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

Launched by NORTHWESTERN UNIVERSITY · Jan 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called dapagliflozin, which helps lower blood sugar levels, affects heart and lung function in patients with chronic kidney disease. Researchers want to see how this drug, when added to the usual treatment, impacts certain substances in the body and the way the heart works. The goal is to find out if dapagliflozin can help improve the health of patients who also have heart issues, specifically heart failure with preserved ejection fraction, which means the heart can still pump blood effectively but has other problems.

To participate in this study, individuals need to be at least 18 years old and have specific kidney function levels. They should also be on stable doses of certain heart medications and have signs of mild heart failure. However, people with diabetes, significant heart or lung disease, recent heart procedures, or certain other health conditions won’t be eligible. Participants can expect to undergo various tests to evaluate their heart and lung function, and they will be closely monitored throughout the trial. This study is currently recruiting participants, and it aims to provide valuable insights into better managing heart and kidney health together.

Gender

ALL

Eligibility 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