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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorNorthwestern University

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 volunteers

Qualifiers

>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

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin 10 MG [Farxiga]

    Drug

    10mg (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

60 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Standard of Care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Left ventricular longitudinal strain (LVLS)

2D-speckle tracking echocardiography

Time frame
6 months
2

Peak VO2 (oxygen consumption)

Cardiopulmonary exercise stress test

Time frame
6 months
3

Circulating plasma metabolite concentrations

Plasma

Time frame
6 months

Secondary outcomes

1

Left Atrial Reservoir Strain (LARS)

2D-STE

Time frame
6 months
2

Right ventricular free wall strain

2D-STE

Time frame
6 Months

Other outcomes

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