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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• \>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.

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Rupal Mehta, MD
rupal.mehta@northwestern.edu
(312) 503-1536
Backup
Tamara Isakova, MD
tamara.isakova@northwestern.edu
(312) 503-6921
Time Frame
Start Date: 2024-01-16
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 60
Treatments
Experimental: Intervention group
Thirty individuals will be randomized to dapagliflozin 10mg to be taken daily for six months.
No_intervention: Standard of Care group
Thirty individuals will be randomized to standard of care treatment.
Sponsors
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Leads: Northwestern University

This content was sourced from clinicaltrials.gov

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