases such as coronary atherosclerotic heart disease, heart failure, arrhythmia, pulmonary embolism, aortic disease, and hypertension.
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression of valve stenosis or regurgitation
Time Frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Progression from moderate valvular stenosis to severe stenosis, or from grade II valvular regurgitation to more severe regurgitation, as defined by the echocardiographic examination.
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Ventricular remodeling and deterioration of cardiac function
Time Frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Changes in indicators such as LVEF, LVEDD, or anteroposterior diameter of the atria as defined by echocardiography
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Changes in quality of life and symptoms
Time Frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
NYHA functional class, six-minute walk distance, or newly developed or worsening typical symptoms
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Newly Emerging Cardiovascular Disease and Complications
Time Frame: 1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
Such as newly onset arrhythmic events (including atrial fibrillation/flutter, conduction block, sick sinus syndrome, etc.), non-hospitalized heart failure-related events, bleeding events, thrombotic events, hypertensive emergencies, and symptoms related to myocardial ischemia.
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Xiangya Hospital of Central South University
The Affiliated Hospital of Qingdao University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
People's Hospital of Xinjiang Uygur Autonomous Region
Renmin Hospital of Wuhan University
Chinese Academy of Medical Sciences, Fuwai Hospital
Second Xiangya Hospital of Central South University
Navy General Hospital, Beijing
Fujian Provincial Hospital
Huaxi Hospital
Fuwai Yunnan Cardiovascular Hospital
The General Hospital of Northern Theater Command
The First Affiliated Hospital of Air Force Medicial University
Army Medical Center of PLA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

May 31, 2030

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-0528

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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