About this trial
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
This trial does not accept healthy volunteersQualifiers
>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.
Disqualifiers
presence or history of diabetes
coronary revascularization within the last 6 months
hemodynamically significant valvular disease
significant lung disease requiring home oxygen
Trial design
Parallel
Treatments tested in this trial
Dapagliflozin 10 MG [Farxiga]
Drug10mg (milligram) tablet to be taken orally once daily for 6 months. Manufacturer: Astrazeneca. Study drug will be stored and dispensed by the Interventional Drug Service Pharmacy at Northwestern University.
Treatment groups
Trial outcomes
Primary outcomes
Left ventricular longitudinal strain (LVLS)
2D-speckle tracking echocardiography
Peak VO2 (oxygen consumption)
Cardiopulmonary exercise stress test
Circulating plasma metabolite concentrations
Plasma
Secondary outcomes
Left Atrial Reservoir Strain (LARS)
2D-STE
Right ventricular free wall strain
2D-STE
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Northwestern University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator