Primary Objectives: * Assess the safety and tolerability of sotagliflozin in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Estimate the effects of sotagliflozin on plasma volume changes in hemodynamically stable participants with worsening of heart failure, compared to placebo. Secondary Objectives: * Explore the effect of sotagliflozin on erythropoiesis, as assessed by changes in plasma erythropoietin levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo. * Explore the effect of sotagliflozin on changes in plasma N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, in hemodynamically stable participants with worsening of heart failure, compared to placebo.
The total study duration will be approximately 27-40 days, including a screening period of 1-10 days, a treatment period of 14 days, and a follow-up period of 14±2 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Pharmaceutical form: Tablet; Route of administration: Oral
Pharmaceutical form: Tablet; Route of administration: Oral
Investigational Site Number 8400005
La Jolla, California, United States
Investigational Site Number 8400001
New Haven, Connecticut, United States
Investigational Site Number 8400007
Rochester, Minnesota, United States
Investigational Site Number 8400002
Cleveland, Ohio, United States
Investigational Site Number 1240001
Toronto, Canada
Investigational Site Number 5280001
Groningen, Netherlands
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs), AEs Leading to Discontinuation From the Investigational Medicinal Product (IMP) and Deaths
AE: is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. SAEs: an event that results in death; an event that, in the view of the investigator, places the participants at immediate risk of death (a life-threatening event); an outcome that results in a congenital anomaly/birth defect diagnosed in a child of a participant; an event that requires or prolongs inpatient hospitalization; an event that results in persistent or significant disability/incapacity. AESI: is an adverse event (serious or nonserious) of scientific and medical concern, specific to the IMP or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor may be appropriate.
Time frame: Baseline up to Day 14
Change From Baseline in Hemoconcentration as Assessed by Changes in Albumin to Day 14
Time frame: Baseline to Day 14
Change From Baseline in Hemoconcentration as Assessed by Changes in Hematocrit to Day 14
Time frame: Baseline to Day 14
Change From Baseline in Hemoconcentration as Assessed by Changes in Hemoglobin to Day 14
Time frame: Baseline to Day 14
Change From Baseline in Hemoconcentration as Assessed by Changes in Total Protein to Day 14
Time frame: Baseline to Day 14
Changes From Baseline in Plasma Volume to Day 14
Change in plasma volume in milliliters (mL) was assessed by the indicator dilution method using 131I-labelled human albumin.
Time frame: Baseline to 14 Days
Change From Baseline in Erythropoietin to Day 14
Change in erythropoietin international units per liter (IU/L) was measured by chemiluminescent enzyme-labelled immunometric assay.
Time frame: Baseline to Day 14
Change From Baseline in N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) to Day 14
Change in NT-proBNP picomoles per liter (pmol/L) was measured by standard electrochemiluminescence immunoassay.
Time frame: Baseline to Day 14
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