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Registry for Longitudinal Mortality and Therapy in Patients With Heart Failure (GREARTWAL)

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ClinicalTrials.gov Identifier: NCT04062500
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Beijing Chao Yang Hospital
First Hospital of China Medical University
Yangpu District Central Hospital Affiliated to Tongji University
Xuhui Central Hospital, Shanghai
Ningbo Medical Center Lihuili Hospital
Shaanxi University of Chinese Medicine
People's Hospital of Xinjiang Uygur Autonomous Region
The First Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Heart Failure Other: Mortality and Rehospitalization rate

Detailed 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.

Study Design
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Study Type : Observational
Estimated Enrollment : 10500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry for Longitudinal Mortality and Therapy in Patients With Heart Failure (GREARTWAL Study)
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with heart failure
patients treated in the hospital for acute heart failure in China
 Other: Mortality and Rehospitalization rate
Mortality and Re-hospitalization of acute decompensated heart failure


Outcome Measures
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Primary Outcome Measures :
  1. Mortality of acute decompensated heart failure [ Time Frame: 10 years ]
    In-hospital and Annual mortality

  2. Re-hospitalization rate [ Time Frame: 10 years ]
    Re-hospitalization of acute decompensated heart failure


Biospecimen Retention:   Samples Without DNA
Human serum from enrolled patients

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients with heart failure
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062500


Contacts
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Contact: Dachun Xu, PhD 18917684045 ext +86 xdc77@tongji.edu.cn

Locations
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China, Shanghai
Shanghai Tenth People's Hospital, Tongji University Recruiting
Shanghai, Shanghai, China, 200072
Contact: Dachun Xu, MD,PhD    +86 18917684045    xdc77@tongji.edu.cn   
Contact: Yawei Xu, MD,PhD    +86 13916698181    xuyawei@tongji.edu.cn   
Sponsors and Collaborators
Shanghai 10th People's Hospital
First Affiliated Hospital, Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Beijing Chao Yang Hospital
First Hospital of China Medical University
Yangpu District Central Hospital Affiliated to Tongji University
Xuhui Central Hospital, Shanghai
Ningbo Medical Center Lihuili Hospital
Shaanxi University of Chinese Medicine
People's Hospital of Xinjiang Uygur Autonomous Region
The First Affiliated Hospital of Zhengzhou University
Investigators
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Principal Investigator: Dachun Xu, PhD Shanghai Tenthth People's Hospital
More Information
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Responsible Party: Ya-Wei Xu, MD, pHD, Director of Cardiovascular Department, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT04062500     History of Changes
Other Study ID Numbers: GREARTWAL
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ya-Wei Xu, Shanghai 10th People's Hospital:
Heart Failure,prognostic, registry
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases