Trial Outcomes & Findings for Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients (NCT NCT05562063)

NCT ID: NCT05562063

Last Updated: 2026-06-24

Results Overview

Changes in Left Ventricular (LV) mass at 6 months compared to baseline

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

88 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2026-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Sotagliflozin Daily administration of sotagliflozin (2x200 mg, orally, once a day) 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.
Overall Study STARTED	44	44
Overall Study COMPLETED	39	37
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Sotagliflozin Daily administration of sotagliflozin (2x200 mg, orally, once a day) 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.
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	1	0
Overall Study withdrew consent prior to intervention	2	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sotagliflozin n=44 Participants Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.	Placebo n=44 Participants Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.	Total n=88 Participants Total of all reporting groups
Race (NIH/OMB) White	8 Participants n=20 Participants	2 Participants n=20 Participants	10 Participants n=40 Participants
Age, Continuous	76.8 years STANDARD_DEVIATION 10.9 • n=20 Participants	76 years STANDARD_DEVIATION 8.1 • n=20 Participants	76.4 years STANDARD_DEVIATION 9.6 • n=40 Participants
Sex: Female, Male Female	31 Participants n=20 Participants	31 Participants n=20 Participants	62 Participants n=40 Participants
Sex: Female, Male Male	13 Participants n=20 Participants	13 Participants n=20 Participants	26 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=20 Participants	28 Participants n=20 Participants	58 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=20 Participants	16 Participants n=20 Participants	30 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	10 Participants n=20 Participants	13 Participants n=20 Participants	23 Participants n=40 Participants
Race (NIH/OMB) More than one race	26 Participants n=20 Participants	28 Participants n=20 Participants	54 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Changes in Left Ventricular (LV) mass at 6 months compared to baseline

Outcome measures

Outcome measures
Measure	Sotagliflozin n=38 Participants Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.	Placebo n=34 Participants Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.
Changes in Left Ventricular Mass in CMRI	-8.6 grams Interval -11.9 to -5.3	5.7 grams Interval 2.1 to 9.2

SECONDARY outcome

Timeframe: Baseline and 6 months

Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline

Outcome measures

Outcome measures
Measure	Sotagliflozin n=38 Participants Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.	Placebo n=34 Participants Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.
Changes in Left Ventricular End-systolic Volume	-6.3 mL Interval -9.3 to -3.2	0.1 mL Interval -3.1 to 3.3

SECONDARY outcome

Timeframe: Baseline and 6 months

Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline

Outcome measures

Outcome measures
Measure	Sotagliflozin n=38 Participants Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.	Placebo n=34 Participants Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months.
Changes in Left Ventricular End-diastolic Volume	1.7 mL Interval -7.8 to 4.3	0.3 mL Interval -6.7 to 6.0

SECONDARY outcome

Timeframe: Baseline and 6 months

Changes in extracellular volume (ECV) to assess Left Ventricular interstitial myocardial fibrosis as quantified using T1 mapping at 6 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 6 months

Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 6 months

Changes in exercise capacity as assessed by peak oxygen consumption in Cardiopulmonary exercise test (CPET) at 6 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 6 months

Changes in exercise tolerance as assessed by 6 minute walk test, or the distance covered over a time of 6 minutes, at 6 months compared to baseline

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 6 months

Changes in The KCCQ at 6 months compared to baseline. The KCCQ is the most widely used instrument to evaluate quality of life in Heart Failure (HF). The KCCQ is a 12-item self-administered questionnaire used to measure the patient's perception of their health status. The KCCQ is a disease-specific health status instrument composed of 12 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Full scale range is from 0 to 100; higher scores reflect better health status.

Outcome measures

Outcome data not reported

Adverse Events

Sotagliflozin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Juan Badimon

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-8484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place