The Impact of Ivabradine on Left Ventricular Reverse Remodeling in Nonischemic Dilated Cardiomyopathy (NIDCM) on Current Medical Therapy Era

NCT ID: NCT05973591

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-15
• Study Completion Date: 2024-12-31

Brief Summary

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.

Conditions

Dilated Cardiomyopathy; Ventricular Remodeling; Heart Failure, Reduced Ejection Fraction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

achieved HR ≥ 70 bpm without ivabradine

\*\*Achieved HR : heart rate (HR) at 12 month follow up after the initiation of GDMT\*\*

No interventions assigned to this group

achieved HR < 70 bpm without ivabradine

\*\*Achieved HR : heart rate (HR) at 12 month follow up after the initiation of GDMT\*\*

No interventions assigned to this group

achieved HR ≥ 70 bpm with ivabradine

\*\*Achieved HR : heart rate (HR) at 12 month follow up after the initiation of GDMT\*\*

No interventions assigned to this group

achieved HR < 70 bpm with ivabradine

\*\*Achieved HR : heart rate (HR) at 12 month follow up after the initiation of GDMT\*\*

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. 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

2. Sinus rhythm

3. Baseline LVEF of 40% or less (LVEF≤40%)

4. Patients containing baseline heart rate (HR)

• In the Ivabradine group, baseline HR must be >75 bpm at the time of ivabradine dosing.

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 LGE on cardiac MRI)

2. Heart failure with other etiologies (e.g., valvular heart disease, endocrine disease).

3. Previous recovery history of left ventricular systolic function (LVEF)

4. Cardiac resynchronization therapy (CRT) implantation

5. Persistent/permanent atrial fibrillation

7) Contraindication to the administration of ivabradine according to the Summary of Product Characteristics (SmPC)

• Hypersensitivity reactions
• Symptomatic bradycardia or resting heart rate < 75 bpm prior to treatment
• Cardiogenic shock, acute myocardial infarction, severe hypotension (< 90/50 mmHg), severe hepatic failure, sinus syndrome, atrial block, unstable or acute heart failure, pacemaker dependence (with pacing dominance), unstable angina, third degree atrioventricular block
• Cytochrome P450 3A4 inhibitors: Azole class antifungals (ketoconazole,itraconazole), Macrolide class antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir), nefazodone or any concomitant use with verapamil or diltiazem (moderate CYP3A4 inhibitors with heart rate reducing properties).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seok-Min Kang

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Severance hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2022-1665

Identifier Type: -

Identifier Source: org_study_id