Comparing ARNI and ACE Inhibitor/ARB medications for heart failure
The Comparative Effectiveness Study Between ARNI and ACE Inhibitor/ARB Medication in Patient With Heart Failure With Reduced Ejection Fraction Using the Nationwide Population Based Real World Registry of Korean Heart Failure
This study is testing whether a new heart medication called ARNI works better and is safer than traditional medications for people with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wonju Severance Christian Hospital Academic / other |
| Locations | 1 site (Wonju, Gangwondo) |
| Trial ID | NCT05329727 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness, safety, and cost-effectiveness of Angiotensin Receptor Neprilysin Inhibitors (ARNI) compared to ACE inhibitors and ARBs in patients with heart failure with reduced ejection fraction (HFrEF). It aims to identify unmet medical needs in real-world practice and inform healthcare policy and clinical guidelines for heart failure treatment in Korea. The study utilizes data from the Korean National Health Insurance Claims database to assess treatment patterns and outcomes among heart failure patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with heart failure with reduced ejection fraction, particularly those who have been hospitalized for their condition.
Not a fit: Patients under 18 years old or those for whom participation is deemed inappropriate by investigators will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and guidelines for managing heart failure, ultimately reducing mortality and hospital readmissions.
How similar studies have performed: Other studies have shown promising results with similar approaches, particularly in evaluating the effectiveness of ARNI in heart failure management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HF patients were defined as those with "heart failure" according to the disease code in the main code and the sub-code in the claims data. HF patients who were assigned the following KCD-6 disease codes were considered as: "hypertensive heart disease with (congestive) HF" (I11.0), "hypertensive heart and renal disease with (congestive) HF" (I13.0), "hypertensive heart and renal disease with both (congestive) HF and renal failure" (I13.2), and "HF" (I50) including "congestive HF" (I50.0), "LV failure" (I50.1), and "HF and unspecified" (I50.9). * HFrEF patients were defined with the following KCD-6 disease codes: "Congestive heart failure with systolic dysfunction"(I5004), "Left ventricular failure"(I501), "Ischaemic cardiomyopathy"(I22.5), "Dilated cardiomyopathy" (I420). Hospitalized heart failure is defined as the HF disease code and admission. Exclusion Criteria: * Less than 18 years old * In case where investigators determine it's inappropriate to be included in the study as per investigators' clinical judgment
Where this trial is running
Wonju, Gangwondo
- Yonsei University Wonju College of Medicine — Wonju, Gangwondo, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Byung Su Yoo, MD,PhD — Yonsei Wonju Christian Hospital
- Study coordinator: Dong-Hyuk Cho, MD,PhD
- Email: why012@gmail.com
- Phone: 82-33-741-0916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.