Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 85Years
All Genders
ID05719714

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

Led by Northwestern University · Updated on 2026-04-13

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of dapagliflozin, a sodium-glucose transport protein 2 inhibitor, on heart and lung function and blood metabolites in patients with chronic kidney disease (CKD) who also have signs of subclinical heart failure with preserved ejection fraction (HFpEF). This research aims to understand how adding dapagliflozin to standard care influences cardiac mechanics and circulating metabolites over six months. The study is an interventional trial involving sixty CKD patients with specific heart function criteria or exercise capacity limits. Participants are randomly assigned to one of two groups: thirty will take dapagliflozin 10 mg daily for six months alongside their standard treatment, while thirty will continue with standard care only. The study measures changes in heart muscle strain and lung oxygen consumption, as well as metabolite levels in the blood, to see if dapagliflozin causes beneficial metabolomic changes associated with improved heart and exercise function. During the study, participants undergo metabolomic testing, 2D-speckle tracking echocardiography, and cardiopulmonary exercise testing at the start and after six months. The primary outcomes include left ventricular longitudinal strain, peak oxygen consumption, and plasma metabolite concentrations. Secondary outcomes involve left atrial reservoir strain and right ventricular wall strain. The trial monitors participants' heart and lung function carefully throughout the six-month period to assess the effects of the study drug compared to standard care.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years of age
  • Estimated glomerular filtration rate (eGFR) between 25 and 60 ml/min/1.73m2
  • On stable doses of diuretics and/or angiotensin converting enzyme inhibitors or angiotensin receptor blockers
  • Evidence of subclinical heart failure with preserved ejection fraction based on specific echocardiography criteria or exercise testing results
Not Eligible

You will not qualify if you...

  • 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 blood pressure less than 100 or greater than 180 mmHg
  • Pregnancy
  • Clinical heart failure symptoms
  • History of systemic diseases causing heart failure with preserved ejection fraction such as amyloidosis or sarcoidosis
  • Any musculoskeletal or chronic condition interfering with cardiac testing
  • Active cancer
  • Immunosuppressive therapy
  • Reduced ejection fraction less than 50% on echocardiogram
  • Current use of sodium glucose cotransporter 2 inhibitor therapy
  • Hypersensitivity to sodium glucose cotransporter 2 inhibitors
  • Pre-existing liver disease
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than three times normal
  • History of recurrent urinary tract infections or urinary tract infection within the last 3 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 6 months

Participants receive dapagliflozin 10mg daily or standard of care for six months to evaluate effects on metabolomics and cardiac function.

Baseline and 6-month visits for metabolomic and cardiac testing

Trial Site Locations

Total: 1 location

1

Northwestern University

Chicago, Illinois, United States, 60607

Actively Recruiting

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Research Team

R

Rupal Mehta, MD

T

Tamara Isakova, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association.

Paul A Heidenreich, Justin G Trogdon, Olga A Khavjou...

https://pubmed.ncbi.nlm.nih.gov/21262990

Worsening of renal function during 1 year after hospital discharge is a strong and independent predictor of all-cause mortality in acute decompensated heart failure.

Tomoya Ueda, Rika Kawakami, Yu Sugawara...

https://pubmed.ncbi.nlm.nih.gov/25370599

The prognostic implications of renal insufficiency in asymptomatic and symptomatic patients with left ventricular systolic dysfunction.

D L Dries, D V Exner, M J Domanski...

https://pubmed.ncbi.nlm.nih.gov/10716471