Kidney Drug's hidden heart benefits under the microscope
NCT ID NCT05719714
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study looks at how dapagliflozin, a diabetes drug, affects heart function and metabolism in people with chronic kidney disease. Researchers will measure heart strain, oxygen use during exercise, and blood chemicals in 60 adults. The goal is to understand how the drug works beyond its usual effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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18 people
The number who actually took part.
- Started
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Jan 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. \>18 years of age 2. eGFR 25-60 ml/min/1,73m2 (eGFR = estimated glomerular filtration rate) 3. On stable doses of diuretics and/or angiotensin converting enzyme inhibitor or angiotensin receptor blocker 4. Evidence of subclinical heart failure with preserved ejection fraction at their pre-exercise echocardiogram (defined as meeting 3/5 of the American Society of Echocardiography (ASE) criteria for diastolic dysfunction \[septal e'\<7 cm/wc, average E/e' ratio\>14, left atrial volume index \>34 mL/m2, and peak TR velocity \>2.8 m/sec\] or absolute left ventricular longitudinal strain \< 18%, left atrial reservoir strain (LARS) \< 25% on 2d speckle tracking echocardiography), lack of augmentation of LVLS or LARS during exercise, or peak VO2 Females: ≤ 18 mL/kg/min, peak VO2 Males: ≤ 20 mL/kg/min on cardiopulmonary exercise testing. Exclusion Criteria: 1. presence or history of diabetes 2. coronary revascularization within the last 6 months 3. hemodynamically significant valvular disease 4. significant lung disease requiring home oxygen 5. angina (chest pain) 6. non-revascularized myocardial ischemia 7. systolic BP \<100 or \>180 mmHg 8. pregnancy 9. clinical heart failure symptoms 10. history of systemic disease processes that can cause HFpEF such as amyloidosis or sarcoidosis 11. any musculoskeletal or chronic condition that will interfere with completion of cardiac testing 12. active cancer 13. immunosuppressive therapy 14. baseline or pre-exercise echocardiogram demonstrates a reduced ejection fraction \< 50% 15. currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy 16. Hypersensitivity to a SGLT2i 17. Pre-existing liver disease 18. ALT/AST\> 3x normal (ALT = alanine aminotransferase AST = aspartate aminotransferase) 19. history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Northwestern University
Chicago, Illinois, 60607, United States
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Other studies related to the condition(s) this trial covers.
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