Prognostic and Diagnostic Value of Biomarkers and Cardiac Functional Parameters in Patients With Chronic Heart Failure

Recruiting

• Conditions: Chronic Heart Failure
• Interventions: Other: Observational study

• Registration Number: NCT02776384
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

The study aims to investigate whether disease progression in patients with chronic heart failure (CHF) can be assessed by new biomarkers, and determine their diagnostic value. The study also intends to describe comparison of echocardiography with cardiopulmonary function test in CHF patients, and relating these cardiac functional parameters to clinical outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-05
• Study First Submitted: 2016-05-15
• Study First Submitted QC: 2016-05-15
• Last Update Submitted: 2016-05-15
• Study First Posted: 2016-05-18
• Last Update Posted: 2016-05-18
• Primary Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Age ≥18 years
• with symptoms and signs in NYHA Ⅱ~Ⅳ
• with cardiac structural changes confirmed by echocardiography

Exclusion Criteria

• with other severe diseases combined and will be alive for less than 12 months
• hard to participate in the investigation or accept the follow-up visits
• pregnant or lactating women
• during the acute phase of ST-elevation acute myocardial infarction, stroke, severe infection and other critical conditions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic heart failure	Observational study	patients who are diagnosed with chronic heart failure with either preserved or reduced ejection fraction

Primary Outcome Measures

Name	Time	Method
cardiovascular mortality	10 years
main adverse cardiovascular and cerebrovascular events, MACCE	10 years	MACCE includes all-cause mortality, cardiovascular mortality, nonfatal myocardial infarction, nonfatal stroke, target lesion revascularization and HF rehospitalization

Secondary Outcome Measures

Name	Time	Method
new stroke	10 years
all-cause mortality	10 years
heart failure rehospitalization	10 years
quality of life	10 years	described in quality of life scores
worsening of renal function	10 years	either an increase of 0.3 mg/dl in serum creatinine or a 20% decrease in eGFR compared with baseline
new myocardial infarction	10 years

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China