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Completed

NCT Number: NCT05981144

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

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.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • As an adult over the age of 19
  • A history of left ventricular ejection fraction less than 40% on imaging tests within 3 years (HFrEF diagnosis),
  • Have a cardiac MRI taken within 3 months of being diagnosed with HFrEF,
  • A person who was diagnosed with non-ischemic heart failure by performing coronary artery imaging (angiography, CT) at the time of diagnosis of HFrEF

Exclusion criteria

  • 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)
  • History of solid cancer diagnosis and chemotherapy (drugs, radiation)
  • History of blood cancer

Treatment and study plan

Primary outcomes

  1. Left ventricular reverse remodeling

    Time frame: 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 outcomes

  1. Clinical outcome

    Time frame: 3 years after enrollment

    Heart failure hospitalization or cardiovascular death

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Nov 13, 2023

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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