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CHF: Cohort Study of Chronic Heart Failure

Sponsor
Jiangsu Taizhou People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05960890
Collaborator
(none)
1,000
Enrollment
1
Location
41.8
Anticipated Duration (Months)
23.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cohort Study of Chronic Heart Failure
    Actual Study Start Date :
    Jun 8, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Composite endpoint of cardiovascular death and rehospitalization for heart failure [2 years]

      Cardiovascular disease death and heart failure readmission are two endpoint events, with either occurring as the primary endpoint

    Secondary Outcome Measures

    1. all-cause mortality [2 years]

      all-cause mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Over 18 years old

    2. Dilated cardiomyopathy, hypertensive cardiomyopathy, ischemic cardiomyopathy (coronary heart disease), non-severe valvular heart disease

    3. LVEF<50%, and/or NT-proBNP>1800ng/L, and/or BNP>100ng/L, NYHA I-III grade

    4. Able to understand and sign informed consent forms

    Exclusion Criteria:

    1. Expected life less than 3 months

    2. Patients with severe renal insufficiency (Ccr<30ml/min) or undergoing dialysis treatment

    3. Cardiac insufficiency caused by various secondary causes that can be corrected includes hyperthyroid heart disease, anemic heart disease, and uncorrected Congenital heart defect

    4. Presence of indications for pacemaker implantation and absence of pacemaker implantation

    5. Chronic obstructive pulmonary disease with type II Respiratory failure

    6. Special populations such as mental illness patients and pregnant women

    7. Unable to understand and sign informed consent form

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taizhou People's Hospital affiliated to Nanjing Medical University Taizhou Jiangsu China 225300

    Sponsors and Collaborators

    • Jiangsu Taizhou People's Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ming Chu, The deputy dean of the hospital, Jiangsu Taizhou People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05960890
    Other Study ID Numbers:
    • IIT202305
    First Posted:
    Jul 27, 2023
    Last Update Posted:
    Jul 27, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Jul 27, 2023