Cohort Study of Chronic Heart Failure (CHF)

Jiangsu Taizhou People's Hospital

Status: Enrolling

Conditions: Heart Failure

Treatments: Behavioral: Remote monitoring assisted by community physicians

Study type: Interventional

Funder types: Other

Identifiers

NCT05960890

IIT202305

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Routine management group

No Intervention group

Remote home management group assisted by community physicians

Experimental group

Treatment:

Behavioral: Remote monitoring assisted by community physicians