Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease

• Status: Not yet recruiting
• Trial end date: 2026-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to better understand the effects of a sodium-glucose transport protein 2 inhibitor, dapagliflozin, added on to standard of care on heart and lung function and circulating metabolites (substances created when our bodies break down food, drugs, or its own tissues) in patients with chronic kidney disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwestern University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Treatments: Dapagliflozin

Criteria

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 any 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%)

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 fraction50%

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