Actively Recruiting
Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
Led by University of Pennsylvania · Updated on 2026-02-11
26
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least 18 years, both sexes
- Signed and dated informed consent form provided
- Willingness to follow all study procedures and available for the study duration
- Ability to take oral medication and willing to adhere to study treatment
- For females able to have children: use highly effective contraception for at least 1 month before screening and during the study plus 2 weeks after stopping study drug
- Diagnosis of hypertrophic cardiomyopathy with NYHA Class II-III symptoms or NYHA Class I with low peak oxygen consumption on exercise test
- Left ventricular outflow tract gradient less than 50 mmHg at rest, with valsalva, and during exercise
- Left ventricular ejection fraction over 50% by recent echocardiogram or cardiac MRI
- Stable medical treatment for at least 1 month before joining the study
You will not qualify if you...
- Use of SGLT2 inhibitor treatment within 8 weeks before study or known intolerance to such drugs
- Having type 1 diabetes
- Age under 18 years
- Pregnancy or breastfeeding
- Uncontrolled atrial fibrillation with resting heart rate over 100 beats per minute
- Plans to restore normal heart rhythm for atrial fibrillation or flutter during the study
- Unable to reach required respiratory exchange ratio during exercise test
- Septal reduction therapy in past 3 months
- Planned implant of defibrillator during study
- Recent or planned cardiac resynchronization therapy device implant
- Hemoglobin less than 10 g/dL
- Severe kidney disease or unstable worsening kidney function
- Unable or unwilling to exercise
- Significant left or right-sided heart valve disease
- Current angina due to significant coronary artery disease
- Recent heart attack or coronary procedure within 2 months
- Primary pulmonary arterial hypertension
- Severe lung disease or recent oral steroid use for lung problems
- Significant ischemia on stress testing without proper follow-up
- Symptomatic slow heart rate or advanced heart block without pacemaker
- Serious liver disease affecting function
- Severe right ventricular dysfunction on heart ultrasound
- Large drop in blood pressure upon standing
- Participation in another trial with investigational agents
- Any condition that could prevent completing the study, including other health or logistical issues
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
S
Sharlene Day, MD
CONTACT
K
Kim Clinton
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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