NCT07304817 Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 100 participants in total. It began in 2026-05-12 with a primary completion date of 2028-02.

Brief Summary

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.

Eligibility Criteria

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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