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

NCT05981144 | Completed

• 1 other identifier: 4-2021-0921
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical outcome

  3 years after enrollment

Study Arms (1)

Experimental

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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who need ACEI for cardiovascular disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance hospital

Seoul, South Korea

Location

Study Officials

• Chan Joo Lee

  Division of Cardiology, Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: November 23, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

KR (1)