UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054949 |
|---|---|
| Receipt number | R000062771 |
| Scientific Title | Randomized controlled trial to evaluate the effect of SGLT2 inhibitors on exercise tolerance in non-obstructive hypertrophic cardiomyopathy |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2025/01/11 12:37:46 |
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Basic information
Public title
Randomized controlled trial to evaluate the effect of SGLT2 inhibitors on exercise tolerance in non-obstructive hypertrophic cardiomyopathy
Acronym
S-HNCM-HF trial
Scientific Title
Randomized controlled trial to evaluate the effect of SGLT2 inhibitors on exercise tolerance in non-obstructive hypertrophic cardiomyopathy
Scientific Title:Acronym
S-HNCM-HF trial
Region
| Japan |
Condition
Condition
Hypertrophic Cardiomyopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To compare the changes in exercise tolerance before and after taking SGLT2 inhibitors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximal oxygen uptake peak VO2 by cardiopulmonary exercise test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A (SGLT2 inhibitor pre-treatment group)
Interventions/Control_2
Group B (SGLT2 inhibitor post group)
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. Patients with symptomatic non-obstructive hypertrophic cardiomyopathy (left ventricular wall thickness of at least 15 mm, or 13 mm if there is a family history, and left ventricular outflow tract pressure gradient of less than 30 mmHg at rest and during provocation)
2. NYHA (New York Heart Association functional classification) classification II or III heart failure symptoms
3. Preserved left ventricular ejection fraction on transthoracic echocardiography or cardiac MRI
4. taking beta-blockers
5. The patient is at least 20 years of age at screening.
Key exclusion criteria
1. Patients with systolic blood pressure less than 100 mmHg
2. eGFR less than 30 ml/min/1.73 m2 (including dialysis patients)
3. Patients who are taking SGLT2 inhibitors at the time of screening (however, patients will not be excluded if they discontinue the medication and have a 4-week washout period)
4. Patients with pulmonary disease that limits exercise capacity or systemic arterial oxygen saturation
5. Patients with a condition that precludes an exercise tolerance test
6. Patients with persistent or permanent atrial fibrillation
7. Patients with paroxysmal atrial fibrillation and atrial fibrillation at screening
8. Patients with serious liver disease
9. Patients with a history of myocardial infarction (elevated myocardial enzymes with ischemic symptoms or new ischemic ECG changes), coronary artery bypass surgery, or other major cardiovascular surgery, stroke or transient ischemic attack in the past 90 days
10. Patients with a history of exercise-induced syncope or sustained ventricular tachyarrhythmia within 6 months prior to screening
11. Patients with a history of resuscitation from sudden cardiac arrest (at any time of the day) or a life-threatening ventricular arrhythmia for which an implantable cardioverter-defibrillator ICD was appropriately activated within 6 months prior to screening
12. Patients with urinary tract infection or other infectious diseases at screening
13. Patients with moderate or severe aortic valve stenosis at screening
14. Patients with contraindications to the investigational drug, such as being pregnant, possibly pregnant, or diagnosed with a severe allergy to the investigational drug
15. Other patients who are deemed inappropriate to participate in this study by the Principal Investigator or a Research Associate.
16. Patients who require a surrogate, who are unable to give written consent, or who are unable to understand the outline or purpose of the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Maekawa |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine III
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu
TEL
0534352265
ymaekawa@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Maekawa |
Organization
Hamamatsu University School of Medicine
Division name
Internal Medicine III
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu
TEL
0534352265
Homepage URL
ymaekawa@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Company
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Board of Hamamatsu University School of Medicine
Address
1-20-1 handayama, Chuo-ku, Hamamatsu, Shizuoka
Tel
053-435-2680
kenkyou.s@hama-med.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
| 2024 | Year | 09 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062771
