NCT07304817RecruitingPhase 2
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 20 Nov 2025
- Start date
- 12 May 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Chronic kidney disease, Heart failure
- NCT number
- NCT07304817
- EU CT number
- 2025-523743-35-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 12 May 2026 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Delphinium B.V. Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.