SONATA HCM (SONATA-HCM)
Study of a Study Medicine for Symptoms in Hypertrophic Cardiomyopathy
Brief description of study
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 of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Obstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy
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Age: 18 years or above
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Gender: All
Inclusion 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 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 Criteria:
- 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.
The purpose of this research study is to learn about changes in symptoms and daily limits in adults with symptomatic hypertrophic cardiomyopathy (HCM) who take a study medicine compared with a placebo. A placebo looks like the study medicine but does not contain any medicine.
Participants will receive either the study medicine or a placebo. The study team will compare how participants’ HCM symptoms and ability to do activities change during treatment. People in the study will continue their usual heart medicines as long as the doses have been stable before joining the study.
Who can participate:
Adults with symptomatic hypertrophic cardiomyopathy (HCM) may be able to participate if they:
- Have HCM with symptoms that limit activity (NYHA class II or III)
- Have a type of HCM that is either obstructive or nonobstructive based on an ultrasound of the heart (echocardiogram) during screening
- Have a normal or near-normal pumping function of the heart at screening
- Have been on stable doses of their usual heart medicines for at least 1 month before screening
- If taking a cardiac myosin inhibitor, have been on a stable dose for at least 3 months before screening and do not plan a dose increase during the study
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