Clinical trial NCT05960890: Cohort Study of Chronic Heart Failure
Official title: Cohort Study of Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Jiangsu Taizhou People's Hospital
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: incidence of composite event (cardiovascular mortality, unplanned HF hospitalization, emergency HF intervention)
timeFrame: 2 years
Secondary outcomes:
measure: all-cause mortality
timeFrame: 2 years
Other outcomes:
measure: stroke events
timeFrame: 2 years
Locations:
city: Taizhou
country: China
facility: Taizhou People's Hospital affiliated to Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Jiangsu Taizhou People's Hospital
name: Ming Chu, Doctor
role: PRINCIPAL_INVESTIGATOR
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