Acute Decompensated Heart Failure (ADHF)Phase 4NCT07186062
Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function
A Phase 4 study testing Levosimendan, Dobutamine and Milrinone in people with Acute Decompensated Heart Failure (ADHF) and Cardiorenal Syndrome (CRS), run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aimed to assess and compare the cardiac, renal, and clinical efficacy of Levosimendan (LEV), Dobutamine (DOB), and milrinone (MIL) in cases with acute decompensated heart failure (ADHF) complicated by renal impairment, with a focus on their role in the management of cardiorenal syndrome (CRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Decompensated Heart Failure (ADHF), Cardiorenal Syndrome (CRS)
- What is being tested?
- Levosimendan, Dobutamine and Milrinone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2022to 1 Jun 2024
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years old) patients with ADHF (LVEF ≤ 40% documented prior to enrollment) admitted to the ICU with renal impairment (estimated GFR between 30 and 60 mL/min/1.73 m², calculated using the Modification of Diet in Renal Disease Study equation (MDRD equation)) and require inotropic support.
Who cannot join
- Cases were excluded from the study if they met any of the following criteria:
- Age younger than 18 years
- Untreated acute HF
- Resting heart rate exceeding 120 beats per minute
- Recent MI or acute coronary syndrome within the previous two months
- Diagnosed pulmonary embolism
Show all 11Show fewer
- Structural cardiac conditions
- Known history of kidney disease diagnosed prior to HF
- Administration of contrast agents or nephrotoxic drugs within the previous seven days
- Severe liver dysfunction (Child C)
- Active acute inflammatory or infectious diseases.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to assess and compare the cardiac, renal, and clinical efficacy of Levosimendan (LEV), Dobutamine (DOB), and milrinone (MIL) in cases with acute decompensated heart failure (ADHF) complicated by renal impairment, with a focus on their role in the management of cardiorenal syndrome (CRS).
Read the detailed description
Methods Upon ICU admission and once the clinical decision to initiate inotropic therapy was made, all enrolled patients underwent a standardized evaluation protocol that included: Comprehensive medical history and clinical examination. Laboratory assessments, including Complete blood count (CBC), Arterial blood gases (ABG), Liver and kidney function tests, Serum electrolytes, Random blood glucose, Estimated glomerular filtration rate (eGFR). Cardiac parameters were recorded by EV1000 clinical platform device to assess the cardiac index (CI), stroke volume variations (SVV), and systemic vascular resistance index (SVRI). at baseline, 24 hours after inotropic therapy initiation, and again on day 7 or prior to ICU discharge whichever occurred first. Renal function indicators _including serum creatinine, blood urea nitrogen (BUN), eGFR, and urinary output_ were measured before the start of infusion and monitored daily until ICU discharge or death.
Medications were routinely administered as part of standard institutional practice. Where trial-specific medications were used, we have provided a clear distinction between these and routine medications. omission of medications not routinely used in our protocol did not cause harm to patients, and all treatments provided were in accordance with current safety standards and ethical guidelines.
Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg :
- Levosimendan: loading dose 6-12 microgram/ kg then continuous infusion of 0.05-0.2 µg/kg/min.
- Dobutamine: continuous infusion starting at 2.5 µg/kg/min, titrated up to 20 µg/kg/min as needed.
- Milrinone: 50 mcg/kg loading dose, then 0.375-0.75 mcg/kg/min IV according to patient response.
Primary outcomes included changes in cardiac and renal function parameters. Pre- and post-infusion values were compared to assess treatment response.
Secondary outcomes encompassed length of ICU stay, total hospital stay, ICU readmission, and all-cause in-hospital mortality.
- Being tested
- Levosimendan, Dobutamine, Milrinone
- Keywords
- Levosimendan, dobutamine, Milrinone, Acute Decompensated Heart Failure (ADHF), Cardiorenal Syndrome (CRS)
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevosimendanDrug
Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg :
•Levosimendan: loading dose 6-12 microgram/ kg then continuous infusion of 0.05-0.2 µg/kg/min.
DobutamineDrug
Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg :
- Dobutamine: continuous infusion starting at 2.5 µg/kg/min, titrated up to 20 µg/kg/min as needed.
MilrinoneDrug
Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg :
- Milrinone: 50 mcg/kg loading dose, then 0.375-0.75 mcg/kg/min IV according to patient response.
| Study group | Role | What they receive |
|---|---|---|
| Levosimendan group | Active comparator | Not described Receives: Drug: Levosimendan |
| Dobutamine group | Active comparator | Not described Receives: Drug: Dobutamine |
| Milrinone group | Active comparator | Not described Receives: Drug: Milrinone |
What is being measured
The primary outcome is the main question the study is designed to answer.
renal function parameters.
Changes in serum creatinine (mg/dl). Pre- and post-infusion values were compared to assess treatment response.
Measured: 7 days
renal function
Changes in serum BUN (mg/dl). Pre- and post-infusion values were compared to assess treatment response.
Measured: 7 days
renal function
Changes in eGFR (mL/min/1.73 m²). Pre- and post-infusion values were compared to assess treatment response.
Measured: 7 days
renal function
Changes in urine output (mL/day). Pre- and post-infusion values were compared to assess treatment response.
Measured: 7 days
cardiac function
changes in ejection fraction % by transthoracic echocardiography. Pre- and post-infusion values were compared to assess treatment response.
Measured: 7 days
cardiac function
Changes in cardiac index (L/min/m²) measured by EV1000 clinical platform device. Pre- and post-infusion values were compared to assess treatment response.
Measured: 7 days
cardiac function
changes in stroke volume variations (SVV) measured by EV1000 clinical platform. Pre- and post-infusion values were compared to assess treatment response.
Measured: 7 days
cardiac function
changes in systemic vascular resistance index (SVRI) using EV1000 clinical platform device. Pre- and post-infusion values were compared to assess treatment response.
Measured: 7 days
Secondary outcomes (4)
morbidity
length of ICU stay (days).
Measured: 28 day
morbidity
Total hospital stay (days)
Measured: 28 day
morbidity
ICU readmission
Measured: 28 day
mortality
In-hospital mortality.
Measured: 28 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jun 2022
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated Heart Failure (ADHF)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdou, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186062
- Sponsor's protocol ID
- FMASU MD 185a/2022/2023
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT07186062
- Acronym / sponsor ID
- FMASU MD 185a/2022/2023
- Keywords
- Levosimendan, dobutamine, Milrinone, Acute Decompensated Heart Failure (ADHF), Cardiorenal Syndrome (CRS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 22 Sep 2025 (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.
This study aimed to assess and compare the cardiac, renal, and clinical efficacy of Levosimendan (LEV), Dobutamine (DOB), and milrinone (MIL) in cases with acute decompensated heart failure (ADHF) complicated by renal impairment, with a focus on their role in the management of cardiorenal syndrome (CRS).
Detailed description
Methods Upon ICU admission and once the clinical decision to initiate inotropic therapy was made, all enrolled patients underwent a standardized evaluation protocol that included: Comprehensive medical history and clinical examination. Laboratory assessments, including Complete blood count (CBC), Arterial blood gases (ABG), Liver and kidney function tests, Serum electrolytes, Random blood glucose, Estimated glomerular filtration rate (eGFR). Cardiac parameters were recorded by EV1000 clinical platform device to assess the cardiac index (CI), stroke volume variations (SVV), and systemic vascular resistance index (SVRI). at baseline, 24 hours after inotropic therapy initiation, and again on day 7 or prior to ICU discharge whichever occurred first. Renal function indicators _including serum creatinine, blood urea nitrogen (BUN), eGFR, and urinary output_ were measured before the start of infusion and monitored daily until ICU discharge or death.
Medications were routinely administered as part of standard institutional practice. Where trial-specific medications were used, we have provided a clear distinction between these and routine medications. omission of medications not routinely used in our protocol did not cause harm to patients, and all treatments provided were in accordance with current safety standards and ethical guidelines.
Inotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg :
- Levosimendan: loading dose 6-12 microgram/ kg then continuous infusion of 0.05-0.2 µg/kg/min.
- Dobutamine: continuous infusion starting at 2.5 µg/kg/min, titrated up to 20 µg/kg/min as needed.
- Milrinone: 50 mcg/kg loading dose, then 0.375-0.75 mcg/kg/min IV according to patient response.
Primary outcomes included changes in cardiac and renal function parameters. Pre- and post-infusion values were compared to assess treatment response.
Secondary outcomes encompassed length of ICU stay, total hospital stay, ICU readmission, and all-cause in-hospital mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Levosimendan group | Active comparator | Drug: Levosimendan |
| Dobutamine group | Active comparator | Drug: Dobutamine |
| Milrinone group | Active comparator | Drug: Milrinone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (>18 years old) patients with ADHF (LVEF ≤ 40% documented prior to enrollment) admitted to the ICU with renal impairment (estimated GFR between 30 and 60 mL/min/1.73 m², calculated using the Modification of Diet in Renal Disease Study equation (MDRD equation)) and require inotropic support.
Key exclusion criteria (11 listed)
- Age younger than 18 years
- Untreated acute HF
- Resting heart rate exceeding 120 beats per minute
- Recent MI or acute coronary syndrome within the previous two months
- Diagnosed pulmonary embolism
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 |
|---|---|---|
| LevosimendanInotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg : •Levosimendan: loading dose 6-12 microgram/ kg then continuous infusion of 0.05-0.2 µg/kg/min. | Drug | Levosimendan group |
| DobutamineInotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg : • Dobutamine: continuous infusion starting at 2.5 µg/kg/min, titrated up to 20 µg/kg/min as needed. | Drug | Dobutamine group |
| MilrinoneInotropic agents titrated to response to keep mean arterial blood pressure above 55 mmHg : • Milrinone: 50 mcg/kg loading dose, then 0.375-0.75 mcg/kg/min IV according to patient response. | Drug | Milrinone group |
Primary outcome
renal function parameters.
Time frame: 7 days
Changes in serum creatinine (mg/dl). Pre- and post-infusion values were compared to assess treatment response.
renal function
Time frame: 7 days
Changes in serum BUN (mg/dl). Pre- and post-infusion values were compared to assess treatment response.
renal function
Time frame: 7 days
Changes in eGFR (mL/min/1.73 m²). Pre- and post-infusion values were compared to assess treatment response.
renal function
Time frame: 7 days
Changes in urine output (mL/day). Pre- and post-infusion values were compared to assess treatment response.
cardiac function
Time frame: 7 days
changes in ejection fraction % by transthoracic echocardiography. Pre- and post-infusion values were compared to assess treatment response.
cardiac function
Time frame: 7 days
Changes in cardiac index (L/min/m²) measured by EV1000 clinical platform device. Pre- and post-infusion values were compared to assess treatment response.
cardiac function
Time frame: 7 days
changes in stroke volume variations (SVV) measured by EV1000 clinical platform. Pre- and post-infusion values were compared to assess treatment response.
cardiac function
Time frame: 7 days
changes in systemic vascular resistance index (SVRI) using EV1000 clinical platform device. Pre- and post-infusion values were compared to assess treatment response.
4 secondary outcomes
morbidity
Time frame: 28 day
morbidity
Time frame: 28 day
morbidity
Time frame: 28 day
mortality
Time frame: 28 day
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 21 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 4 study testing Levosimendan, Dobutamine and Milrinone in people with Acute Decompensated Heart Failure (ADHF) and Cardiorenal Syndrome (CRS), run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 11 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 21 Sep 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
renal function parameters. (time frame: 7 days). The study lists 8 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 21 Sep 2026.