Cohort Study of Chronic Heart Failure

Not Applicable

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT05960890
• Lead Sponsor: Jiangsu Taizhou People's Hospital

Brief Summary

The goal of this observational study is to learn about the influencing factors of chronic heart failure prognosis in heart failure patients. The main question it aims to answer is that what are the influencing factors of clinical outcomes in chronic heart failure. Participants will be collected multiple omics data such as phenotype group, environmental exposure group, intestinal microbiome, genome, metabolome, and noninvasive biomarkers.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-08
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-23
• Study First Posted: 2023-07-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-29
• Last Update Posted: 2025-05-31
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

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

Inclusion Criteria

1. Age ≥18 years;
2. Fulfill at least one of the following criteria：①History of chronic heart failure;②New-onset heart failure with LVEF <50%；③New-onset heart failure with LVEF≧50%，E/e'≧15 and BNP>400 pg/mL/NT-proBNP(<50 years, >450 pg/mL; 50~75 years, >900 pg/mL; >75 years, >1800 pg/mL)
3. Etiology: dilated cardiomyopathy, hypertensive heart disease, ischaemic cardiomyopathy, Non-severe valvular heart disease；
4. Primary post-discharge therapy: oral medication;
5. Sign the informed consent form.

Exclusion Criteria

1. Patients with renal failure (Ccr<30ml/min) or patients on dialysis therapy;
2. Various correctable secondary causes of cardiac insufficiency including hyperthyroid heart disease, anaemic heart disease, uncorrected congenital heart disease; severe valvular heart disease (including severe stenosis or closure of organic aortic and mitral valves);
3. Patients with indications for pacemaker implantation but have not received a pacemaker implant;
4. Patients with chronic obstructive pulmonary disease accompanied by type II respiratory failure.
5. Patients who cannot understand and sign an informed consent form.
6. Patients with mental illness, pregnant women, and other special populations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
incidence of composite event (cardiovascular mortality, unplanned HF hospitalization, emergency HF intervention)	2 years	Cardiovascular disease death, heart failure readmission and emergency HF intervention are three endpoint events, with either occurring as the primary endpoint

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	2 years	all-cause mortality

Trial Locations

Locations (1)

Taizhou People's Hospital affiliated to Nanjing Medical University; 🇨🇳 Taizhou, Jiangsu, China