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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recompensation (guideline directed medical therapy) | Drug | Recompensation mainly achieved by intravenous diuretics and/or vasodilators but no requirement for positive inotropic drugs such as catecholamines or levosimendan. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax in ng/ml] of Bisoprolol/ Dapagliflozin/ Empaglifozin | toxicological measurements (using liquid chromatography coupled to high-resolution mass spectrometry) of drug levels in venous blood in decompensated and recompensated state (Comparison decompensated and recompensated state) | up to 7 days |
| Plasma Concentration (in ng/ml) over time of Bisoprolol/ Dapaglifozin/ Empagliflozin (AUC= Area under the curve) | toxicological measurements (using liquid chromatography coupled to high-resolution mass spectrometry) of drug levels in venous blood in decompensated and recompensated state (Comparison decompensated and recompensated state) | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamic assessment (blood pressure in mmHg) of patients in decompensated and recompensated state | Pharmacodynamics of Bisoprolol and Dapagliflozin and Empagliflozin | up to 7 days |
| Hemodynamic assessment (heart rate in bpm) of patients in decompensated and recompensated state |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting with acute decompensated heart failure (ADHF) at the intensive care unit at Saarland University Medical Center
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University | Homburg | 66421 | Germany |
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Pharmacodynamics of Bisoprolol and Dapagliflozin and Empagliflozin |
| up to 7 days |