Dilated CardiomyopathyNCT05973591
The Impact of Ivabradine on Left Ventricular Reverse Remodeling in Nonischemic Dilated Cardiomyopathy (NIDCM) on Current Medical Therapy Era
An observational study of Dilated Cardiomyopathy and Ventricular Remodeling, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Dilated Cardiomyopathy, Ventricular Remodeling, Heart Failure, Reduced Ejection Fraction
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jul 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with NIDCM with sinus rhythm
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Medical subject headings
- Cardiomyopathy, Dilated, Ventricular Remodeling, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 12 months after the initiation of GDMT
Secondary outcomes (7)
Prevalence of LVRR in NIDCM at 8 months after initiation of GDMT
Measured: 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
Measured: at 8 and 12 months after GDMT initiation
Clinical course of LVRR in NIDCM
Measured: 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
Measured: 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
Measured: at 8 and 12 months after GDMT initiation
Impact of GDMT on LVRR in NIDCM at 8 and 12 months after GDMT initiation
Measured: at 8 and 12 months after GDMT initiation
Prevalence of symptomatic bradycardia, syncope, or any other adverse events with Ivabradine
Measured: at 8 and 12 months after GDMT initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start15 Jul 2023
- Primary completionJun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seok-Min Kang, Principal investigator, Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973591
- Sponsor's protocol ID
- 4-2022-1665
- Status last verified
- Jul 2023
- First submitted
- 16 Jul 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ivabradine on Left Ventricular Reverse Remodeling in Nonischemic Dilated Cardiomyopathy (NIDCM) on Current Medical Therapy Era
- ClinicalTrials.gov ID
- NCT05973591
- Acronym / sponsor ID
- 4-2022-1665
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with NIDCM with sinus rhythm
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of of LVRR in patients with NIDCM
Time frame: at 12 months after the initiation of GDMT
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).
7 secondary outcomes
Prevalence of LVRR in NIDCM at 8 months after initiation of GDMT
Time frame: 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
Time frame: at 8 and 12 months after GDMT initiation
Clinical course of LVRR in NIDCM
Time frame: 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
Time frame: 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
Time frame: at 8 and 12 months after GDMT initiation
Impact of GDMT on LVRR in NIDCM at 8 and 12 months after GDMT initiation
Time frame: at 8 and 12 months after GDMT initiation
Prevalence of symptomatic bradycardia, syncope, or any other adverse events with Ivabradine
Time frame: at 8 and 12 months after GDMT initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok-Min Kang principal investigator
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dilated Cardiomyopathy and Ventricular Remodeling, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of of LVRR in patients with NIDCM (time frame: at 12 months after the initiation of GDMT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.