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Recruiting Phase 1, Phase 2 NCT05719714

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

Trial Parameters

Condition Chronic Kidney Diseases
Sponsor Northwestern University
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2024-01-16
Completion 2026-03-01
Interventions
Dapagliflozin 10 MG [Farxiga]

Brief 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.

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 signif

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