Randomized controlled trial to evaluate the effect of SGLT2 inhibitors on exercise tolerance in non-obstructive hypertrophic cardiomyopathy

UMIN ID: UMIN000054949

Registered date:30/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Hypertrophic Cardiomyopathy
• Date of first enrollment: 2024/08/20
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A (SGLT2 inhibitor pre-treatment group)
Group B (SGLT2 inhibitor post group)

Outcome(s)

• Primary Outcome: Maximal oxygen uptake peak VO2 by cardiopulmonary exercise test

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Hamamatsu University School of Medicine
• Source(s) of Monetary Support: Company