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NCT Number: NCT05960890

Cohort Study of Chronic Heart Failure

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taizhou People's Hospital affiliated to Nanjing Medical University

Taizhou, Jiangsu, 225300, China

Location status: Recruiting

Location contact

Yucheng Wu, Doctor

CONTACT

[email protected]

+8618360010750

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. all-cause mortality

    Time frame: 2 years

    all-cause mortality

Other outcomes

  1. stroke events

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Lichun Wang, Master

CONTACT

[email protected]

+8613775704547

Yucheng Wu, Doctor

CONTACT

[email protected]

+8618360010750

Sponsors and collaborators

Lead sponsor

Jiangsu Taizhou People's Hospital

Other

Registry information

Acronym: CHF

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Jul 27, 2023
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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