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Exploration of Clonal Hematopoiesis of Indeterminate Potential in Non-ischemic Heart Failure With Reduced Ejection Fraction

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT05981144
Collaborator
(none)
100
Enrollment
1
Location
14.3
Actual Duration (Months)
7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clonal hematopoiesis of indeterminate potential (CHIP) refers to a phenomenon in which blood cells with somatic mutation circulate in the peripheral blood due to abnormal proliferation and differentiation of mutant hematopoietic cells.

CHIP is considered one of the aging phenomena, and the mutant blood cells increased by CHIP cause chronic inflammation, thereby increasing the occurrence of atherosclerotic cardiovascular disease. Therefore, CHIP is known to be closely related to poor prognosis of ischemic heart failure. Meanwhile, chronic inflammation may be involved in the development of non-ischemic myocardial disease, which is one of the major causes of heart failure.

This study will identify CHIP and perform NLRP3 inflammasome assay in 100 non-ischemic heart failure patients and evaluate the relationship between CHIP and inflammation, imaging markers of heart failure, Left ventricle reverse remodeling after guideline-directed medical treatment, and prognosis of heart failure with reduced ejection fraction.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Exploration of Clonal Hematopoiesis of Indeterminate Potential in Non-ischemic Heart Failure With Reduced Ejection Fraction
    Actual Study Start Date :
    Nov 23, 2021
    Actual Primary Completion Date :
    Jan 31, 2023
    Actual Study Completion Date :
    Jan 31, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Experimental

    Patients with heart failure without significant stenosis of the major epicardial coronary artery and reduced left ventricular ejection fraction below 40%

    Outcome Measures

    Primary Outcome Measures

    1. Left ventricular reverse remodeling [3 months after guideline-directed medical treatment]

      a second measurement of left ventricular ejection fraction > 40% and a ≥10% increase from baseline left ventricular ejection fraction of ≤ 40%

    Secondary Outcome Measures

    1. Clinical outcome [3 years after enrollment]

      Heart failure hospitalization or cardiovascular death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. As an adult over the age of 19

    2. A history of left ventricular ejection fraction less than 40% on imaging tests within 3 years (HFrEF diagnosis),

    3. Have a cardiac MRI taken within 3 months of being diagnosed with HFrEF,

    4. A person who was diagnosed with non-ischemic left ventricular hypofunction heart failure by performing coronary artery imaging (angiography, CT) at the time of diagnosis of HFrEF

    Exclusion Criteria:

    1. Patients with confirmed ischemic cardiomyopathy (when stenosis of 75% or more of major coronary arteries is confirmed on coronary artery imaging or ischemic cardiomyopathy findings such as transmural late gadolinium enhancement on cardiac MRI)

    2. History of solid cancer diagnosis and chemotherapy (drugs, radiation)

    3. History of blood cancer

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Chan Joo Lee, Division of Cardiology, Severance Hospital, Yonsei University College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05981144
    Other Study ID Numbers:
    • 4-2021-0921
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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 Aug 8, 2023