Cohort Study of Chronic Heart Failure (CHF)

May 18, 2026 updated by: Ming Chu, Jiangsu Taizhou People's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Taizhou, Jiangsu, China, 225300
        • Recruiting
        • Taizhou People's Hospital affiliated to Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Adult population with chronic heart failure

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine management group
Experimental: Remote home management group assisted by community physicians
Behavioral: Remote monitoring assisted by community physicians
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: 2 years
all-cause mortality
2 years

Other Outcome Measures

Outcome Measure
Time Frame
stroke events
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Taizhou People's Hospital

Investigators

  • Principal Investigator: Ming Chu, Doctor, Jiangsu Taizhou People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 23, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT202305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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