Acute Decompensated Heart FailureBISO-ADHFNCT06453577
Pharmacokinetics of Bisoprolol and SGLT2i in Acutely Decompensated Heart Failure
An observational study of Acute Decompensated Heart Failure, run by Universität des Saarlandes at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Recompensation (guideline directed medical therapy)
- Type of treatment
- Injection or infusion
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2023to 8 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients presenting with acute decompensated heart failure (ADHF) at the intensive care unit at Saarland University Medical Center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University
Homburg, 66421
About this study
Official title: 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)
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
- Being tested
- Recompensation (guideline directed medical therapy)
- Keywords
- Acute Decompensated Heart Failure, Bisoprolol, SGLT2-inhibitors, Pharmacokinetics, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Recompensation (guideline directed medical therapy) | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: up to 7 days
Secondary outcomes (2)
Hemodynamic assessment (blood pressure in mmHg) of patients in decompensated and recompensated state
Pharmacodynamics of Bisoprolol and Dapagliflozin and Empagliflozin
Measured: up to 7 days
Hemodynamic assessment (heart rate in bpm) of patients in decompensated and recompensated state
Pharmacodynamics of Bisoprolol and Dapagliflozin and Empagliflozin
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 May 2023
- Primary completion1 May 2024
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453577
- Sponsor's protocol ID
- BISO-ADHF
- Acronym
- BISO-ADHF
- Status last verified
- Jul 2026
- First submitted
- 29 May 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06453577
- Acronym / sponsor ID
- BISO-ADHF / BISO-ADHF
- Conditions
- Acute Decompensated Heart Failure
- Keywords
- Acute Decompensated Heart Failure, Bisoprolol, SGLT2-inhibitors, Pharmacokinetics, Pharmacodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with acute decompensated heart failure | – | Drug: Recompensation (guideline directed medical therapy)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) |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with acute decompensated heart failure (ADHF) at the intensive care unit at Saarland University Medical Center
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Patients with acute decompensated heart failure |
Primary outcome
Maximum Plasma Concentration [Cmax in ng/ml] of Bisoprolol/ Dapagliflozin/ Empaglifozin
Time frame: up to 7 days
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)
Plasma Concentration (in ng/ml) over time of Bisoprolol/ Dapaglifozin/ Empagliflozin (AUC= Area under the curve)
Time frame: up to 7 days
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)
2 secondary outcomes
Hemodynamic assessment (blood pressure in mmHg) of patients in decompensated and recompensated state
Time frame: up to 7 days
Hemodynamic assessment (heart rate in bpm) of patients in decompensated and recompensated state
Time frame: up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Decompensated Heart Failure, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration [Cmax in ng/ml] of Bisoprolol/ Dapagliflozin/ Empaglifozin (time frame: up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.