Pharmacokinetics of Bisoprolol and SGLT2i in Acutely Decompensated Heart Failure

NCT ID: NCT06453577

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-12-31

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.

Conditions

Acute Decompensated Heart Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with acute decompensated heart failure

Patients presenting with acute decompensated heart failure (ADHF) at Saarland University Medical Center. (phase A)

ADHF (acutely decompensated CHF or new onset/ de novo HF):

Evidence of congestion and decompensation defined by physical abnormalities as follows: Physical evidence of congestion, including pitting edema > 2 mm in the lower extremities extending from the ankles to mid-calf and rales on pulmonary examination (chest X-ray)

Recompensation (guideline directed medical therapy)

Intervention Type: DRUG

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

Patients after recompensation

Same patients after recompensation. (phase B)

After resolution of the signs of congestion (mainly achieved by intravenous diuretics and/or vasodilators but no requirement for positive inotropic drugs such as catecholamines or levosimendan), as evidenced by the following:

1. A decrease in body weight and

2. Resolution of the physical findings (absence of signs) of congestion, including resolution of the physical findings of congestion including peripheral edema and rales on pulmonary examination (chest X-ray) according to the clinical judgment of the attending physician.

No interventions assigned to this group

Interventions

Recompensation (guideline directed medical therapy)

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universität des Saarlandes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Homburg, , Germany

Countries

Germany

Other Identifiers

BISO-ADHF

Identifier Type: -

Identifier Source: org_study_id