Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy

ConditionHypertrophic Cardiomyopathy Without Obstruction

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Pennsylvania

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Sotagliflozin
Drug
Sotagliflozin or placebo will be administered to each participant in a cross over study design. Each participant will receive active drug and placebo with randomization of the order in which they receive them.

Treatment groups

26 Participants

are divided into 2 treatment groups

Group A: Placebo first phase, Sotagliflozin second phasePlacebo comparator 1 intervention

Group B: Sotagliflozin first phase, Placebo second phaseActive comparator 1 intervention

Trial outcomes