Trial · NCT05562063
Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
NCT05562063, Phase 4, Completed, Juan Badimon
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients. Trials, record NCT05562063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05562063
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
- NCT number
- NCT05562063
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 88 participants, actual
- Lead sponsor
- Juan Badimon
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Interventions
- Sotagliflozin, Placebo
- First posted
- 2022-09-30
- Last updated
- 2026-06-24
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Left Ventricular Mass in CMRI | Baseline and 6 months | Changes in Left Ventricular (LV) mass at 6 months compared to baseline |
| Secondary | Changes in Left Ventricular End-systolic Volume | Baseline and 6 months | Changes in left ventricular end-systolic volume (LVESV) in CMRI at 6 months compared to baseline |
| Secondary | Changes in Left Ventricular End-diastolic Volume | Baseline and 6 months | Changes in left ventricular end-diastolic volume (LVEDV) in CMRI at 6 months compared to baseline |
| Secondary | Changes in Extracellular Volume (ECV) | 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 |
| Secondary | Changes in Left Atrial Volume Index | Baseline and 6 months | Changes in Left atrial volume index measured by CMRI at 6 months compared to baseline |
| Secondary | Changes in Peak Oxygen Consumption (peakVO2) | 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 |
| Secondary | Changes 6 Minute Walk Test | 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 |
| Secondary | Changes in The Kansas City Cardiomyopathy Questionnaire (KCCQ) | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37318685 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05562063
GET https://conductscience.org/api/trials/v1/NCT05562063/registered