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NCT05139472 · ClinicalTrials.gov registry record · Phase 4
Impact of Empagliflozin on Functional Capacity in Heart Failure with Preserved Ejection Fraction
A Phase 4 study of Diabetes Mellitus and Heart Failure With Preserved Ejection Fraction, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
- 2
- Study locations
NCT05139472 is a Phase 4 study of Diabetes Mellitus and Heart Failure With Preserved Ejection Fraction that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 8 participants, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT05139472, a Phase 4 study of Diabetes Mellitus and Heart Failure With Preserved Ejection Fraction, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
- 2
- Study locations
Study Summary
Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors generally and empagliflozin specifically have shown cardiovascular benefits in patients with heart failure (HF), but the underlying mechanisms remain unclear. Empagliflozin use resulted in lower pulmonary artery diastolic pressures in patients with HF, suggesting a beneficial diuretic effect. Other potential mechanisms include increased blood volume, decreased blood pressure, and changes in sympathetic and neuro-hormonal activation. This study is a single-arm, open label, prospective interventional study of 8 subjects with heart failure with preserved ejection fraction (HFpEF). Before and after 12 weeks of daily empagliflozin, participants with undergo comprehensive invasive exercise testing with a right heart catheter. Our goal is to evaluate the effects of empagliflozin on fitness, assessed by peak VO2, and peak left ventricular filling pressure, assessed by pulmonary capillary pressure at peak exercise.
Conditions Studied
Interventions
- DRUG Empagliflozin 10 MG
Study Locations (2)
Texas
- Institute for Exercise and Environmental Medicine - Dallas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-11-09 |
| Est. Completion | 2024-02-19 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05139472
The ClinicalTrials.gov registry entry for NCT05139472 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,867-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (100% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Diabetes Mellitus appearing as the primary indexed condition, and to 1 intervention - of which Empagliflozin 10 MG is the first listed.
NCT05139472 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05139472 about?
NCT05139472 is a clinical study titled "Impact of Empagliflozin on Functional Capacity in Heart Failure with Preserved Ejection Fraction". Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors generally and empagliflozin specifically have shown cardiovascular benefits in patients with heart failure (HF), but the underlying mechanisms remain unclear. Empagliflozin use resulted in lower pulmonary artery diastolic pressures in patients with ...
What is the current status of trial NCT05139472?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2021-11-09. Estimated completion is 2024-02-19.
What conditions does trial NCT05139472 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Heart Failure With Preserved Ejection Fraction, Heart Failure, Diastolic.
What interventions are being tested in trial NCT05139472?
The interventions under investigation include: Empagliflozin 10 MG (DRUG).
Who is sponsoring clinical trial NCT05139472?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05139472 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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