Clinical Trials

Milrinone is evaluated across numerous clinical trials spanning Phase 1 through Phase 4, targeting conditions such as heart failure, persistent pulmonary hypertension, congenital heart defects, and perioperative hemodynamic support. Sponsored by diverse entities including academic medical centers, university hospitals, and specialized institutions, these studies reflect recruitment statuses ranging from completed pediatric and neonatal protocols to actively recruiting trials assessing nebulized administration in adult cardiac anesthesia.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07643922 RECRUITING
Subarachnoid Hemorrhage, Aneurysmal; Cerebral Vasospasm After Subarachnoid Hemorrhage
Beijing Tiantan Hospital
 2026-06-03
NCT05450328 RECRUITING
Right Heart Failure; Right Ventricular Dysfunction
Montreal Heart Institute
 2025-12-10 PHASE2
NCT07144267 NOT_YET_RECRUITING
Cardiac Anaesthesia; Cardiopulmonary Bypass
Mansoura University
 2026-03-01
NCT05700617 RECRUITING
Heart Failure; Cardiogenic Shock
University of Chicago
 2023-07-06 EARLY_PHASE1
NCT06679855 RECRUITING
Post-ligation Cardiac Syndrome
NICHD Neonatal Research Network
 2025-06-13 PHASE3
NCT05267886 RECRUITING
Shock, Cardiogenic
Ottawa Heart Institute Research Corporation
 2022-03-05 PHASE4
NCT04362527 COMPLETED
Vasospasm
University Hospital, Angers
 2020-08-10 PHASE3
NCT04282629 RECRUITING
Aneurysmal Subarachnoid Hemorrhage
University Hospital, Toulouse
 2021-07-25 PHASE2
NCT04484675 RECRUITING
Pulmonary Hypertension Due to Left Heart Disease
Zagazig University
 2023-05-20 PHASE4
NCT05838846 COMPLETED
Mitral Valve Replacement; Pulmonary Hypertension; Inhaled Milrinone; Intravenous Milrinone
Menoufia University
 2023-04-01 PHASE2; PHASE3
NCT06685679 COMPLETED
Neonatal Diseases and Abnormalities; Neonatal Mortality; Pulmonary Arterial Hypertension; Pulmonary Arterial Hypertension, Children
Ain Shams University
 2024-05-15 PHASE3
NCT05122884 UNKNOWN
Septic Shock; Cardiac Output
Mahidol University
 2021-12-01 PHASE2
NCT02951130 COMPLETED
Congenital Diaphragmatic Hernia; Persistent Pulmonary Hypertension of the Newborn; Hypoxemic Respiratory Failure; Pulmonary Hypoplasia
NICHD Neonatal Research Network
 2017-10-24 PHASE2
NCT06562036 COMPLETED
Persistent Pulmonary Hypertension of the Newborn
Muhammad Aamir Latif
 2023-12-01
NCT05999487 UNKNOWN
Dobutamine, Milrinone , Pediatrics , Low Cardiac Output
Cairo University
 2023-10
NCT04718350 COMPLETED
Hypertension, Pulmonary; Cardiac Failure; Pulmonary Vascular Resistance Abnormality
Aretaieion University Hospital
 2021-01-27
NCT06032195 Active not recruiting
Heart Transplantation
Dr. F. Köhler Chemie GmbH
 2023-08-15 Phase 2
NCT02098629 COMPLETED
Myocardial Reperfusion Injury
Shantou University Medical College
 2015-05 PHASE2
NCT06301880 COMPLETED
Internal Mammary Artery Syndrome; Vasodilation
Damascus University
 2022-01-01 PHASE3
NCT02077010 COMPLETED
Heart Failure; Cardiomyopathy
University of Kansas Medical Center
 2020-06-15 PHASE1
NCT05132153 UNKNOWN
Anesthesia
Ain Shams University
 2021-10-17 PHASE4
NCT05131867 COMPLETED
Oral Nimodipine; Milrinone; Vascular Spasm After Traumatic Subarachnoidhaemorrhage
Zagazig University
 2021-11-24 PHASE2
NCT05830136 Recruiting
Hepatic Ischemia
The First Affiliated Hospital with Nanjing Medical University
 2022-02-01 Not Applicable
NCT05132153 Recruiting
Anesthesia
Ain Shams University
 2021-10-17 Phase 4
NCT03823781 UNKNOWN
Low Cardiac Output Syndrome; Cardiac Surgical Procedures; Infant
Shanghai Children's Medical Center
 2019-02 PHASE3
NCT01841177 COMPLETED
Congenital Heart Disease
The Hospital for Sick Children
 2013-04 PHASE2
NCT03207165 COMPLETED
Low Cardiac Output Syndrome; Cardiogenic Shock; Acute Coronary Syndrome; Pulmonary Edema
Ottawa Heart Institute Research Corporation
 2017-08-30 PHASE4
NCT03855579 UNKNOWN
Hemodynamics
Assiut University
 2019-03-06 PHASE4
NCT03945708 Completed
Infective Endocarditis
Emma Hansson|CytoSorbents Inc|Sahlgrenska University Hospital Sweden
 2019-05-15 Not Applicable
NCT02640846 UNKNOWN
Septic Shock; Cardiomyopathy
Sahlgrenska University Hospital
 2015-12 PHASE4
NCT02726620 COMPLETED
Hypotension
Vanderbilt University Medical Center
 2017-01-05
NCT02712788 TERMINATED
Cerebral Vasospasm
Indiana University
 2016-04-18 PHASE2
NCT02549066 COMPLETED
Complication of Extracorporeal Circulation; Kidney Circulation Disorder; Renal Function Disorder
Sahlgrenska University Hospital
 2016-01
NCT01956006 COMPLETED
Heart Failure
The Alfred
 2013-10-01 PHASE1; PHASE2
NCT02232399 COMPLETED
Congenital Heart Defects
Göteborg University
 2014-10-15 PHASE2
NCT02644057 WITHDRAWN
Cardiorenal Syndrome
Maimonides Medical Center
 2016-03 PHASE2
NCT02408003 COMPLETED
Heart Failure, Diastolic; Aortic Valve Stenosis; Monitoring, Physiologic; Physiology
Sahlgrenska University Hospital
 2014-03
NCT02595541 COMPLETED
Pulmonary Hypertension
Assiut University
 2015-06 PHASE1; PHASE2
NCT04391478 COMPLETED
Persistent Pulmonary Hypertension
Rania Ali El-Farrash
 2015-01 PHASE1
NCT01849094 COMPLETED
Healthy; Heart Failure
The Alfred
 2013-05 PHASE1; PHASE2
NCT01571037 COMPLETED
End Stage Heart Disease; Right Ventricular Dysfunction
University of Nebraska
 2012-04-05 PHASE1
NCT01088997 TERMINATED
Persistent Fetal Circulation Syndrome
Children's Hospital of Philadelphia
 2010-06
NCT00543309 TERMINATED
Heart Defects, Congenital
John M Costello
 2007-10 PHASE2
NCT01725776 COMPLETED
Pulmonary Hypertension
Montreal Heart Institute
 2006-12 PHASE2
NCT00819377 COMPLETED
Valvular Stenosis; Valvular Insufficiency; Hypertension, Pulmonary; Coronary Artery Disease
Andre Denault
 2009-02 PHASE2
NCT01576094 COMPLETED
Low Cardiac Output Syndrome
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
 2009-11 PHASE1; PHASE2
NCT00695929 COMPLETED
Congenital Cardiovascular Defects; Low Cardiac Output Syndrome
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
 2008-07
NCT00966745 COMPLETED
Hepatectomy
Seoul National University Hospital
 2008-01
NCT00338455 TERMINATED
Congestive Heart Failure; Cardiac Transplantation; Renal Insufficiency; Renal Failure
Scios, Inc.
 2006-09 PHASE2
NCT00446017 COMPLETED
Cardiac Output, Low
University of Luebeck
 2003-06 PHASE3
NCT01621971 COMPLETED
Pulmonary Hypertension; Mitral Regurgitation
Konkuk University Medical Center
 2003-01 PHASE3
NCT00549107 UNKNOWN
Low Cardiac Output Syndrome
Ludwig Boltzmann Gesellschaft
 2007-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-29)

Check the Milrinone product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Milrinone selectively inhibits phosphodiesterase 3 (PDE3), preventing the breakdown of cyclic adenosine monophosphate (cAMP) and elevating intracellular cAMP levels within cardiac myocytes and vascular smooth muscle cells. This accumulation enhances calcium ion uptake into the sarcoplasmic reticulum and promotes vascular relaxation, driving positive inotropic and vasodilatory responses that are essential for improving cardiac output in clinical settings such as acute heart failure, persistent pulmonary hypertension, and perioperative cardiac surgery.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.