Registry of Valvular Heart Disease in Hospitalized Adults in China

A Prospective, Single-center,Registry Study of Chinese Hospitalized Adult Patients With Valvular Heart Disease

This study is trying to gather information about adults in China who are hospitalized with valvular heart disease to better understand how common it is, how it's treated, and what the outcomes are.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT03011697 on ClinicalTrials.gov

What this trial studies

This observational cohort study aims to gather contemporary data on the prevalence, characteristics, risk stratification, cost-effectiveness, treatments, and prognosis of hospitalized adult patients with valvular heart disease in China. Given the increasing frequency of valvular heart disease, particularly among the aging population, this study seeks to address the gaps in understanding its impact in developing countries. By focusing on hospitalized patients over 18 years old with moderate or severe valvular conditions, the study will provide valuable insights into the management and outcomes of this patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized adults over 18 years old with moderate or severe valvular heart disease as defined by echocardiographic criteria.

Not a fit: Patients with mild valvular heart disease or those not hospitalized may not receive benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding and treatment of valvular heart disease in Chinese patients, leading to improved patient outcomes.

How similar studies have performed: While similar studies have been conducted, this specific observational cohort approach focusing on the Chinese population is relatively novel.

Eligibility criteria

Inclusion Criteria:

Hospitalized patients over 18 years old meet one of the following conditions.

1. moderate or above valvular heart disease as defined by echocardiography: 1.1 Aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg, 1.2 Aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, 1.3 Mitral stenosis, moderate or above, or valve area ≤2.0cm2, 1.4 Mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, 1.5 Tricuspid stenosis, moderate or above, or valve area ≤1.0cm2, 1.6 Tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2, 1.7 Pulmonic stenosis, moderate or above, or maximal jet velocity \>4m/sec, 1.8 Pulmonic regurgitation, moderate or above,
2. Patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
3. Diagnosis of endocarditis as assessed by Duke criteria.

Exclusion Criteria:

1. Patients cannot be followed up for any reasons.
2. Patients in critical condition may be die in one year.
3. Patients have been enrolled in this study.

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine at Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Wang Jian-an, MD,PhD — Second Affiliated Hospital Zhejiang University School of Medicine
• Study coordinator: Liu Xianbao, MD

Conditions Valvular Heart Disease