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New drug combo aims to protect kidneys in heart patients

NCT ID NCT07304817

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two different drugs, vicadrostat and spironolactone, both taken with empagliflozin, to see how they affect kidney function and protein levels in blood and urine. The trial involves 100 adults with chronic kidney disease and heart disease or heart failure. Participants will take one of the two drug combinations daily for 26 weeks to understand which approach works better for kidney protection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Provided written and dated informed consent for participation prior to trial admission, 2. Age ≥18 years, female or male 3. 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 4. Serum potassium ≤ 5.0 mmol 5. Currently treated or eligible for treatment with Empagliflozin\*4 6. Not using a MRA or AS inhibitor in the last 6 months prior to enrollment 7. On stable doses of other guideline directed medical therapies for ≥ 4 weeks prior to enroll-ment 8. Outpatient. * 1 HF is defined as the definition used in the most recent ESC guidelines for HF. * 2 eGFR as assessed by the 2009 CKD-EPI without the race coefficient * 3 Cardiovascular disease is defined as a history of a myocardial infarction, coronary bypass surgery, PCI, or proven coronary artery disease (e.g. by coronary angiography, CT-scan, etc.) * 4 If switching from another SGLT2i to Empagliflozin subjects can be enrolled directly. If the subject is not yet on SGLT2i and starts Empagliflozin enrollment can start 4 weeks later see criteria 8. Exclusion Criteria: 1. Inability to understand and sign informed consent 2. Absolute contra-indication for aldosterone antagonist 3. Absolute contra-indication for a SGLT2-inhibitor 4. Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment 5. Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Delphinium

    RECRUITING

    Groningen, Provincie Groningen, 9713GZ, Netherlands

  • University Medical Center Groningen

    RECRUITING

    Groningen, Provincie Groningen, 9713GZ, Netherlands

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