Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
EU CTIS ID: 2025-523743-35-00
What this study is testing
The main objective of this study in patients with heart failure (HF) or cardiovascular disease (CVD) and chronic kidney disease (CKD) is to compare the effects of the ASi, vicadrostat, with the steroidal MRA, spironolactone, on the change in kidney function from baseline to 4 and 26 weeks.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 background treatment with Empagliflozin*4
- Not using a MRA or AS inhibitor in the last 6 months prior to enrollment
You likely can't join if
- Inability to understand and sign informed consent
- Absolute contra-indication for aldosterone antagonist
- 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
- Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.
See the full eligibility criteria
- 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 background 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
- Inability to understand and sign informed consent
- Absolute contra-indication for aldosterone antagonist
- 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
- Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.