Clinical trial NCT06453577: Pharmacokinetics of Bisoprolol and SGLT2i in Acutely Decompensated Heart Failure
Official 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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Decompensated Heart Failure
Keywords: Acute Decompensated Heart Failure
Bisoprolol
SGLT2-inhibitors
Pharmacokinetics
Pharmacodynamics
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with acute decompensated heart failure (ADHF) at the intensive care unit at Saarland University Medical Center

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Plasma Concentration [Cmax in ng/ml] of Bisoprolol/ Dapagliflozin/ Empaglifozin
timeFrame: up to 7 days
measure: Plasma Concentration (in ng/ml) over time of Bisoprolol/ Dapaglifozin/ Empagliflozin (AUC= Area under the curve)
timeFrame: up to 7 days
Secondary outcomes:
measure: Hemodynamic assessment (blood pressure in mmHg) of patients in decompensated and recompensated state
timeFrame: up to 7 days
measure: Hemodynamic assessment (heart rate in bpm) of patients in decompensated and recompensated state
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University
Study officials:
References: