Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
United States26 participantsStarted 2024-12-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age at least 18 years, both sexes
✓. Provision of signed and dated informed consent form
✓. Stated willingness to comply with all study procedures and availability for the duration of the study
✓. Ability to take oral medication and be willing to adhere to the study intervention.
✓. 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.
✓. 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.
✓. Left ventricular outflow tract gradient \< 50 mmHg at rest, with valsalva, and with exercise.
Exclusion criteria
✕. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor
What they're measuring
1
Number of participants with treatment-related adverse events
✕. Pregnant or lactating women: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.
✕. Uncontrolled atrial fibrillation, as defined by a resting heart rate \> 100 beats per minute at the time of the baseline assessment
✕. 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.
✕. Unable to attain a respiratory exchange ratio of at least 1.05 on cardiopulmonary exercise test (CPET) on the day of screening.
✕. Septal reduction therapy within the previous 3 months.