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Tests treatment safety and results for Obstructive Cardiomyopathy, Hypertrophic
Official title A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
ClinicalTrials.gov ID: NCT06481891
What this study is testing
What is Sotagliflozin?
Sotagliflozin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for obstructive cardiomyopathy, hypertrophic.
Also referred to as SAR439954/LX4211.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For obstructive hypertrophic cardiomyopathy (oHCM), left ventricular outflow tract (LVOT) peak gradient ≥ 30 millimetre of mercury (mm Hg) during...
- For nonobstructive hypertrophic cardiomyopathy (nHCM), LVOT peak gradient \< 30 mm Hg during screening as assessed by echocardiography at rest and \<...
You likely can't join if
- 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 treatment clinical trial or prior participation in any treatment trial with an investigational agent within...
- Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM such as Fabry disease, amyloidosis, or Noonan syndrome with LV...
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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 treatment clinical trial or prior participation in any treatment 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Pomona, California, United States
- San Francisco, California, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Evanston, Illinois, United States
- Merrillville, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Morristown, New Jersey, United States
- Manhasset, New York, United States
- New York, New York, United States
- Morrisville, North Carolina, United States
+ 73 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; Pomona, California, United States; San Francisco, California, United States; Jacksonville, Florida, United States and 87 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.