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.

NCT Number	NCT06453577
Lead Sponsor	Universität des Saarlandes
Conditions	Acute Decompensated Heart Failure
Enrollment	33 participants
Start Date	2023-05-01
Primary Completion	2024-05-01 (estimated)
Study Completion	2026-07-08 (estimated)
Updated on ClinicalTrials.gov	2026-07-23