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In non-ischemic dilated cardiomyopathy (NIDCM), left ventricular reverse remodeling (LVRR) can be achieved through guideline-directed medical therapy (GDMT). LVRR is defined as an increase in left ventricular ejection fraction (LVEF) of more than 10% in heart failure patients with a baseline LVEF of 40% or less, or an increase in LVEF of more than 40% at follow-up, which is classified as heart failure with improved EF (HFimpEF) according to current guidelines. Several studies have examined the prevalence and predictors of LVRR in NIDCM. However, there is a lack of research on LVRR in the context of contemporary pharmacotherapy. Studies have demonstrated the beneficial effects of ivabradine in heart failure with reduced ejection fraction (HFrEF), improving patients' prognosis. A sub-study of the SHIFT trial indicated that ivabradine may also contribute to cardiac remodeling reversal in patients with HFrEF. However, there is limited evidence exploring the relationship between ivabradine and LVRR, particularly in the context of NIDCM.
Consequently, this study is a retrospective, multi-center cohort study aiming to evaluate the impact of ivabradine on LVRR in patients with NIDCM in the current era of medical therapy. Furthermore, by conducting this study, we aim to gain insights into the potential role of ivabradine in promoting LVRR in NIDCM patients receiving contemporary drug therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| achieved HR ≥ 70 bpm without ivabradine | **Achieved HR : heart rate (HR) at 12 month follow up after the initiation of GDMT** | ||
| achieved HR < 70 bpm without ivabradine | **Achieved HR : heart rate (HR) at 12 month follow up after the initiation of GDMT** | ||
| achieved HR ≥ 70 bpm with ivabradine | **Achieved HR : heart rate (HR) at 12 month follow up after the initiation of GDMT** | ||
| achieved HR < 70 bpm with ivabradine | **Achieved HR : heart rate (HR) at 12 month follow up after the initiation of GDMT** |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of of LVRR in patients with NIDCM | LVRR is characterized by an increase in left ventricular ejection fraction (LVEF) of more than 10% in heart failure patients with a baseline LVEF of 40% or less, or an increase in LVEF of more than 40% during follow-up, which is classified as heart failure with improved EF (HFimpEF). Furthermore, the initiation of guideline-directed medical therapy (GDMT) is defined as the timeframe for commencing treatment with an angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor antagonist (ARB), or beta-blocker after the diagnosis of heart failure with reduced ejection fraction (HFrEF). | at 12 months after the initiation of GDMT |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of LVRR in NIDCM at 8 months after initiation of GDMT | at 8 months after GDMT initiation | |
| Extent of LVRR (measured by LVEDD/LVESD, LAVI, E/e' in echocardiography) in NIDCM at 8 and 12 months after GDMT initiation | at 8 and 12 months after GDMT initiation |
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Inclusion Criteria:
Diagnosed with non-ischemic dilated cardiomyopathy (NIDCM) by performing coronary artery imaging (coronary angiography, CT angiography, or SPECT scan) at the time of diagnosis of HFrEF
Sinus rhythm
Baseline LVEF of 40% or less (LVEF≤40%)
Patients containing baseline heart rate (HR)
Exclusion Criteria:
7) Contraindication to the administration of ivabradine according to the Summary of Product Characteristics (SmPC)
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Patients diagnosed with NIDCM with sinus rhythm
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| Name | Affiliation | Role |
|---|---|---|
| Seok-Min Kang | Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance hospital | Seoul | South Korea |
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| Clinical course of LVRR in NIDCM | at 8 and 12 months after GDMT initiation |
| Effect of targeted HR (HF <60 or 70/min) on LVRR in NIDCM at 8 and 12 months after GDMT initiation | at 8 and 12 months after GDMT initiation |
| Effect of degree of change in HR before and after GDMT on LVRR in NIDCM at 8 and 12 months after GDMT initiation | at 8 and 12 months after GDMT initiation |
| Impact of GDMT on LVRR in NIDCM at 8 and 12 months after GDMT initiation | at 8 and 12 months after GDMT initiation |
| Prevalence of symptomatic bradycardia, syncope, or any other adverse events with Ivabradine | at 8 and 12 months after GDMT initiation |
| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D020257 | Ventricular Remodeling |
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
| D000083083 | Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006333 | Heart Failure |
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