NCT02865798

Brief Summary

Valvular heart diseases (VHD) are the most common causes of mortality and morbidity after coronary artery disease, hypertension, and heart failure, especially in senile patients who have more comorbidities and often require intervention. The prevalence of senile VHD is increased gradually as the growth of the age. In addition important changes have occurred as regards the presentation and treatment of the disease over recent years. However, there is little information about senile VHD in China. The purposes of this study are to evaluate the clinical characteristics, reasons for hospitalization, risk stratification, treatment modalities, quality of life and outcomes of senile hospitalized patients with VHD, to determine the risk factors affecting the prognosis, further to lay the foundation for establishing a prognosis model suitable for Chinese senile VHD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

August 10, 2016

Last Update Submit

August 10, 2016

Conditions

Heart Valve Diseases

Keywords

Heart Valve DiseasesCardiovascular DiseasesHeart DiseaseValvular Heart Diseases

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    one year

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In 71 hospitals have capable of valvular surgery in China, 4000 hospitalized patients over 60 years old with valvular heart disease will be enrolled consecutively.

You may qualify if:

  • Hospitalized patients over 60 years old meet one of the following conditions.
  • moderate or above valvular heart disease as defined by echocardiography:
  • aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg,
  • aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
  • mitral stenosis, moderate or above, or valve area ≤2.0cm2,
  • mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%,
  • tricuspid stenosis, moderate or above, or valve area ≤1.0cm2,
  • tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2,
  • pulmonic stenosis, moderate or above, or maximal jet velocity \>4m/sec,
  • pulmonic regurgitation, moderate or above,
  • or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
  • or 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 the near future.
  • Patients have been enrolled in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

Related Publications (1)

  • Zhao Q, Xu H, Liu Q, Ye Y, Zhang B, Li Z, Gao R, Wu Y. Therapeutic Decision-Making and Outcomes in Elderly Patients With Severe Symptomatic Aortic Stenosis: Prognostic Implications of Elderly Patients' Initial Decisions. Front Cardiovasc Med. 2021 Jul 26;8:696763. doi: 10.3389/fcvm.2021.696763. eCollection 2021.

    PMID: 34381825DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A 6mL whole blood sample is collected in an EDTA vacuum tube.

MeSH Terms

Conditions

Heart Valve DiseasesCardiovascular DiseasesHeart Diseases

Central Study Contacts

Yongjian Wu, M.D., Ph.D.

CONTACT

0086-10-88396780fuwaihospital@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 12, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 12, 2016

Record last verified: 2016-08

Locations

CN(1)