Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease (NCT05719714) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Effect of Dapagliflozin on Metabolomics and Cardiac Mechanics in Chronic Kidney Disease
United States18 participantsStarted 2024-01-16
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically looking at people with both chronic kidney disease and heart failure with preserved ejection fraction — does my diagnosis actually match both of those conditions, and would that affect whether my doctor thinks this study is relevant to my situation?
2Since this is a Phase 1/2 trial studying dapagliflozin's effects on heart mechanics and metabolic markers, what does that phase mean for how much is already known about the safety and benefit of this drug for someone with my combination of kidney disease and heart failure?
3The trial is measuring something called left ventricular longitudinal strain and peak oxygen consumption — can my doctor explain what those measurements tell us about my heart function, and whether those are areas of concern in my own case?
4The trial is no longer actively recruiting, so I can't join — but given that it's studying dapagliflozin for CKD and heart failure with preserved ejection fraction, is dapagliflozin something my doctor would consider prescribing for me outside of a trial, based on existing evidence?
5Since this trial is tracking circulating plasma metabolites, is there anything about my current kidney function or medications that my doctor thinks could make dapagliflozin a risky or potentially beneficial option for me to explore through other means?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.