Investigating Sotagliflozin for Heart Failure with Preserved Ejection Fraction
SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes
This study is testing if a new medication called sotagliflozin can help people with heart failure and preserved ejection fraction feel better and improve their heart and kidney health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05562063 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, on patients with heart failure and preserved ejection fraction (HFpEF). It aims to explore the potential cardio-renal benefits of sotagliflozin in a randomized, double-blind, placebo-controlled design. The study includes ambulatory patients aged 18 and older who do not have diabetes and have stable heart failure symptoms. The trial will assess the drug's impact on heart failure-related outcomes and its mechanisms of action.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults aged 18 and older with a diagnosis of heart failure (NYHA II to III) and preserved ejection fraction.
Not a fit: Patients with diabetes, acute coronary syndrome, or those recently hospitalized for heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with HFpEF, potentially improving their heart failure outcomes.
How similar studies have performed: Previous studies have shown positive outcomes with sotagliflozin in related populations, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: patients should meet all of the following criteria * Ambulatory patients age ≥ 18 years * Written informed consent prior to admission to the trial. * No diabetes as confirmed by HbA1c \<6.5%, fasting serum glucose \<126 mg/dL, and review of concomitant medications and medical history * Diagnosis of Heart failure (NYHA II to III) * LVEF \> 50% * On medical therapy for heart failure consistent with prevailing cardiovascular guidelines at a stable dose for ≥4 weeks prior to screening, except for diuretics which must have been stable for ≥2 weeks prior to screening * Women of child-bearing potential must agree to use birth control measures with a failure rate of \<1% per year during the treatment period of the study Exclusion Criteria: * Type 1 and Type 2 diabetes * Acute coronary syndrome (ACS) or cardiac surgery within the last week. * Pregnant or lactating women, * Acute decompensated HF or hospitalized for HF within 1 month from screening visit * Glomerular Filtration Rate (GFR) \< 25 ml/ min/1.73m2, * Patients on drugs with potential interaction with sotagliflozin including digoxin, phenytoin, HIV medication and rifampin. * Receiving SGLT2-I 3-months prior to randomization. * non-MRI compatible PM or ICD and any other medical or physical condition considered unappropriated by a study physician.
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Juan J Badimon — Icahn School of Medicine at Mount Sinai
- Study coordinator: Juan J Badimon
- Email: Juan.Badimon@mssm.edu
- Phone: (212) 241-8484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.