Clinical trial • Phase IV • Cardiology|Nephrology

BI 690517 for Heart failure|Cardiovascular disease|Chronic kidney disease|Type 2 diabetes

Phase IV trial of BI 690517 for Heart failure|Cardiovascular disease|Chronic kidney disease|Type 2 diabetes.

Overview

Trial Therapeutic Area: Cardiology|Nephrology
Trial Disease: Heart failure|Cardiovascular disease|Chronic kidney disease|Type 2 diabetes
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 23-01-2026
First CTIS Authorization Date: 23-03-2026

Trial design

Randomised, open-label, arms: spironolactone + empagliflozin (spironolacton accord 25 mg filmomhulde tabletten; product max daily dose: 50 mg; empagliflozin (jardiance 10 mg film-coated tablets; max daily dose: 10 mg)) and vicadrostat + empagliflozin (vicadrostat = bi 690517; sponsor product code bi 690517; max daily dose recorded 10 mg; empagliflozin (jardiance 10 mg)). schedule not specified in part i data.-controlled Phase IV trial across 1 site in Netherlands.

Randomised: Yes
Open Label: Yes
Comparator: Arms: Spironolactone + Empagliflozin (Spironolacton Accord 25 mg filmomhulde tabletten; product max daily dose: 50 mg; Empagliflozin (Jardiance 10 mg film-coated tablets; max daily dose: 10 mg)) and Vicadrostat + Empagliflozin (Vicadrostat = BI 690517; sponsor product code BI 690517; max daily dose recorded 10 mg; Empagliflozin (Jardiance 10 mg)). Schedule not specified in Part I data.
Target Sample Size: 100
Trial Duration For Participant: 182

Eligibility

Recruits 100 Vulnerable population not selected. Participants must provide written and dated informed consent for participation prior to trial admission; "Inability to understand and sign informed consent" is listed as an exclusion. Trial population restricted to adults (Age ≥18 years)..

Pregnancy Exclusion: Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.
Vulnerable Population: Vulnerable population not selected. Participants must provide written and dated informed consent for participation prior to trial admission; "Inability to understand and sign informed consent" is listed as an exclusion. Trial population restricted to adults (Age ≥18 years).

Inclusion criteria

{"criterion_text":"- Provided written and dated informed consent for participation prior to trial admission,\n- Age ≥18 years, female or male\n- Patients with •\tHeart failure*1 (any LVEF) and eGFR*2 between 25-90 mL/min/1.73m2 OR •\tEstablished cardiovascular disease*3 and eGFR between 25-60 mL/min/1.73m2 OR •\tEstablished cardiovascular disease and type 2 diabetes and eGFR between 25-90 mL/min/1.73m2\n- Serum potassium ≤ 5.0 mmol\n- Currently treated or eligible for background treatment with Empagliflozin*4\n- Not using a MRA or AS inhibitor in the last 6 months prior to enrollment\n- On stable doses of other guideline directed medical therapies for ≥ 4 weeks prior to enroll-ment\n- Outpatient"}

Exclusion criteria

{"criterion_text":"- Inability to understand and sign informed consent\n- Absolute contra-indication for aldosterone antagonist\n- Absolute contra-indication for a SGLT2-inhibitor\n- Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment\n- Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration."}

Endpoints

Primary endpoints

{"endpoint_text":"- The primary endpoint for kidney function is the change in eGFR baseline to 4 and 26 weeks of treatment","definition_or_measurement_approach":"Change in eGFR from baseline to 4 and 26 weeks; eGFR assessed as estimated glomerular filtration rate (eGFR)."}

Secondary endpoints

{"endpoint_text":"- 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","definition_or_measurement_approach":"Measured glomerular filtration rate (mGFR), ERPF, RBF, RVR, Pglo, Ra, Re measured at baseline and after 4 and 26 weeks."}
{"endpoint_text":"- 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","definition_or_measurement_approach":"Comparison of changes in plasma and urinary protein profiles between vicadrostat (BI 690517) and spironolactone at 4 and 26 weeks."}
{"endpoint_text":"- Changes in UACR and urinary concentration of sodium, NGAL, and KIM-1 from baseline to 4 and 26 weeks","definition_or_measurement_approach":"Change from baseline in urinary albumin-to-creatinine ratio (UACR) and urinary concentrations of sodium, NGAL and KIM-1 at 4 and 26 weeks."}

Recruitment

Planned Sample Size: 100
Recruitment Window Months: 25
Consent Approach: Written and dated informed consent required from each participant prior to trial admission. Participants must be ≥18 years. Subject information and informed consent form documents are listed (L1_SIS and ICF adults). Languages not specified. Inability to understand and sign informed consent is an exclusion.

Geography

Total Number Of Sites: 1
Total Number Of Participants: 100

Netherlands

Earliest CTIS Part Ii Submission Date: 12-03-2026
Latest Decision Or Authorization Date: 23-03-2026
Processing Time Days: 11
Number Of Sites: 1
Number Of Participants: 100

Sites

Site Name: Delphinium B.V.
Department Name: -
Contact Person Name: David Smeijer
Contact Person Email: info@delphiniumcro.com

Sponsor

Primary sponsor

Full Name: Universitair Medisch Centrum Groningen
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Netherlands

Contract research organisations

Name: Delphinium B.V.
Responsibilities: Listed as trial site and provided contact for trial operations (site contact and operational coordination).

Third parties

{"country":"","full_name":"Boehringer Ingelheim International GmbH","duties_or_roles":"Monetary support","organisation_type":""}

Investigational products

Investigational Product Name: BI 690517
Active Substance: BI 690517
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Not authorised / Investigational
Maximum Dose: 10 mg (maxDailyDoseAmount 10 mg)

Investigational Product Name: Spironolacton Accord 25 mg filmomhulde tabletten
Active Substance: Spironolactone
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised (marketing authorisation RVG 24025)
Maximum Dose: 50 mg (maxDailyDoseAmount 50 mg)

Investigational Product Name: Jardiance 10 mg film-coated tablets
Active Substance: Empagliflozin
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Authorised (marketing authorisation EU/1/14/930/018)
Maximum Dose: 10 mg (maxDailyDoseAmount 10 mg)

Investigational Product Name: OMNIPAQUE 350 mg I/ml.
Active Substance: Iohexol
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Authorisation Status: Authorised (marketing authorisation RVG 09821)
Maximum Dose: 36 mg/kg (maxDailyDoseAmount 36 mg/kg)

Investigational Product Name: AMINOHIPPURIC ACID
Active Substance: Aminohippuric acid
Modality: Small molecule
Routes Of Administration: INFUSION
Route: INFUSION
Maximum Dose: 6 mg/kg (maxDailyDoseAmount 6 mg/kg)

Combination Treatment: Yes

Related trials

Other published trials that may interest you.