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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 is a Phase 4 study that has completed, run by Juan Badimon. The registered enrollment target is 88 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05562063
The ClinicalTrials.gov registry entry for NCT05562063 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Juan Badimon, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05562063 reports 0 study locations.
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.
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