Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University

NCT ID: NCT03011697

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-01

Study Completion Date

2027-12-31

Brief Summary

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We design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification,cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with valvular heart disease.

Detailed Description

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Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of VHD, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe valvular diseases are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification,cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with valvular heart disease.

Conditions

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Valvular Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Jian'an Wang,MD,PhD

President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wang Jian-an, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital Zhejiang University School of Medicine

Locations

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2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liu Xianbao, MD

Role: CONTACT

+86-13857173887

Wang Jian-an, MD,PhD

Role: CONTACT

+86-13805786328

Facility Contacts

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Liu Xianbao, MD

Role: primary

+86-13857173887

Wang Jian-an, MD,PhD

Role: backup

+86-13805786328

References

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Hu P, Liu XB, Liang J, Zhu QF, Pu CX, Tang MY, Wang JA. A hospital-based survey of patients with severe valvular heart disease in China. Int J Cardiol. 2017 Mar 15;231:244-247. doi: 10.1016/j.ijcard.2016.11.301. Epub 2016 Nov 25.

Reference Type BACKGROUND
PMID: 27908608 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/27908608

hospital-based survey of patients with severe valvular heart disease in China

Other Identifiers

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SAHZJU CT010

Identifier Type: -

Identifier Source: org_study_id

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