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

NCT03011697 | Recruiting DMC

• 1 other identifier: SAHZJU CT010
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

• All-cause mortality and disabling strokes

  All-cause mortality and disabling strokes

  one year

Secondary Outcomes (2)

• Hospitalization for heart failure

  one year

• Surgical or transcatheter aortic valve replacement

  one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10000 hospitalized patients over 18 years old with valvular heart disease will be enrolled consecutively

You may qualify if:

• Hospitalized patients over 18 years old meet one of the following conditions.
• 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,
• Patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
• Diagnosis of endocarditis as assessed by Duke criteria.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine at Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 27908608 BACKGROUND

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Wang Jian-an, MD,PhD

  Second Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu Xianbao, MD

CONTACT

+86-13857173887; liuxb2009@hotmail.com

Wang Jian-an, MD,PhD

CONTACT

+86-13805786328; jian_an_wang@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: February 1, 2017
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

CN (1)