Cohort Study of Chronic Heart Failure

ConditionHeart Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorJiangsu Taizhou People's Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Remote monitoring assisted by community physicians
Behavioral
Patients upload data such as wristband data, blood pressure, weight through their mobile phones, while physicians can check the data on the platform. Upon detecting alerts, community physicians review participant-related medical information, conduct structured symptom assessments via "StarNet Home" platform/phone within 2 hours, and initiate protocol-guided interventions (e.g., diuretic adjustment for fluid overload).

Treatment groups

1,000 Participants

are divided into 2 treatment groups

Group A: Routine management groupNo intervention 0 interventions

Group B: Remote home management group assisted by community physiciansExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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

Time frame

2 years

Secondary outcomes

all-cause mortality

Time frame

2 years

Other outcomes

stroke events

Time frame

2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Taizhou People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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