Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients

NCT ID: NCT05562063

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-26
• Study Completion Date: 2025-06-04

Brief Summary

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sotagliflozin

Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.

Group Type: EXPERIMENTAL

Sotagliflozin

Intervention Type: DRUG

Daily administration of sotagliflozin (2x200 mg, PO, OD) for 6 months.

Placebo

Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo for 6 months.

Interventions

Sotagliflozin

Daily administration of sotagliflozin (2x200 mg, PO, OD) for 6 months.

Intervention Type: DRUG

Placebo

Matching placebo for 6 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juan Badimon

OTHER

Sponsor Role: lead

Responsible Party

Juan Badimon

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Juan J Badimon

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Carlos G Santos-Gallego, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO-22-0574

Identifier Type: -

Identifier Source: org_study_id