SGLT2 Inhibitors, Ketones, and Cardiovascular Benefit Research Plan
NCT ID: NCT05057806
Last Updated: 2025-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2021-01-13
2027-03-31
Brief Summary
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Detailed Description
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(i) Skeletal muscle bioenergetics. Using 31P-MRS, the team will quantitate phosphocreatine \[PCr\], ATP, inorganic phosphate, phosphodiester, and intracellular pH. With 1H-MRS, and will measure intramyocellular lipid content at rest and ATPmax production after exercise. The team will examine the relationships between phosphorous metabolite concentrations, intramyocellular lipid content, and ATP generation before and after 12 weeks of SGLT2 inhibition.
(ii) Cardiopulmonary functional capacity.
(iii) Improvements in Patient-Reported Outcomes (PRO). The Patient-Reported Outcomes Measure Information System (PROMIS) Item Bank v2.0 - Physical Function - Short Form 20a will be used to evaluate self-reported physical function and well-being. This tool is a well-developed and validated method to obtain patient self-reported parameters of health in adults.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Empagliflozin Group
Subjects will be randomized 2:1 to receive empagliflozin, 25mg/day for 3 months
Empagliflozin 25 MG
Empagliflozin 25MG will be administered orally once per day for 3 months
Placebo group
Subjects will be randomized to receive the empagliflozin placebo for 3 months
Placebo
The placebo will be administered orally once per day for 3 months
Interventions
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Empagliflozin 25 MG
Empagliflozin 25MG will be administered orally once per day for 3 months
Placebo
The placebo will be administered orally once per day for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Class II-III New York Heart Association (NYHA) heart failure and reduced ejection fraction (EF) \<50%
* Age 18-80 years
* BMI 23-38 kg/m2
* Glycated hemoglobin (HbA1c) 5.5-10%
* Blood Pressure (BP) ≤ 145/85 mmHg
* Estimated glomerular filtration rate (eGFR) ≥30 ml/min•1.73 m2
* Stable dose of guideline-directed medications for heart failure and Diabetes
* Stable body weight (±4 pounds) over the last 3 months
* Does not suffer from severe claustrophobia
* No contraindication for MRI (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
Exclusion Criteria
* Pregnancy, lactation or plans to become pregnant
* Allergy/sensitivity to study drugs or their ingredients
* Cancer
* Current drug or alcohol use or dependence
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent
18 Years
80 Years
ALL
No
Sponsors
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Doris Duke Charitable Foundation
OTHER
Max and Minnie Tomerlin Voelcker Fund
UNKNOWN
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Carolina Solis-Herrera, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center San Antonio
Locations
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Texas Diabetes Institute - University Health System
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021176
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HSC20210528H
Identifier Type: -
Identifier Source: org_study_id
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