A Clinical Follow-up Study of Heart Failure Patients.
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedFirst Submitted
Initial submission to the registry
January 1, 2019
CompletedFirst Posted
Study publicly available on registry
January 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJanuary 9, 2019
January 1, 2019
4.9 years
January 1, 2019
January 8, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
NYHA functional class
NYHA cardiac functional class
one year after enrolled
All-cause mortality
All-cause mortality during follow-up
one year after enrolled
Secondary Outcomes (3)
hospitalization for cardiac causes
one year after enrolled
left ventricular end-diastolic dimension(LVEDD) dilates.
one year after enrolled
left ventricular ejection fraction reduces
one year after enrolled
Study Arms (3)
NC
Patients without heart failure.
DCM
Dilated cardiomyopathy patients.
ICM
Ischemic cardiomyopathy patients.
Eligibility Criteria
The inpatient in the department of cardiology of Zhongshan Hospital, Fudan University will be selected.
You may qualify if:
- 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
You may not qualify if:
- Known malignant tumour diseases
- Pregnancy or lactation period；
- Investigators think not suitable to participate in this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Hospital
Shanghai, China
Biospecimen
Serum; Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 1, 2019
First Posted
January 9, 2019
Study Start
January 1, 2018
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
January 9, 2019
Record last verified: 2019-01