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

Completed

• Conditions: Heart Failure With Reduced Ejection Fraction

• Registration Number: NCT05981144
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-23
• Primary Completion: 2023-01-31
• Study Completion: 2023-01-31
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical outcome	3 years after enrollment	Heart failure hospitalization or cardiovascular death

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of