UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052909 |
|---|---|
| Receipt number | R000060369 |
| Scientific Title | Investigation of the Effects of Discontinuing Beta Blockers on Exercise Tolerance in Patients with Chronic Myocardial Infarction and Preserved Left Ventricular Ejection Fraction |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2023/11/26 21:54:23 |
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Basic information
Public title
Investigation of the Effects of Discontinuing Beta Blockers on Exercise Tolerance in Patients with Chronic Myocardial Infarction and Preserved Left Ventricular Ejection Fraction
Acronym
Investigation of the Effects of Discontinuing Beta Blockers on Exercise Tolerance in Patients with Chronic Myocardial Infarction and Preserved Left Ventricular Ejection Fraction
Scientific Title
Investigation of the Effects of Discontinuing Beta Blockers on Exercise Tolerance in Patients with Chronic Myocardial Infarction and Preserved Left Ventricular Ejection Fraction
Scientific Title:Acronym
Investigation of the Effects of Discontinuing Beta Blockers on Exercise Tolerance in Patients with Chronic Myocardial Infarction and Preserved Left Ventricular Ejection Fraction
Region
| Japan |
Condition
Condition
Chronic Myocardial Infarction with Preserved Left Ventricular Ejection Fraction"
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Optimal medical therapy and percutaneous coronary intervention (PCI) are commonly practiced treatments for patients with acute myocardial infarction in Japan. During the acute phase, advancements in PCI have increasingly allowed for the early restoration of coronary blood flow, potentially preventing a reduction in left ventricular ejection fraction (LVEF). However, many studies underpinning optimal medical therapy predate the widespread adoption of PCI, leading to a disconnect with current clinical practice. Among the optimal medical therapies, indications for beta blockers have been based on research conducted before the widespread use of PCI. Therefore, in Japan's guidelines, while the administration of beta blockers is recommended for myocardial infarction patients who show signs of heart failure or have an LVEF of 40% or less, its use in other patients is only considered on a case-by-case basis. In Western guidelines, due to insufficient research on the significance and efficacy of beta blockers in patients with chronic myocardial infarction and preserved LVEF, the decision to prescribe beta blockers is to be made according to heart failure treatment guidelines. In these guidelines, the effectiveness of beta blockers in heart failure patients with preserved LVEF is not clear, and recent reports suggest that reducing or discontinuing beta blockers in heart failure patients with an LVEF over 50% can improve maximum exercise tolerance and heart rate response. In the realm of ischemic heart disease, when LVEF is preserved, the possibility that beta blocker therapy may worsen exercise tolerance and heart rate response cannot be denied. This study aims to elucidate the effects of discontinuing beta blockers on various parameters of cardiopulmonary exercise testing, including maximum exercise tolerance, in chronic myocardial infarction patients with preserved LVEF over 50% who are on beta blocker therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Parameters (PeakVO2) in Cardiopulmonary Exercise Testing After 4 Weeks
Key secondary outcomes
Changes in Coronary Artery Disease Risk (blood pressure, lipid profile, diabetes biomarkers), Changes in Blood Test Parameters, Changes in Echocardiography Parameters, and the Occurrence of Events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After confirming eligibility, cardiopulmonary exercise testing, transthoracic echocardiography, and blood tests will be conducted. Following these tests, the dose of beta blockers will be reduced to half for approximately two weeks. After that, the beta blockers will be discontinued, and approximately two weeks later, cardiopulmonary exercise testing, transthoracic echocardiography, and blood tests will be conducted again.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The age at the time of consent acquisition is 20 years or older.
2. The individual has received a sufficient explanation regarding participation in this study, understood it fully, and provided written consent of their own free will.
3. At least six months have passed since the onset of myocardial infarction.
4. Left ventricular ejection fraction is preserved at 50 % or above.
5. The individual is currently taking beta blockers
Key exclusion criteria
1. Individuals using implantable medical devices such as cardiac pacemakers or defibrillators.
2. Patients taking beta blockers for tachyarrhythmias.
3. Patients taking digitalis preparations, calcium channel blockers (verapamil, diltiazem), or ivabradine.
4. Patients diagnosed with acute phase of acute myocardial infarction, unstable angina not stable with medical treatment, uncontrolled arrhythmias causing symptoms or hemodynamic abnormalities, uncontrolled heart failure, uncontrolled hypertension, symptomatic severe aortic stenosis, or mental illness that precludes communication.
Definition of heart failure symptoms:
a) Dyspnea induced at rest or with mild exertion.
b) At least two of the following: jugular venous distention, pulmonary rales, peripheral edema, or chest Xray showing pulmonary congestion.
5. Patients deemed unsuitable for the study by the principal investigator or co-investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomotaka |
| Middle name | |
| Last name | Dohi |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
t-dohi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Nishio |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
r-nishio@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Ryota Nishio
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Graduate School of Medicine
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
kenkyu5858@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 26 | Day |
Last modified on
| 2023 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060369
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| Registered date | File name |
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