Effects of Dapagliflozin on Heart and Kidney Function
Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease
This study is testing if the drug dapagliflozin can improve heart and kidney function in people with chronic kidney disease and early signs of heart failure.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05719714 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to explore how dapagliflozin, a sodium-glucose transport protein 2 inhibitor, affects heart and lung function as well as metabolite levels in patients with chronic kidney disease and signs of subclinical heart failure. Over six months, sixty participants will be randomized to receive either dapagliflozin or standard care, with assessments of cardiac function and metabolomics conducted at the beginning and end of the study. The research focuses on understanding the relationship between metabolomic changes induced by dapagliflozin and improvements in cardiac performance as measured by echocardiography and exercise testing.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic kidney disease and evidence of subclinical heart failure.
Not a fit: Patients with a history of diabetes or recent coronary revascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with chronic kidney disease and heart failure.
How similar studies have performed: Other studies have shown promising results with SGLT2 inhibitors in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Chicago, Illinois
- Northwestern University — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Rupal Mehta, MD — Northwestern Univeristy
- Study coordinator: Rupal Mehta, MD
- Email: rupal.mehta@northwestern.edu
- Phone: (312) 503-1536
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.