Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function

NCT07186062 | Completed FDA Drug

• 1 other identifier: FMASU MD 185a/2022/2023
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Decompensated Heart Failure (ADHF); Cardiorenal Syndrome (CRS)

Keywords

Levosimendan; dobutamine; Milrinone; Acute Decompensated Heart Failure (ADHF); Cardiorenal Syndrome (CRS)

Outcome Measures

Primary Outcomes (8)

• renal function parameters.

  Changes in serum creatinine (mg/dl). Pre- and post-infusion values were compared to assess treatment response.

  7 days

• renal function

  Changes in serum BUN (mg/dl). Pre- and post-infusion values were compared to assess treatment response.

  7 days

• renal function

  Changes in eGFR (mL/min/1.73 m²). Pre- and post-infusion values were compared to assess treatment response.

  7 days

• renal function

  Changes in urine output (mL/day). Pre- and post-infusion values were compared to assess treatment response.

  7 days

• cardiac function

  changes in ejection fraction % by transthoracic echocardiography. Pre- and post-infusion values were compared to assess treatment response.

  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.

  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.

  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.

  7 days

Secondary Outcomes (4)

• morbidity

  28 day

• morbidity

  28 day

• morbidity

  28 day

• mortality

  28 day

Study Arms (3)

Levosimendan group

Drug: Levosimendan

Dobutamine group

Drug: Dobutamine

Milrinone group

Drug: Milrinone

Interventions

Levosimendan DRUG

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.

Levosimendan group

Dobutamine DRUG

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.

Dobutamine group

Milrinone DRUG

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.

Milrinone group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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) \[10\] and require inotropic support.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of medicine Ain shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Cardio-Renal Syndrome

Interventions

Simendan; Dobutamine; Milrinone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Catecholamines; Amines; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Amrinone; Aminopyridines; Pyridines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 22, 2025
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

EG (1)