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Cohort Observing Mechanisms, Progression and Sequelae of Valvular Heart Disease

ConditionsHeart Valve DiseaseMitral Valve (MV) RegurgitationMitral Valve DiseaseMitral Valve StenosisAortic Valve DiseaseAortic Valve StenosisTricuspid Valve DiseaseTricuspid Valve RegurgitationAortic Valve RegurgitationPulmonary Valve DiseaseTranscatheter Valve ReplacementTranscatheter Aortic Valve Replacement (TAVR)Transcatheter Pulmonary Valve Replacement (TPVR)Transcatheter Edge-to-edge Repair
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years old;

Be willing and able to provide informed consent to participate in the study;

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%.

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

All cause mortality

Time frame
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
2

Heart valve replacement or repair

Surgical Heart Valve Replacement/Repair or Transcatheter Aortic Valve Replacement/Repair

Time frame
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
3

Stroke

Episode of ischemic stroke or hemorrhagic stroke in the internal carotid artery territory defined on CT scan or MRI brain.

Time frame
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
4

Re-hospitalization related to cardiovascular disease

Requires rehospitalization due to cardiovascular diseases such as coronary atherosclerotic heart disease, heart failure, arrhythmia, pulmonary embolism, aortic disease, and hypertension.

Time frame
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

Secondary outcomes

1

Progression of valve stenosis or regurgitation

Progression from moderate valvular stenosis to severe stenosis, or from grade II valvular regurgitation to more severe regurgitation, as defined by the echocardiographic examination.

Time frame
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
2

Ventricular remodeling and deterioration of cardiac function

Changes in indicators such as LVEF, LVEDD, or anteroposterior diameter of the atria as defined by echocardiography

Time frame
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
3

Changes in quality of life and symptoms

NYHA functional class, six-minute walk distance, or newly developed or worsening typical symptoms

Time frame
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up
4

Newly Emerging Cardiovascular Disease and Complications

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.

Time frame
1-year, 2-year, 3-year, 4-year, and 5-year at follow-up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Army Medical Center of PLA

Collaborator

Huaxi Hospital

Collaborator

Fuwai Yunnan Cardiovascular Hospital

Collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

Collaborator

Second Xiangya Hospital of Central South University

Collaborator

Xiangya Hospital of Central South University

Collaborator

The General Hospital of Northern Theater Command

Collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborator

Fujian Provincial Hospital

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

The Affiliated Hospital of Qingdao University

Collaborator

Renmin Hospital of Wuhan University

Collaborator

The First Affiliated Hospital of Air Force Medicial University

Collaborator

Navy General Hospital, Beijing

Collaborator

Source ClinicalTrials.gov
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