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.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Reduced Ejection Fraction

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who need ACEI for cardiovascular disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular reverse remodeling	a second measurement of left ventricular ejection fraction > 40% and a ≥10% increase from baseline left ventricular ejection fraction of ≤ 40%	3 months after guideline-directed medical treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome	Heart failure hospitalization or cardiovascular death	3 years after enrollment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 4-2021-0921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No