A Clinical Follow-up Study of Heart Failure Patients.

Heart Failure Clinical Trial

Official title:

A Clinical Follow-up Study of Heart Failure Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03797742
• Other study ID #: HF201801
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2019
• Source: Shanghai Zhongshan Hospital
• Contact: Zhangwei Chen
• Phone: +86 021 64041990
• Email: chen.zhangwei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NYHA functional class	NYHA cardiac functional class	one year after enrolled
Primary	All-cause mortality	All-cause mortality during follow-up	one year after enrolled
Secondary	hospitalization for cardiac causes	hospitalization for cardiac causes during follow-up	one year after enrolled
Secondary	left ventricular end-diastolic dimension(LVEDD) dilates.	left ventricular structure changes:left ventricular end-diastolic dimension(LVEDD) dilates.	one year after enrolled
Secondary	left ventricular ejection fraction reduces	left ventricular function changes:left ventricular ejection fraction reduces	one year after enrolled