NCT05562063CompletedPhase 4
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
The clinical benefits of the dual Sodium-Glucose cotransporter (SGLT) 1 and 2-inhibition have recently been reported in two clinical trials. The SOLOIST reported the benefits of sotagliflozin in Type-2 Diabetes Mellitus (T2DM) patients hospitalized for worsening of Heart Failure (HF), while the SCORED involved T2DM patients with Chronic Kidney Disease (CKD). It is worth noting that not only did the event curves separate within the first week post-treatment, but the effects of sotagliflozin on HF-related outcomes were observed regardless of Left Ventricular Ejection Fraction (LVEF) values and did not seem to attenuate with increasing LVEF as seen with empagliflozin and sacubitril/valsartan. Despite the favorable outcomes, the mechanism(s) of action through which sotagliflozin exerts these benefits remains unclear. The present study aims to investigate the potential (non-glucose dependent) "cardio-renal" pleiotropic effects of sotagliflozin in a mechanistic, randomized, double blind, placebo-control trial in HF patients with preserved ejection fraction (HFpEF). Comparisons between treatment groups will be made using cardiac MRI, CPET, 6-MWT and KCCQ-12.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 27 Sept 2022
- Start date
- 26 Oct 2022
- Primary completion date
- 4 Jun 2025
- Lead sponsor
- Juan Badimon
- Diseases
- Heart failure
- NCT number
- NCT05562063
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 88
- From 26 Oct 2022 to the primary completion date, 4 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving SGLT2-I 3-months prior to randomization.
Other illness
- Type 1 and Type 2 diabetes
- Acute coronary syndrome (ACS) or cardiac surgery within the last week.
- Patients on drugs with potential interaction with sotagliflozin including digoxin, phenytoin, HIV medication and rifampin.
- non-MRI compatible PM or ICD and any other medical or physical condition considered unappropriated by a study physician.
Lab values
- Glomerular Filtration Rate (GFR) \< 25 ml/ min/1.73m2,
Other
- Pregnant or lactating women,
- Acute decompensated HF or hospitalized for HF within 1 month from screening visit
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.