Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects in Patients with Heart Failure or Cardiovascular Disease and Chronic Kidney Disease (COMPARE-VS)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523743-35-00

Enrollment

100

Registered

2026-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure, cardiovascular disease, chronic kidney disease

Brief summary

The primary endpoint for kidney function is the change in eGFR baseline to 4 and 26 weeks of treatment

Detailed description

The endpoints for the renal hemodynamic changes includes measured glomerular filtration rate (mGFR), effective renal plasma flow (ERPF), renal blood flow (RBF), renal vascular resistance (RVR), glomerular pressure (Pglo), afferent vascular resistance (Ra) and efferent vascular resistance (Re) at baseline and after 4 and 26 weeks of treatment, Endpoints related to plasma and urinary protein profiles are the difference in changes in their profiles between vicadrostat and spironolactone after 4 and 26 weeks of treatment, Changes in UACR and urinary concentration of sodium, NGAL, and KIM-1 from baseline to 4 and 26 weeks

Interventions

DRUGJardiance 10 mg film-coated tablets

DRUGBI 690517

DRUGSpironolacton Accord 25 mg filmomhulde tabletten

DRUGOMNIPAQUE 350 mg I/ml.

DRUGAMINOHIPPURIC ACID

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint for kidney function is the change in eGFR baseline to 4 and 26 weeks of treatment	—

Secondary

Measure	Time frame
The endpoints for the renal hemodynamic changes includes measured glomerular filtration rate (mGFR), effective renal plasma flow (ERPF), renal blood flow (RBF), renal vascular resistance (RVR), glomerular pressure (Pglo), afferent vascular resistance (Ra) and efferent vascular resistance (Re) at baseline and after 4 and 26 weeks of treatment, Endpoints related to plasma and urinary protein profiles are the difference in changes in their profiles between vicadrostat and spironolactone after 4 and 26 weeks of treatment, Changes in UACR and urinary concentration of sodium, NGAL, and KIM-1 from baseline to 4 and 26 weeks	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 24, 2026