Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07304817

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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