About this trial
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
Qualifiers
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.
Disqualifiers
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor
Type 1 diabetes mellitus
Age <18 years old
Pregnant or lactating women: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.
Trial design
Treatments tested in this trial
- Sotagliflozin
Treatment groups
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator