NCT05719714 · Northwestern University
Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease
What this study is about
The goal of this study is to better understand the effects of a sodium-glucose transport protein 2 inhibitor, dapagliflozin, added on to the usual treatment 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.
View original scientific description
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.
Interventions
DRUG
Dapagliflozin 10 MG [Farxiga]
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.
Primary outcome measures
Left ventricular longitudinal strain (LVLS)
Time frame: 6 months
2D-speckle tracking echocardiography
Peak VO2 (oxygen consumption)
Time frame: 6 months
Cardiopulmonary exercise stress test
Circulating plasma metabolite concentrations
Time frame: 6 months
Plasma
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \>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.
Exclusion criteria
- 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
- 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
- Chicago, Illinois
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations