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

Part of paid clinical trials in New York, New York.

Sponsor
Juan Badimon
Study ID
NCT05562063
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sotagliflozin — DRUG
    Daily administration of sotagliflozin (2x200 mg, PO, OD) for 6 months.
  • Placebo — DRUG
    Matching placebo for 6 months.

Study Details

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.

Key Dates

Start date
Oct 26, 2022
Status verified
Jul 2025
Primary completion
Jun 4, 2025
Completion
Jun 4, 2025

Study Design

Enrollment
88 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sotagliflozin
    Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.
  • Placebo Comparator: Placebo
    Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.

Primary Outcome Measure

Changes in Left Ventricular mass in CMRI [ Time Frame: Baseline and 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in New York, NY

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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