Understanding how bisoprolol and SGLT2 inhibitors work in patients with acute 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)
This study is testing how well bisoprolol and SGLT2 inhibitors work for people with acute heart failure to see if they are safe and effective in improving their condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universität des Saarlandes Academic / other |
| Locations | 1 site (Homburg) |
| Trial ID | NCT06453577 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients with decompensated heart failure, regardless of ejection fraction, who have previously been on beta-blocker therapy.
Not a fit: Patients in cardiogenic shock or those requiring inotropic support are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with acute decompensated heart failure.
How similar studies have performed: While this specific approach is novel, there is existing evidence suggesting potential safety and benefits of SGLT2i in heart failure management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Homburg
- Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University — Homburg, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.