Vicadrostat or spironolactone with empagliflozin in kidney disease with heart problems
Compares two drug combinations in adults with chronic kidney disease and heart disease.
Plain-language title generated from the registry record
Registry title: Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Key facts
- Where
- Groningen, NetherlandsSee the site
- Phase
- Phase 2
Where in Netherlands
- Delphinium B.V.Groningen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Medical Center Groningen
- Trial code
- NCT07304817EU 2025-523743-35-00
- Record updated
- 29 May 2026
- Original description
In this study, investigators will compare the effect of vicadrostat combined with empagliflozin with the effect of spironolactone combined with empagliflozin on renal function and changes in protein profiles in blood and urine.Read full original descriptionShow less
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects in Patients Chronic Kidney Disease With Cardiovascular Disease /Heart Failure
In this study, investigators will compare the effect of vicadrostat combined with empagliflozin with the effect of spironolactone combined with empagliflozin on renal function and changes in protein profiles in blood and urine.
The hypothesis is that the renal and cardiac responses between vicadrostat and spironolactone differ due to mechanistic differences in their mode of action. Spironolactone is a mineralocorticoid receptor antagonist (MRA) and exerts its effect on a receptor, or a type of "receiver," found on various cells. Vicadrostat is an aldosterone synthase inhibitor (ASI) and inhibits aldosterone production. Therefore, both drugs affect aldosterone.
However, studies evaluating the differences between MRAs (such as spironolactone) and ASI (such as vicadrostat) and examining their effects on the kidneys in patients with chronic kidney disease with concurrent cardiovascular disease, and/or heart failure are still lacking.
For this study, all participants will be divided into two groups:
* Group 1. Participants in this group will receive one tablet of vicadrostat (10 mg) and one tablet of empagliflozin (10 mg) daily for 26 weeks. * Group 2. Participants in this group will receive one tablet of spironolactone (25 mg) and one tablet of empagliflozin (10 mg) daily for the first four weeks. Participants in this group will then receive two tablets of spironolactone (50 mg) and one tablet of empagliflozin (10 mg) daily for the remaining 22 weeks. The spironolactone dosage may be adjusted during the study period (from 12.5 to 50 mg) based on blood test results.
Inclusion: Provided written and dated informed consent for participation prior to trial admission,; Age ≥18 years, female or male; 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; Serum potassium ≤ 5.0 mmol; Currently treated or eligible for treatment with Empagliflozin*4; Not using a MRA or AS inhibitor in the last 6 months prior to enrollment; On stable doses of other guideline directed medical therapies for ≥ 4 weeks prior to enroll-ment; 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: Absolute contra-indication for a SGLT2-inhibitor; Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment; Inability to understand and sign informed consent; Absolute contra-indication for aldosterone antagonist; Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.