Heart Failure With Preserved Ejection FractionPhase 4NCT05562063
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
A Phase 4 study testing Sotagliflozin in people with Heart Failure With Preserved Ejection Fraction, run by Juan Badimon at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Sotagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2022to 4 Jun 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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.
- Being tested
- Sotagliflozin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotagliflozinDrug
Daily administration of sotagliflozin (2x200 mg, PO, OD) for 6 months.
PlaceboDrug
Matching placebo for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Sotagliflozin | Experimental | Daily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months. Receives: Drug: Sotagliflozin |
| Placebo | Placebo comparator | Daily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Left Ventricular Mass in CMRI
Changes in Left Ventricular (LV) mass at 6 months compared to baseline
Measured: Baseline and 6 months
Secondary outcomes (7)
Changes in Left Ventricular End-systolic Volume
Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline
Measured: Baseline and 6 months
Changes in Left Ventricular End-diastolic Volume
Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline
Measured: Baseline and 6 months
Changes in Extracellular Volume (ECV)
Changes in extracellular volume (ECV) to assess Left Ventricular interstitial myocardial fibrosis as quantified using T1 mapping at 6 months compared to baseline
Measured: Baseline and 6 months
Changes in Left Atrial Volume Index
Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline
Measured: Baseline and 6 months
Changes in Peak Oxygen Consumption (peakVO2)
Changes in exercise capacity as assessed by peak oxygen consumption in Cardiopulmonary exercise test (CPET) at 6 months compared to baseline
Measured: Baseline and 6 months
Changes 6 Minute Walk Test
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
Measured: Baseline and 6 months
Changes in The Kansas City Cardiomyopathy Questionnaire (KCCQ)
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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start26 Oct 2022
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Juan Badimon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Juan Badimon, Icahn School of Medicine at Mount Sinai
- Investigators
- Juan J Badimon, Principal investigator, Icahn School of Medicine at Mount SinaiCarlos G Santos-Gallego, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562063
- Sponsor's protocol ID
- GCO-22-0574
- Status last verified
- Jul 2025
- First submitted
- 27 Sep 2022
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Perez MS, Rodriguez-Capitan J, Requena-Ibanez JA, Santos-Gallego CG, Urooj Zafar M, Escolar G, Mancini D, Mitter S, Lam D, Contreras JP, Fergus I, Atallah-Lajam F, Abascal V, Lala A, Moreno P, Moss N, Lerakis S, Sanz J, Fuster V, Badimon JJ. Rationale and Design of the SOTA-P-CARDIA Trial (ATRU-V): Sotagliflozin in HFpEF Patients Without Diabetes. Cardiovasc Drugs Ther. 2025 Feb;39(1):155-164. doi: 10.1007/s10557-023-07469-6. Epub 2023 Jun 15.
PubMed 37318685
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOTA-P-CARDIA Trial: A Randomized Trial of Sotagliflozin in HFpEF Patients Without Diabetes
- ClinicalTrials.gov ID
- NCT05562063
- Acronym / sponsor ID
- GCO-22-0574
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Juan BadimonUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 30 Sep 2022 (actual)
- Results
- Posted 24 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sotagliflozin | Experimental | Drug: SotagliflozinDaily administration of sotagliflozin (2x200 mg, orally, once a day) for 6 months. |
| Placebo | Placebo comparator | Drug: PlaceboDaily administration of placebo (2 tablet identical in appearance and color to sotagliflozin tablets, orally, once a day) for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotagliflozinDaily administration of sotagliflozin (2x200 mg, PO, OD) for 6 months. | Drug | Sotagliflozin |
| PlaceboMatching placebo for 6 months. | Drug | Placebo |
Primary outcome
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
7 secondary outcomes
Changes in Left Ventricular End-systolic Volume
Time frame: Baseline and 6 months
Changes in Left Ventricular End-diastolic Volume
Time frame: Baseline and 6 months
Changes in Extracellular Volume (ECV)
Time frame: Baseline and 6 months
Changes in Left Atrial Volume Index
Time frame: Baseline and 6 months
Changes in Peak Oxygen Consumption (peakVO2)
Time frame: Baseline and 6 months
Changes 6 Minute Walk Test
Time frame: Baseline and 6 months
Changes in The Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37318685Perez MS, Rodriguez-Capitan J, Requena-Ibanez JA, Santos-Gallego CG, Urooj Zafar M, Escolar G, Mancini D, Mitter S, Lam D, Contreras JP, Fergus I, Atallah-Lajam F, Abascal V, Lala A, Moreno P, Moss N, Lerakis S, Sanz J, Fuster V, Badimon JJ. Rationale and Design of the SOTA-P-CARDIA Trial (ATRU-V): Sotagliflozin in HFpEF Patients Without Diabetes. Cardiovasc Drugs Ther. 2025 Feb;39(1):155-164. doi: 10.1007/s10557-023-07469-6. Epub 2023 Jun 15.
- Individual participant dataSharing planned: No. Undecided: It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan J Badimon principal investigator
Icahn School of Medicine at Mount Sinai
Carlos G Santos-Gallego, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sotagliflozin in people with Heart Failure With Preserved Ejection Fraction, run by Juan Badimon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Left Ventricular Mass in CMRI (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.