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Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University (VHD-ZJU)

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ClinicalTrials.gov Identifier: NCT03011697
Recruitment Status : Not yet recruiting
First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Tracking Information
First Submitted Date January 4, 2017
First Posted Date January 5, 2017
Last Update Posted Date January 5, 2017
Study Start Date January 2017
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2017)
All-cause mortality and disabling strokes [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 4, 2017)
  • Hospitalization for heart failure [ Time Frame: one year ]
  • Surgical or transcatheter aortic valve replacement [ Time Frame: one year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University
Official Title A Prospective, Single-center,Registry Study of Chinese Hospitalized Adult Patients With Valvular Heart Disease
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 10000 hospitalized patients over 18 years old with valvular heart disease will be enrolled consecutively
Condition Valvular Heart Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 4, 2017)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2027
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Liu Xianbao, MD +86-13857173887 liuxb2009@hotmail.com
Contact: Wang Jian-an, MD,PhD +86-13805786328 jian_an_wang@yahoo.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03011697
Other Study ID Numbers SAHZJU CT010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators Not Provided
Investigators
Principal Investigator: Wang Jian-an, MD,PhD Second Affiliated Hospital Zhejiang University School of Medicine
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date December 2016