RecruitingPhase 3NCT06481891
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
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 (SONATA-HCM)
Sponsor
Lexicon Pharmaceuticals
Enrollment
500 participants
Start Date
Sep 24, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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.
- For nonobstructive hypertrophic cardiomyopathy (nHCM), LVOT peak gradient \< 30 mm Hg during screening as assessed by echocardiography at rest and \< 30 mm Hg during a valsalva maneuver.
- Screening left ventricular ejection fraction (LVEF) ≥ 50%, except for those on a cardiac myosin inhibitor (screening LVEF ≥ 55%).
- For participants on a cardiac myosin inhibitor, the dose must be stable at least 3 months prior to screening. Participants on cardiac myosin inhibitor should not be scheduled for up-titration during the trial.
- Stable doses of background therapy (ie, β-blockers, calcium channel blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers, diuretics) for at least 1 month prior to screening.
Exclusion Criteria17
- Received therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within the past 8 weeks prior to screening.
- Previous intolerance to an SGLT2 inhibitor.
- Any previous treatment with sotagliflozin.
- Current use of thiazolidinediones or digoxin.
- Current/planned participation in another interventional clinical trial or prior participation in any interventional trial with an investigational agent within 45 days of screening.
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM such as Fabry disease, amyloidosis, or Noonan syndrome with LV hypertrophy.
- History of unexplained syncope within 6 months prior to screening.
- History of sustained ventricular tachyarrhythmia (\> 30 seconds) or appropriate implantable cardioverter defibrillator (ICD) discharge within 6 months prior to screening.
- Has paroxysmal, persistent, or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate controlled within 3 months of screening.
- Septal reduction therapy planned during the study period. For participants who had septal reduction therapy, the procedure should have been completed more than 3 months prior to screening.
- Cardiac surgery (eg, coronary artery bypass graft, valvular repair/replacement), percutaneous coronary intervention, or implantation of cardiac device (pacemaker or implantable cardioverter defibrillator) within 3 months prior to screening or planned during the study period.
- Presence of a cardiac resynchronization therapy device.
- Acute coronary syndrome within 2 months prior to screening.
- History of stroke or myocardial infarction within 6 months prior to screening.
- Hospitalization for heart failure or arrhythmia within 4 weeks prior to screening.
- Has known moderate or severe (as per investigator's judgment) aortic valve stenosis at screening.
- Current angina or clinically significant ischemia due to unstable epicardial coronary disease, as per investigator judgment.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGSotagliflozin
Sotagliflozin will be administered as a tablet(s), orally once daily.
DRUGPlacebo
Placebo will be administered as a tablet(s) (identical to the sotagliflozin tablet in appearance), orally once daily.
Locations(107)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06481891
Related Trials
A Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy
NCT0702361423 locations
Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy
NCT055693824 locations
A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy
NCT068162511 location