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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04062500
Other study ID # GREARTWAL
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2027

Study information

Verified date August 2020
Source Shanghai 10th People's Hospital
Contact Dachun Xu, PhD
Phone 18917684045
Email xdc77@tongji.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this registry is to compile a large clinical database on the medical management of patients hospitalized with acute heart failure, using information collected from hospitals across China.


Description:

Registry for Longitudinal mortality and therapy in patients with Heart Failure is a large, multicenter, prospective, open-label registry of the management of patients treated in the hospital for acute heart failure in China. The objective of this study is to investigate the clinical features and prognosis of patients with heart failure, and discover the characteristics of high-risk heart failure patients, and elucidate critical factors which predict the development and outcomes of symptomatic heart failure patients.

1. To elucidate the clinical characteristics and prognostic risks of patients with heart failure.

2. To study the characteristics of high-risk heart failure patients and predict the key factors for the development of symptomatic heart failure patients.

3. To elucidate the compliance of patients with heart failure and the incidence of adverse drug effects.

4. To investigate the effect of self-management on outcomes in patients with heart failure.

5. To elucidate critical factors associated with the development and outcomes of heart failure.

6. To investigate hospitalization expenses for heart failure.


Recruitment information / eligibility

Status Recruiting
Enrollment 10500
Est. completion date December 31, 2027
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- 1. 18 years and older. 2. Meet the diagnostic criteria of China 2018 or JACC/AHA 2017 or ESC 2016 heart failure guidelines.

3. Agree to be tested and sign an informed consent certificate.

Exclusion Criteria:

- 1. Age<18 years old. 2. Patients who refused to participate. 3. Patients may have a life expectancy of less than 1 years due to non- heart failure clinical conditions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mortality and Rehospitalization rate
Mortality and Re-hospitalization of acute decompensated heart failure

Locations

Country Name City State
China Shanghai Tenth People's Hospital, Tongji University Shanghai Shanghai

Sponsors (11)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital Beijing Chao Yang Hospital, First Affiliated Hospital, Sun Yat-Sen University, First Hospital of China Medical University, Nanfang Hospital of Southern Medical University, Ningbo Medical Center Lihuili Hospital, People's Hospital of Xinjiang Uygur Autonomous Region, Shaanxi University of Chinese Medicine, The First Affiliated Hospital of Zhengzhou University, Xuhui Central Hospital, Shanghai, Yangpu District Central Hospital Affiliated to Tongji University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality of acute decompensated heart failure In-hospital and Annual mortality 10 years
Primary Re-hospitalization rate Re-hospitalization of acute decompensated heart failure 10 years
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