Understanding how bisoprolol and SGLT2 inhibitors work in patients with acute heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate the pharmacokinetics and pharmacodynamics of bisoprolol and sodium-glucose co-transporter-2 inhibitors (SGLT2i) in patients experiencing acute decompensated heart failure. It will compare the effects of these medications in patients who are decompensated versus those who have been recompensated. The study will focus on the safety and hemodynamic effects of continuing established beta-blocker therapy and SGLT2i treatment in this patient population. The findings could provide essential data for dose recommendations and treatment protocols.

Why it matters

Who can join: the full rules

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

Where it's running

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.