Actively Recruiting
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Led by University Medical Center Groningen · Updated on 2026-04-16
100
Participants Needed
2
Research Sites
94 weeks
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
B
Boehringer Ingelheim
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written and dated informed consent before joining the trial
- Age 18 years or older, any gender
- Have heart failure (any left ventricular ejection fraction) with eGFR between 25 and 90 mL/min/1.73m2 OR established cardiovascular disease with eGFR between 25 and 60 mL/min/1.73m2 OR cardiovascular disease with type 2 diabetes and eGFR between 25 and 90 mL/min/1.73m2
- Serum potassium level 5.0 mmol or less
- Currently treated with or eligible for treatment with empagliflozin
- Not used mineralocorticoid receptor antagonist or aldosterone synthase inhibitor in the last 6 months before enrollment
- On stable doses of other guideline-recommended medical therapies for at least 4 weeks before enrollment
- Outpatient status
You will not qualify if you...
- Unable to understand or sign informed consent
- Absolute contraindication to aldosterone antagonist
- Absolute contraindication to SGLT2 inhibitor
- Hospitalization for heart failure, acute coronary syndrome, cardiac surgery, stroke, or transient ischemic attack within 90 days before enrollment
- Women who are pregnant, breastfeeding, or may become pregnant during the study
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Delphinium
Groningen, Provincie Groningen, Netherlands, 9713GZ
Actively Recruiting
2
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9713GZ
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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