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NCT05562063 · ClinicalTrials.gov registry record · Phase 4
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
A Phase 4 study, sponsored by Juan Badimon.
- Completed
- Registry status
- Phase 4
- Development phase
- 88
- Enrollment target
NCT05562063: Completed Phase 4 study, sponsored by Juan Badimon.
NCT05562063 is a Phase 4 study that has completed, run by Juan Badimon. The registered enrollment target is 88 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05562063, a Phase 4 study, has completed, sponsored by Juan Badimon.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 88 participants
- Enrollment target
Study 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 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.
Primary Outcome
Changes in Left Ventricular (LV) mass at 6 months compared to baseline
Interventions
- DRUG Placebo
- DRUG Sotagliflozin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2025-06-04 |
| Phase | Phase 4 |
What the finished NCT05562063 record still lists
NCT05562063 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05562063 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05562063 about?
NCT05562063 is a clinical study titled "Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients". 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 SCOR...
What is the current status of trial NCT05562063?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2022-10-26. Estimated completion is 2025-06-04.
What interventions are being tested in trial NCT05562063?
The interventions under investigation include: Placebo (DRUG), Sotagliflozin (DRUG).
Who is sponsoring clinical trial NCT05562063?
This trial is sponsored by Juan Badimon, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05562063's enrollment target sits among peer trials
88 916th of 2000 higher than 1,078 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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