Clinical trial NCT02865798: China Senile Valvular Heart Disease Cohort Study
Official title: Multicenter Prospective Cohort Study of Senile Hospitalized Patients With Valvular Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Valve Diseases
Keywords: Heart Valve Diseases
Cardiovascular Diseases
Heart Disease
Valvular Heart Diseases
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2016-08-12
Enrollment: 4000
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.


Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
References:
citation: 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.