NCT06433050 Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
| NCT ID | NCT06433050 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Pennsylvania |
| Condition | Hypertrophic Cardiomyopathy Without Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 26 participants in total. It began in 2024-12-17 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are: 1. Will sotagliflozin be well tolerated in patients with nonobstructive HCM? 2. Will sotaglifozin improve exercise capacity, diastolic dysfunction and/or physical functioning in patients with nonobstructive HCM? 3. Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM? Researchers will compare sotagliflozin to a placebo (a look-alike substance that contains no drug) to see if sotagliflozin is effective at treating hypertrophic cardiomyopathy (HCM). Participants will: Take sotagliflozin or a placebo every day for 12 weeks. They will then cross-over (or switch) to taking placebo or sotagliflozin (whichever one they did not take initially) for an additional 12 weeks. Visit the clinic once every 4-12 weeks for checkups, surveys, and tests including a stress test and echocardiogram.
Eligibility Criteria
Inclusion Criteria: 1. Age at least 18 years, both sexes 2. Provision of signed and dated informed consent form 3. Stated willingness to comply with all study procedures and availability for the duration of the study 4. Ability to take oral medication and be willing to adhere to the study intervention. 5. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of administration of study drug. 6. Diagnosis of HCM with NYHA Class II-III functional class or New York Heart Association (NYHA) Class I with peak VO2 \< 90% on cardiopulmonary exercise stress testing performed at Visit 1. 7. Left ventricular outflow tract gradient \< 50 mmHg at rest, with valsalva, and with exercise. 7\. Left ventricular ejection fraction \> 50% by echocardiogram or cardiac MRI based on the most recent assessment in the past year prior to screening and confirmed during Visit 1 echocardiogram. 8\. Stable medical therapy for at least 1 month prior to study enrollment. Exclusion Criteria: 1. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor 2. Type 1 diabetes mellitus 3. Age \<18 years old 4. Pregnant or lactating women: Women of childbearing potential will undergo a urine pregnancy test during the screening visit. 5. Uncontrolled atrial fibrillation, as defined by a resting heart rate \> 100 beats per minute at the time of the baseline assessment 6. Paroxysmal atrial fibrillation (Afib) or flutter with plans to attempt to restore sinus rhythm (with drug therapy, ablation, or DC cardioversion) during the study period. 7. Unable to attain a respiratory exchange ratio of at least 1.05 on cardiopulmonary exercise test (CPET) on the day of screening. 8. Septal reduction therapy within the previous 3 months. 9. Implantable cardio-defibrillator (ICD) implantation planned during the study period. 10. Implantation of a cardiac resynchronization therapy (CRT) device within 12 weeks prior to enrollment or intent to implant a CRT device during the study period 11. Hemoglobin \< 10 g/dL 12. Estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73m\^2, or unstable or rapidly progressing renal disease at the time of randomization 13. Subject inability/unwillingness to exercise 14. Greater than moderate left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), moderate or greater mitral stenosis, or severe right-sided valvular disease based on baseline echo at the time of enrollment 15. Current angina due to clinically significant epicardial coronary disease, as per investigator judgment 16. Acute coronary syndrome or coronary intervention within the past 2 months 17. Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension) 18. Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease meeting Stage III or greater GOLD criteria (FEV1\<50% predicted), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, or current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea. 19. Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test) 20. Symptomatic bradycardia or second- or third-degree heart block, in the absence of a pacemaker 21. Significant liver disease impacting synthetic function or volume control (ALT/AST \> 3x ULN, Albumin \< 3.0 g/dL) 22. Severe right ventricular dysfunction on baseline echocardiogram 23. Orthostatic blood pressure response to the transition from supine to standing (\>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing) 24. Active participation in another study that utilizes an investigational agent (observational studies/registries allowed) 25. Any condition that, in the opinion of the investigator, will interfere with the completion of the study. This may include comorbid or psychiatric conditions that may impede successful completion of the protocol, or logistical concerns (e.g. inability to travel to the exercise unit).
Contact & Investigator
Sharlene Day, MD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06433050 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertrophic Cardiomyopathy Without Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06433050 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06433050 currently recruiting?
Yes, NCT06433050 is actively recruiting participants. Contact the research team at sharlene.day@pennmedicine.upenn.edu for enrollment information.
Where is the NCT06433050 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06433050 clinical trial?
NCT06433050 is sponsored by University of Pennsylvania. The principal investigator is Sharlene Day, MD at University of Pennsylvania. The trial plans to enroll 26 participants.