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Can common heart drugs stay safe during a crisis? a trial investigates

NCT ID NCT06453577

Disease control Sponsor: Universität des Saarlandes Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial examines how two standard heart failure medications—bisoprolol (a beta blocker) and SGLT2 inhibitors (dapagliflozin or empagliflozin)—are processed by the body during an acute decompensated heart failure episode. Researchers will measure drug levels and heart function in 33 participants both during the acute phase and after stabilization. The goal is to provide evidence-based dosing recommendations for these drugs in a critical care setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bisoprolol and SGLT2 inhibitors (dapagliflozin or empagliflozin)
What this could lead to
If successful, this could provide clear dosing guidance for continuing bisoprolol and SGLT2 inhibitors during acute heart failure episodes, potentially improving safety and outcomes.
What could go wrong
This is a small, early-phase study (33 participants) focused on drug levels and short-term effects, not long-term outcomes. Results may not apply to all heart failure patients.

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.

Participants

33 people

The number who actually took part.

Started

May 2023

Finished

Jul 2026

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.

Who is studied

Patients presenting with acute decompensated heart failure (ADHF) at the intensive care unit at Saarland University Medical Center

Ages

18 years and older

Sex

Anyone

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: * Patients with decompensated heart failure caused by heart failure irrespective of ejection fraction (heart failure with reduced, mildly reduced or preserved ejection fraction and de-novo heart failure) * Signs of decompensation: peripheral edema, jugular venous distension, pulmonary rales, protodiastolic gallop rhythm, ascites, or demonstration of pulmonary venous congestion on chest X-ray * Previous documented beta blocker therapy * elevated natriuretic peptides (nt-pro-BNP ≥125 pg/ml) * patients admitted to the intensive care unit Exclusion Criteria: * Left ventricular or biventricular assist device therapy * Cardiogenic shock * need of vasopressor (catechoalmines) therapy or other inotropic support (dobutamine or levosimendan) * Clinical symptomatic hypotension * Bradycardia (\<50 bpm) * patients requiring dialysis (CVVHD) * Inflammatory bowel disease (eg, M. Crohn or Colitis ulcerosa) * Not able to give written informed consent

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

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

Acute decompensated heart failure

Contacts and locations

Locations

  • Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University

    Homburg, 66421, Germany

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