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A Clinical Follow-up Study of Heart Failure Patients.

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ClinicalTrials.gov Identifier: NCT03797742
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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Brief Summary:
Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.

Condition or disease
Heart Failure

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Clinical Follow-up Study of Heart Failure Patients.
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
NC
Patients without heart failure.
DCM
Dilated cardiomyopathy patients.
ICM
Ischemic cardiomyopathy patients.


Outcome Measures
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Primary Outcome Measures :
  1. NYHA functional class [ Time Frame: one year after enrolled ]
    NYHA cardiac functional class

  2. All-cause mortality [ Time Frame: one year after enrolled ]
    All-cause mortality during follow-up


Secondary Outcome Measures :
  1. hospitalization for cardiac causes [ Time Frame: one year after enrolled ]
    hospitalization for cardiac causes during follow-up

  2. left ventricular end-diastolic dimension(LVEDD) dilates. [ Time Frame: one year after enrolled ]
    left ventricular structure changes:left ventricular end-diastolic dimension(LVEDD) dilates.

  3. left ventricular ejection fraction reduces [ Time Frame: one year after enrolled ]
    left ventricular function changes:left ventricular ejection fraction reduces


Biospecimen Retention:   Samples With DNA
Serum; Whole blood

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The inpatient in the department of cardiology of Zhongshan Hospital, Fudan University will be selected.
Criteria

Inclusion Criteria:

  • LVEF≤ 55%
  • enlarged left ventricular end-diastolic dimension
  • ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels.
  • symptomatic heart failure

Exclusion Criteria:

  • Known malignant tumour diseases
  • Pregnancy or lactation period；
  • Investigators think not suitable to participate in this trial.
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): NCT03797742


Contacts
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Contact: Zhangwei Chen +86 021 64041990 chen.zhangwei@zs-hospital.sh.cn

Locations
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China
Zhongshan Hospital Recruiting
Shanghai, China
Contact: Zhangwei Chen    +8602164041990    chen.zhangwei@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03797742    
Other Study ID Numbers: HF201801
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases