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NCT05057806 · ClinicalTrials.gov registry record · Early Phase 1

SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan

A Early Phase 1 study of Heart Failure With Preserved Ejection Fraction and Type2 Diabetes, sponsored by The University of Texas Health Science Center at San Antonio.

Recruiting
Registry status
Early Phase 1
Development phase
30
Enrollment target
2
Study locations

NCT05057806 is a Early Phase 1 study of Heart Failure With Preserved Ejection Fraction and Type2 Diabetes that is actively recruiting participants, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 30 participants, below the 2,288-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT05057806, a Early Phase 1 study of Heart Failure With Preserved Ejection Fraction and Type2 Diabetes, is actively recruiting participants, sponsored by The University of Texas Health Science Center at San Antonio.

RECRUITING
Registry status
Early Phase 1
Development phase
30 participants
Enrollment target
2
Study locations

Study Summary

The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.

Interventions

  • DRUG Placebo
  • DRUG Empagliflozin 25 MG

Study Locations (2)

Texas

  • Texas Diabetes Institute - University Health System - San Antonio
  • University of Texas Health Science Center at San Antonio - San Antonio

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2021-01-13
Est. Completion 2027-03-31
Phase Early Phase 1

What the Registry Record Tells You About NCT05057806

The ClinicalTrials.gov registry entry for NCT05057806 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,288-participant average among 42 other Heart Failure With Preserved Ejection Fraction trials with a reported enrollment target (99% lower). The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Heart Failure With Preserved Ejection Fraction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05057806 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT05057806 about?

NCT05057806 is a clinical study titled "SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan". The study team will examine the effects of SGLT2i (and SGLT2i-induced increases in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercise capacity, and patient-reported functional outcomes.

What is the current status of trial NCT05057806?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2021-01-13. Estimated completion is 2027-03-31.

What conditions does trial NCT05057806 study?

This clinical trial studies the following conditions: Heart Failure With Preserved Ejection Fraction, Type2 Diabetes.

What interventions are being tested in trial NCT05057806?

The interventions under investigation include: Placebo (DRUG), Empagliflozin 25 MG (DRUG).

Who is sponsoring clinical trial NCT05057806?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05057806 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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