Actively Recruiting
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects in Patients With Chronic Kidney Disease and Cardiovascular Disease or Heart Failure
Led by University Medical Center Groningen · Updated on 2026-05-29
100
Participants Needed
2
Research Sites
N/A
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
Researchers are investigating the effects of two different drug combinations on kidney function and protein profiles in blood and urine in patients with chronic kidney disease (CKD) who also have cardiovascular disease or heart failure. The study compares vicadrostat, an aldosterone synthase inhibitor, combined with empagliflozin, against spironolactone, a mineralocorticoid receptor antagonist, combined with empagliflozin. The goal is to understand how these drugs differ in their impact on kidney and heart function due to their different mechanisms of action. Participants will be randomly assigned to one of two groups. Group 1 will take one tablet of vicadrostat (10 mg) and one tablet of empagliflozin (10 mg) daily for 26 weeks. Group 2 will take one tablet of spironolactone (25 mg) and one tablet of empagliflozin (10 mg) daily for the first four weeks, then two tablets of spironolactone (50 mg) and one tablet of empagliflozin (10 mg) daily for the remaining 22 weeks, with possible dose adjustments based on blood tests. The study is open-label with blinded endpoint assessment. During the study, kidney function will be measured at the start, at 4 weeks, and at 26 weeks. In about half of participants, detailed kidney blood flow measurements will also be taken at these times. Researchers will also examine changes in protein profiles and concentration markers in blood and urine. The study will monitor treatment effects and safety over the 26-week period, with patient visits and assessments scheduled accordingly.
CONDITIONS
Brief 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 study
- Age 18 years or older, male or female
- Diagnosed with heart failure (any LVEF) and eGFR between 25-90 mL/min/1.73m2 OR
- Diagnosed with established cardiovascular disease and eGFR between 25-60 mL/min/1.73m2 OR
- Diagnosed with cardiovascular disease and type 2 diabetes with eGFR between 25-90 mL/min/1.73m2
- Serum potassium level of 5.0 mmol/L or lower
- Currently treated with or eligible for treatment with empagliflozin
- No use of mineralocorticoid receptor antagonist or aldosterone synthase inhibitor in the last 6 months
- On stable doses of other guideline-directed 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 for aldosterone antagonist
- Absolute contraindication for 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 period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive daily treatment with either Vicadrostat or Spironolactone alongside background Empagliflozin for 26 weeks.
Visits at baseline, Week 4, and Week 26
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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