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

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What is this study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Delphinium B.V.	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	20.03.2026

Trial locations

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.

Investigated diseases:

Chronic kidney disease

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 ID:

2025-523743-35-00

Protocol code:

COMPARE-VS

NCT ID:

NCT07304817

Trial Phase:

Therapeutic exploratory (Phase II)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?