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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Chronic Kidney Diseases, Heart Failure With Preserved Ejection Fraction, Kidney Diseases, Heart Failure

In brief

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.

Key facts

Study ID

NCT05719714

Run by

Northwestern University

People needed

18

Starts

2024-01-16

Expected to finish

2026-09-30

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >18 years of age
• eGFR 25-60 ml/min/1,73m2 (eGFR = estimated glomerular filtration rate)
• On stable doses of diuretics and/or angiotensin converting enzyme inhibitor or angiotensin receptor blocker
• 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.

You may not qualify if…

• presence or history of diabetes
• coronary revascularization within the last 6 months
• hemodynamically significant valvular disease
• significant lung disease requiring home oxygen
• angina (chest pain)
• non-revascularized myocardial ischemia
• systolic BP <100 or >180 mmHg
• pregnancy
• clinical heart failure symptoms
• history of systemic disease processes that can cause HFpEF such as amyloidosis or sarcoidosis
• any musculoskeletal or chronic condition that will interfere with completion of cardiac testing
• active cancer
• immunosuppressive therapy
• baseline or pre-exercise echocardiogram demonstrates a reduced ejection fraction < 50%
• currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy
• Hypersensitivity to a SGLT2i
• Pre-existing liver disease
• ALT/AST> 3x normal (ALT = alanine aminotransferase AST = aspartate aminotransferase)
• history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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