Status:
UNKNOWN
The Impact of Ivabradine on Left Ventricular Reverse Remodeling in Nonischemic Dilated Cardiomyopathy (NIDCM) on Current Medical Therapy Era
Lead Sponsor:
Yonsei University
Conditions:
Dilated Cardiomyopathy
Ventricular Remodeling
Eligibility:
All Genders
19-90 years
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 ven...
Eligibility Criteria
Inclusion
- 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)
- In the Ivabradine group, baseline HR must be \>75 bpm at the time of ivabradine dosing.
Exclusion
- 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)
- Heart failure with other etiologies (e.g., valvular heart disease, endocrine disease).
- Previous recovery history of left ventricular systolic function (LVEF)
- Cardiac resynchronization therapy (CRT) implantation
- 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).
Key Trial Info
Start Date :
July 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05973591
Start Date
July 15 2023
End Date
December 31 2024
Last Update
August 3 2023
Active Locations (1)
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1
Severance hospital
Seoul, South Korea