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Clinical Trials/NCT05960890
NCT05960890
Recruiting
Not Applicable

Cohort Study of Chronic Heart Failure

Jiangsu Taizhou People's Hospital1 site in 1 country1,000 target enrollmentJune 8, 2023
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Jiangsu Taizhou People's Hospital
Enrollment
1000
Locations
1
Primary Endpoint
incidence of composite event (cardiovascular mortality, unplanned HF hospitalization, emergency HF intervention)
Status
Recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 8, 2023
End Date
December 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jiangsu Taizhou People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ming Chu

The deputy dean of the hospital

Jiangsu Taizhou People's Hospital

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years;
  • 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)
  • Etiology: dilated cardiomyopathy, hypertensive heart disease, ischaemic cardiomyopathy, Non-severe valvular heart disease;
  • Primary post-discharge therapy: oral medication;
  • Sign the informed consent form.

Exclusion Criteria

  • Patients with renal failure (Ccr\<30ml/min) or patients on dialysis therapy;
  • 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);
  • Patients with indications for pacemaker implantation but have not received a pacemaker implant;
  • Patients with chronic obstructive pulmonary disease accompanied by type II respiratory failure.
  • Patients who cannot understand and sign an informed consent form.
  • Patients with mental illness, pregnant women, and other special populations.

Outcomes

Primary Outcomes

incidence of composite event (cardiovascular mortality, unplanned HF hospitalization, emergency HF intervention)

Time Frame: 2 years

Cardiovascular disease death, heart failure readmission and emergency HF intervention are three endpoint events, with either occurring as the primary endpoint

Secondary Outcomes

  • all-cause mortality(2 years)

Study Sites (1)

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