Relationship Between Coronary Microvascular Dysfunction and Improvement of Left Ventricular Systolic Function in Patients With Heart Failure With Reduced Ejection Fraction Caused by Non-ischemic Etiology

NCT06243653 | Recruiting

• 1 other identifier: HFrEF-CMD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the incidence of coronary microvascular dysfunction (CMD) and its prognostic implication for the improvement of left ventricular function in patients who have been diagnosed with heart failure with reduced ejection fraction (HFrEF) caused by non-ischemic etiology.

Conditions

Heart Failure; Microvascular Angina; Non-ischemic Cardiomyopathy

Keywords

coronary microvascular dysfunction; non-ischemic cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Proportion of HFiEF* at 12 months

  HFiEF was defined as LVEF \>40% measured by echocardiography at 12 months.1

  1-year follow-up

Secondary Outcomes (20)

• Correlation between CMD and left ventricular end diastolic pressure

  1 year

• Correlation between CMD and delta LVEF from baseline to 12 months

  1 year

• Correlation between CMD and E/e'

  1 year

• Correlation between CMD and delta LV systolic dimension from baseline to 12 months

  1 year

• Correlation between CMD and delta LV diastolic dimension from baseline to 12 months

  1-year follow-up

Study Arms (1)

HFrEF

Patients with heart failure with reduced ejection fraction (HFrEF) without significant coronary artery disease (non-ischemic cardiomyopathy)

Diagnostic Test: CMD test

Interventions

CMD test DIAGNOSTIC_TEST

Measured CFR and IMR

Also known as: Coronary microvascular dysfunction

HFrEF

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with heart failure with reduced ejection fraction (HFrEF) without significant coronary artery disease (non-ischemic cardiomyopathy)

You may qualify if:

• a) Subject must be at least 19 years of age. b) Subject with symptoms or signs of HF (NYHA ≥2 dyspnea) and reduced ejection fraction (LVEF ≤ 40%) c) Subject who clinically need coronary angiography d) Subject who can voluntarily sign informed consent form

You may not qualify if:

• a) Subject with significant coronary artery stenosis on coronary angiography (diameter stenosis ≥90% or 50-90% with fractional flow reserve \[FFR\] ≤0.80) b) Subject scheduled for cardiac replacement therapy (heart transplantation or left ventricular assisted device \[LVAD\] implantation) c) HF due to restrictive cardiomyopathy, active myocarditis, or constrictive pericarditis d) Significant valvular heart disease requiring surgery e) Subject who have non-cardiac co-morbid conditions with life expectancy \<1 year

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure; Microvascular Angina

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Angina Pectoris; Myocardial Ischemia; Vascular Diseases

Study Officials

• Ki Hong Choi, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ki Hong Choi, MD

CONTACT

82-2-3410-3419; cardiokh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 6, 2024
• Study Start: August 9, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

KR (1)