Sotagliflozin in Symptomatic Obstructive And Non-Obstructive Hypertrophic Cardiomyopathy

What is the Purpose of this Study?

The purpose of this study is to determine whether an experimental drug called sotagliflozin is effective in treating symptoms related to hypertrophic cardiomyopathy (HCM). HCM is a common heart condition that causes the heart muscle to thicken and can trigger irregular heartbeats and heart failure. Sotagliflozin controls blood sugar by slowing gut absorption and boosting helpful hormones. In the kidneys, it blocks glucose (blood sugar), leading to calorie loss and potentially lowering blood pressure; this may indirectly ease heart stress. Thus, the drug can potentially be used for HCM treatment. In addition to examining whether sotagliflozin is effective in treating HCM-related symptoms, researchers will evaluate how well the drug is tolerated and its side effects. Study procedures include echocardiograms, ECGs, questionnaires, and blood/urine testing. Participants will be randomly assigned by chance to receive either sotagliflozin or placebo (inactive substance). Sotagliflozin is approved by the U.S. Food and Drug Administration (FDA) for a heart failure related indication; however, its use is considered experimental in this study of patients with hypertrophic cardiomyopathy.


Eligibility

  • * KCCQ CSS \< 85.
  • * NYHA functional class II or III
  • * A diagnosis of HCM consistent with the current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guideline definition: unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease with maximal LV wall thickness ≥ 15 millimeters (mm), or ≥ 13 mm with positive family history of HCM.
  • * For obstructive hypertrophic cardiomyopathy (oHCM), left ventricular outflow tract (LVOT) peak gradient ≥ 30 millimetre of mercury (mm Hg) during screening as assessed by echocardiography at rest or during a valsalva maneuver.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of SOtaglifloziN in symptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy

Study Details
Disease Type/Condition

Other

Principal Investigator

Rader, Florian

Age Group

Adult

Phase

III

IRB Number

STUDY00003552

ClinicalTrials.gov ID

NCT06481891

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Rader, Florian

Age Group

Adult

Phase

III

IRB Number

LX4211-1-314-HCM

ClinicalTrials.gov ID

NCT06481891

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org