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

May 28, 2026 updated by: Juan Badimon

SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: patients should meet all of the following 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sotagliflozin
Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months.
Drug: Sotagliflozin
Daily administration of sotagliflozin (2x200 mg, PO, OD) 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.
Drug: Placebo
Matching placebo for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Left Ventricular Mass in CMRI
Time Frame: Baseline and 6 months
Changes in Left Ventricular (LV) mass at 6 months compared to baseline
Baseline and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in The Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 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.
Baseline and 6 months
Changes in Left Ventricular End-systolic Volume
Time Frame: Baseline and 6 months
Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline
Baseline and 6 months
Changes in Left Ventricular End-diastolic Volume
Time Frame: Baseline and 6 months
Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline
Baseline and 6 months
Changes in Extracellular Volume (ECV)
Time Frame: 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
Baseline and 6 months
Changes in Left Atrial Volume Index
Time Frame: Baseline and 6 months
Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline
Baseline and 6 months
Changes in Peak Oxygen Consumption (peakVO2)
Time Frame: 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
Baseline and 6 months
Changes 6 Minute Walk Test
Time Frame: 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
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juan Badimon

Investigators

  • Principal Investigator: Juan J Badimon, Icahn School Of Medicine At Mount Sinai
  • Principal Investigator: Carlos G Santos-Gallego, MD, Icahn School Of Medicine At Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2022

Primary Completion (Actual)

June 4, 2025

Study Completion (Actual)

June 4, 2025

Study Registration Dates

First Submitted

September 27, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 30, 2022

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO-22-0574

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Undecided: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe