A Clinical Follow-up Study of Heart Failure Patients.

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital
    • Contact: Zhangwei Chen; Phone Number: +8602164041990; Email: chen.zhangwei@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The inpatient in the department of cardiology of Zhongshan Hospital, Fudan University will be selected.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
NC; Patients without heart failure.
DCM; Dilated cardiomyopathy patients.
ICM; Ischemic cardiomyopathy patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospitalization for cardiac causes	hospitalization for cardiac causes during follow-up	one year after enrolled
left ventricular end-diastolic dimension(LVEDD) dilates.	left ventricular structure changes:left ventricular end-diastolic dimension(LVEDD) dilates.	one year after enrolled
left ventricular ejection fraction reduces	left ventricular function changes:left ventricular ejection fraction reduces	one year after enrolled

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 9, 2019

Study Record Updates

• Last Update Posted (Actual): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HF201801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No