NCT06453577Completed
Pharmacokinetics of Bisoprolol and SGLT2i in Acutely Decompensated Heart Failure
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)
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 33 (actual)
- First submitted
- 29 May 2024
- Start date
- 1 May 2023
- Primary completion date
- 1 May 2024
- Lead sponsor
- Universität des Saarlandes
- Diseases
- Heart failure
- NCT number
- NCT06453577
What you commit to
- Study type: Observational
- Participants enrolled: 33
- From 1 May 2023 to the primary completion date, 1 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Left ventricular or biventricular assist device therapy
- need of vasopressor (catechoalmines) therapy or other inotropic support (dobutamine or levosimendan)
Other illness
- Inflammatory bowel disease (eg, M. Crohn or Colitis ulcerosa)
Other
- Cardiogenic shock
- Clinical symptomatic hypotension
- Bradycardia (\<50 bpm)
- patients requiring dialysis (CVVHD)
- Not able to give written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University Coordinator of this site? Confirm its status | Homburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.