Pharmacokinetics of Bisoprolol and SGLT2i in Acutely Decompensated Heart Failure

Last updated: June 17, 2024
Sponsor: Universität des Saarlandes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Hyponatremia

Chest Pain

Treatment

Recompensation (guideline directed medical therapy)

Clinical Study ID

NCT06453577
BISO-ADHF
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients with decompensated heart failure caused by heart failure irrespective ofejection fraction (heart failure with reduced, mildly reduced or preserved ejectionfraction and de-novo heart failure)

  • Signs of decompensation: peripheral edema, jugular venous distension, pulmonaryrales, protodiastolic gallop rhythm, ascites, or demonstration of pulmonary venouscongestion 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

Exclusion Criteria:

  • Left ventricular or biventricular assist device therapy

  • Cardiogenic shock

  • need of vasopressor (catechoalmines) therapy or other inotropic support (dobutamineor 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

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Recompensation (guideline directed medical therapy)
Phase:
Study Start date:
May 01, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

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

    Homburg, 66421
    Germany

    Active - Recruiting

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