New drug combo aims to protect kidneys in heart patients
NCT ID NCT07304817
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two different drugs, vicadrostat and spironolactone, both taken with empagliflozin, to see how they affect kidney function and protein levels in blood and urine. The trial involves 100 adults with chronic kidney disease and heart disease or heart failure. Participants will take one of the two drug combinations daily for 26 weeks to understand which approach works better for kidney protection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Provided written and dated informed consent for participation prior to trial admission, 2. Age ≥18 years, female or male 3. Patients with * Heart failure\*1 (any LVEF) and eGFR\*2 between 25-90 mL/min/1.73m2 OR * Established cardiovascular disease\*3 and eGFR between 25-60 mL/min/1.73m2 OR * Established cardiovascular disease and type 2 diabetes and eGFR between 25-90 mL/min/1.73m2 4. Serum potassium ≤ 5.0 mmol 5. Currently treated or eligible for treatment with Empagliflozin\*4 6. Not using a MRA or AS inhibitor in the last 6 months prior to enrollment 7. On stable doses of other guideline directed medical therapies for ≥ 4 weeks prior to enroll-ment 8. Outpatient. * 1 HF is defined as the definition used in the most recent ESC guidelines for HF. * 2 eGFR as assessed by the 2009 CKD-EPI without the race coefficient * 3 Cardiovascular disease is defined as a history of a myocardial infarction, coronary bypass surgery, PCI, or proven coronary artery disease (e.g. by coronary angiography, CT-scan, etc.) * 4 If switching from another SGLT2i to Empagliflozin subjects can be enrolled directly. If the subject is not yet on SGLT2i and starts Empagliflozin enrollment can start 4 weeks later see criteria 8. Exclusion Criteria: 1. Inability to understand and sign informed consent 2. Absolute contra-indication for aldosterone antagonist 3. Absolute contra-indication for a SGLT2-inhibitor 4. Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment 5. Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Delphinium
RECRUITINGGroningen, Provincie Groningen, 9713GZ, Netherlands
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University Medical Center Groningen
RECRUITINGGroningen, Provincie Groningen, 9713GZ, Netherlands
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