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A study to compare the effects of BI 690517 and spironolactone on kidney function in patients with heart failure, cardiovascular disease, or chronic kidney disease

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is designed to compare how two different medications affect kidney function in people living with Heart Failure, Cardiovascular Disease, or Chronic Kidney Disease. The medications being studied are BI 690517 and Spironolactone. Additionally, some participants may be taking Empagliflozin as part of their ongoing care.

The purpose of the study is to compare the effects of BI 690517 to Spironolactone on kidney function and how blood flows through the kidneys. Researchers will look at Renal Hemodynamics, which refers to how blood moves through the kidney organs, and changes in protein levels in the blood and urine. The study will monitor how these treatments impact Glomerular Filtration Rate, a measurement used to check how well the kidneys filter waste from the blood, over a period of time.

During the study, participants will be observed at different intervals, specifically at 4 weeks and 26 weeks, to track changes in their kidney health and blood flow. Other substances such as Iohexol or Aminohippuric Acid may be used during certain procedures to help measure kidney performance.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of the trial and baseline assessment

    At the start of the trial, baseline measurements are taken to establish initial kidney function and protein levels.

    Initial tests are conducted to measure the estimated glomerular filtration rate (eGFR), which is a way to check how well the kidneys are filtering blood.

    Assessments of renal hemodynamics, which refers to the blood flow and pressure within the kidneys, are performed.

    Measurements of plasma and urinary protein profiles are taken to understand current protein levels in the blood and urine.

  2. Step 2

    Medication administration and treatment period

    One of two different medications will be administered orally for a period of 26 weeks.

    The first option is vicadrostat (BI 690517), which is taken as a 10 mg film-coated tablet.

    The second option is spironolactone, which is taken as a 50 mg film-coated tablet.

    As part of the background treatment, jardiance (empagliflozin) is taken as a 10 mg film-coated tablet.

  3. Step 3

    Follow-up assessments at week 4

    After 4 weeks of treatment, kidney function is reassessed by measuring the eGFR.

    Changes in renal hemodynamics, including blood flow and vascular resistance in the kidneys, are measured.

    Levels of urinary proteins, such as uacr (urine albumin-to-creatinine ratio), sodium, ngal, and kim-1, are evaluated.

  4. Step 4

    Final assessments at week 26

    After 26 weeks of treatment, a final assessment of kidney function is conducted using the eGFR.

    The final measurements of renal hemodynamics, including blood flow and pressure within the kidney vessels, are recorded.

    Changes in plasma and urinary protein profiles are compared to the baseline measurements to determine the effect of the medication.

Who can join the trial?

10 criteria

  • You must be 18 years of age or older and can be either male or female.
  • You must give your written and dated consent, which means you formally agree to take part in the study after being told all the details.
  • You must have heart failure, which is a condition where the heart cannot pump blood as well as it should, and a specific range for your eGFR, which is a measure used to check how well your kidneys are filtering your blood.
  • Alternatively, you may qualify if you have established cardiovascular disease, which refers to long-term diseases of the heart and blood vessels, along with certain kidney function levels.
  • You may also qualify if you have both cardiovascular disease and type 2 diabetes, along with specific kidney function levels.
  • Your serum potassium, which is the level of a mineral called potassium found in your blood, must be 5.0 mmol or less.
  • You must be currently taking or be able to take Empagliflozin, which is a type of medication used to help treat certain heart and kidney conditions.
  • You must not have used an MRA (a type of medicine that affects hormones to manage blood pressure) or an AS inhibitor (a medicine that blocks certain natural substances in the body) in the 6 months before joining the study.
  • You must have been taking stable doses of other recommended medical treatments for at least 4 weeks before starting the study.
  • You must be an outpatient, which means you receive medical treatment without staying overnight in a hospital.

Who cannot join the trial?

5 criteria

  • You are unable to understand or sign the informed consent, which is a document that explains all the details of the study before you agree to join.
  • You have a medical reason why you cannot take aldosterone antagonists, which are a type of medicine used to manage certain hormone levels in the body.
  • You have a medical reason why you cannot take SGLT2-inhibitors, which are a specific class of medication used to help control blood sugar or protect the kidneys.
  • You were hospitalized for heart failure (a condition where the heart cannot pump blood well enough), experienced acute coronary syndrome (a sudden reduction of blood flow to the heart), had cardiac surgery, or had a stroke or transient ischemic attack (a temporary period of symptoms similar to a stroke) within the last 90 days.
  • You are pregnant, breastfeeding, or planning to become pregnant during the time you are in the study.
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Investigated drugs

  • BI 690517

    is an experimental medication being tested to see how it affects kidney function in patients with heart failure or cardiovascular disease along with chronic kidney disease.

  • Spironolactone

    is a medication used as a comparison to see how it affects kidney function and protein profiles compared to the experimental drug.

What is already known about the treatment

  • Empagliflozin

    This medication is taken orally in the form of a film-coated tablet and is widely used in clinical practice to manage type 2 diabetes and protect heart and kidney health. It belongs to a class of drugs called SGLT2 inhibitors, which work by preventing the kidneys from reabsorbing sugar back into the blood, allowing the extra glucose to be removed through urine. By lowering blood sugar and reducing pressure in the kidneys, it helps manage cardiovascular and renal conditions.

  • BI 690517

    This substance is an experimental medication administered orally as a film-coated tablet and is currently being studied in clinical trials rather than being available for general medical use. It is classified as an aldosterone synthase inhibitor, a type of drug designed to block the production of a hormone called aldosterone. By reducing the levels of this hormone at the molecular level, it aims to treat conditions related to heart failure and kidney disease.

  • Spironolactone

    This is an established medication taken orally as a film-coated tablet used to treat high blood pressure, heart failure, and swelling caused by fluid buildup. It is classified as a mineralocorticoid receptor antagonist, which means it works by blocking the effects of the hormone aldosterone on the body's cells. This action helps the kidneys release more sodium and water, which lowers blood pressure and reduces the workload on the heart.

  • Iohexol

    This substance is administered through an infusion as a solution for injection and is commonly used in medical imaging to help visualize internal organs. It is classified as a radiocontrast medium, which works by absorbing X-rays to create clear images during procedures like CT scans. While it is a standard tool in diagnostic medicine, it is used to assist in imaging rather than as a treatment for a specific disease.

  • Aminohippuric acid

    This substance is administered via infusion and is used in specialized medical research settings to study how well the kidneys are functioning. It is classified as a diagnostic agent that works by being filtered out of the blood by the kidneys and excreted in urine. By measuring how quickly the body processes this substance, doctors can assess the filtration rate and overall health of the renal system.

Investigated diseases

  • Heart failure

    This condition occurs when the heart muscle is unable to pump blood effectively to meet the body's needs. It often develops gradually as the heart becomes weakened or stiff over time. As the disease progresses, the heart may struggle to circulate enough oxygen-rich blood to various organs. This can lead to a buildup of fluid in the lungs or other parts of the body.

  • Cardiovascular disease

    This term refers to a group of disorders that affect the heart and blood vessels. It typically involves the narrowing or hardening of the arteries, which can restrict blood flow throughout the body. The condition can progress through various stages, potentially affecting how well the heart functions or how blood moves through the vascular system.

  • Chronic kidney disease

    This is a long-term condition where the kidneys gradually lose their ability to filter waste products from the blood. Over time, the filtering units within the kidneys become damaged and less efficient. As the disease advances, the kidneys may fail to maintain the body's chemical balance or remove excess fluids properly.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523743-35-00Protocol codeCOMPARE-VSEstimated enrolment100 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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