RECRUITING

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

Conditions

Chronic Kidney Diseases Heart Failure With Preserved Ejection Fraction Kidney Diseases Heart Failure kidney

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-16

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05719714

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	1. presence or history of diabetes 2. coronary revascularization within the last 6 months 3. hemodynamically significant valvular disease 4. significant lung disease requiring home oxygen 5. angina (chest pain) 6. non-revascularized myocardial ischemia 7. systolic BP \<100 or \>180 mmHg 8. pregnancy 9. clinical heart failure symptoms 10. history of systemic disease processes that can cause HFpEF such as amyloidosis or sarcoidosis 11. any musculoskeletal or chronic condition that will interfere with completion of cardiac testing 12. active cancer 13. immunosuppressive therapy 14. baseline or pre-exercise echocardiogram demonstrates a reduced ejection fraction \</= 50% 15. currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy 16. Hypersensitivity to a SGLT2i 17. Pre-existing liver disease 18. ALT/AST\> 3x normal (ALT = alanine aminotransferase AST = aspartate aminotransferase) 19. history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months

Inclusion Criteria

Exclusion 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.

1. presence or history of diabetes
2. coronary revascularization within the last 6 months
3. hemodynamically significant valvular disease
4. significant lung disease requiring home oxygen
5. angina (chest pain)
6. non-revascularized myocardial ischemia
7. systolic BP \<100 or \>180 mmHg
8. pregnancy
9. clinical heart failure symptoms
10. history of systemic disease processes that can cause HFpEF such as amyloidosis or sarcoidosis
11. any musculoskeletal or chronic condition that will interfere with completion of cardiac testing
12. active cancer
13. immunosuppressive therapy
14. baseline or pre-exercise echocardiogram demonstrates a reduced ejection fraction \</= 50%
15. currently on sodium glucose cotransporter 2 inhibitor (SGLT2i) therapy
16. Hypersensitivity to a SGLT2i
17. Pre-existing liver disease
18. ALT/AST\> 3x normal (ALT = alanine aminotransferase AST = aspartate aminotransferase)
19. history of recurrent urinary tract infections (in the opinion of the investigator) or a urinary tract infection in the last 3 months

Contacts and Locations

Study Contact

Rupal Mehta, MD

CONTACT

(312) 503-1536

rupal.mehta@northwestern.edu

Tamara Isakova, MD

CONTACT

(312) 503-6921

tamara.isakova@northwestern.edu

Principal Investigator

Rupal Mehta, MD

PRINCIPAL_INVESTIGATOR

Northwestern Univeristy

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60607

United States

Collaborators and Investigators

Sponsor: Northwestern University

Rupal Mehta, MD, PRINCIPAL_INVESTIGATOR, Northwestern Univeristy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-16

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-01-16

Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

kidney
heart failure
kidney diseases

Additional Relevant MeSH Terms

Chronic Kidney Diseases
Heart Failure With Preserved Ejection Fraction
Kidney Diseases
Heart Failure