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Completed

NCT Number: NCT06453577

Pharmacokinetics of Bisoprolol and SGLT2i in Acutely Decompensated Heart Failure

The pharmacokinetics (PK) and pharmacodynamics (PD) of bisoprolol and sodium-glucose co-transporter-2 inhibitors (SGLT2i, dapagliflozin and empagliflozin) in patients with acutely decompensated heart failure (ADHF), compared to the recompensated state, is unknown. If not in cardiogenic shock (no need of vasopressor (catechoalmines) therapy or other inotropic support), established oral betablocker therapy should de continued. Whether this holds true for SGLT2i in ADHF is less clear but current evidence suggest safety and potentially beneficial effects in doing so.

To the best of our knowledge, no data regarding PK/PD are available for the most widely used beta blocker bisoprolol and the newly approved/in Germany available SGLT2i Dapagliflozin and Empagliflozin. This study shall provide first evidence on the PK/PD-profile of p.o. bisoprolol and SGLT2i (dapaglifozin or empagliflozin) regarding acute (hemodynamic) effects and safety as well as to provide data on dose recommendations eventually in patients with ADHF.

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Key information

Conditions

Acute Decompensated Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Homburg, 66421, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recompensation (guideline directed medical therapy)

Drug

Recompensation mainly achieved by intravenous diuretics and/or vasodilators but no requirement for positive inotropic drugs such as catecholamines or levosimendan.

Primary outcomes

  1. Maximum Plasma Concentration [Cmax in ng/ml] of Bisoprolol/ Dapagliflozin/ Empaglifozin

    Time frame: up to 7 days

    toxicological measurements (using liquid chromatography coupled to high-resolution mass spectrometry) of drug levels in venous blood in decompensated and recompensated state (Comparison decompensated and recompensated state)

  2. Plasma Concentration (in ng/ml) over time of Bisoprolol/ Dapaglifozin/ Empagliflozin (AUC= Area under the curve)

    Time frame: up to 7 days

    toxicological measurements (using liquid chromatography coupled to high-resolution mass spectrometry) of drug levels in venous blood in decompensated and recompensated state (Comparison decompensated and recompensated state)

Secondary outcomes

  1. Hemodynamic assessment (blood pressure in mmHg) of patients in decompensated and recompensated state

    Time frame: up to 7 days

    Pharmacodynamics of Bisoprolol and Dapagliflozin and Empagliflozin

  2. Hemodynamic assessment (heart rate in bpm) of patients in decompensated and recompensated state

    Time frame: up to 7 days

    Pharmacodynamics of Bisoprolol and Dapagliflozin and Empagliflozin

Sponsors and collaborators

Lead sponsor

Universität des Saarlandes

Other

Registry information

Official study title

Pharmacokinetics and Pharmacodynamics of Bisoprolol and SGLT2-Inhibitors (Dapagliflozin, Empagliflozin) in Acutely Decompensated Heart Failure BISO-ADHF (BI=BIsoprolol, SO=Sodium-glucose Co-transporter-2 Inhibitors in Acute Decompensated Heart Failure)

Acronym: BISO-ADHF

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Jun 11, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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