Clinical Trials

Numerous clinical trials evaluate dobutamine hydrochloride across a range of cardiovascular and critical care conditions, such as acute heart failure, cardiogenic shock, septic shock, valvular deficiencies, and transthyretin amyloid cardiomyopathy. These investigations span Early Phase 1 through Phase 4, with recruitment statuses ranging from completed and active to suspended or withdrawn. They receive support from diverse sponsors, including pharmaceutical companies, academic institutions, and government entities.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06878742 RECRUITING
Infant, Premature, Diseases; Circulatory and Respiratory Physiological Phenomena
Instituto de Investigación Hospital Universitario La Paz
 2024-06-24 PHASE1; PHASE2
NCT07406477 NOT_YET_RECRUITING
Hypoxic-ischemic Encephalopathy (HIE)
University of Alberta
 2026-07-15 PHASE2
NCT05944146 RECRUITING
Cardiac Surgery
Shanghai Zhongshan Hospital
 2023-05-31
NCT05267886 RECRUITING
Shock, Cardiogenic
Ottawa Heart Institute Research Corporation
 2022-03-05 PHASE4
NCT06318260 RECRUITING
ATTR Amyloidosis Wild Type
Steen Hvitfeldt Poulsen
 2024-04-08 PHASE1; PHASE2
NCT06372301 COMPLETED
Transthyretin Amyloid Cardiomyopathy; Aortic Stenosis
Steen Hvitfeldt Poulsen
 2024-04-02
NCT07000994 COMPLETED
Intraoperative Myocardial Depression
University of Hamburg-Eppendorf
 2025-06-16
NCT05953142 UNKNOWN
Sepsis; Hypoperfusion; Hyperlactatemia
Federal University of São Paulo
 2024-02-01 PHASE2
NCT06462313 COMPLETED
Patients With Septic Shock; Surgical Patients; General Anesthesia
First Affiliated Hospital of Zhejiang University
 2024-06-18
NCT03289728 TERMINATED
Myocardial Infarction
University Hospital, Grenoble
 2018-04-04
NCT04166331 COMPLETED
Sepsis; Cardiomyopathies; Hypoperfusion; Left Ventricular Systolic Dysfunction
University Hospital, Limoges
 2020-09-20 PHASE3
NCT05350592 ACTIVE_NOT_RECRUITING
Acute Myocardial Infarction; Cardiogenic Shock
Rigshospitalet, Denmark
 2022-03-13 PHASE2
NCT05797584 UNKNOWN
Heart Failure
Istituto Auxologico Italiano
 2019-03-20
NCT05587400 UNKNOWN
Pulmonary Arterial Hypertension; Right Ventricular Dysfunction
Shanghai Zhongshan Hospital
 2022-07-27
NCT04102072 UNKNOWN
Extracorporeal Membrane Oxygenation
Shanghai Zhongshan Hospital
 2019-08-23
NCT05025644 UNKNOWN
Hypertrophic Obstructive Cardiomyopathy
University Health Network, Toronto
 2023-03 PHASE4
NCT04604886 UNKNOWN
Cardiac Surgery; Cardiac Output
Shanghai Zhongshan Hospital
 2020-09-30
NCT04020172 COMPLETED
Perioperative Tissue Oxygenation
Dr. Glenio Mizubuti (MD, PhD)
 2019-07-12 PHASE1; PHASE2
NCT06210217 UNKNOWN
Laparoscopic Hepatectomy
Sichuan University
 2024-02-01 EARLY_PHASE1
NCT05196815 COMPLETED
Cardiovascular Abnormalities
The Royal Wolverhampton Hospitals NHS Trust
 2022-07-01
NCT05999487 UNKNOWN
Dobutamine, Milrinone , Pediatrics , Low Cardiac Output
Cairo University
 2023-10
NCT03437421 COMPLETED
Diabetes Complications; Vitamin D Deficiency; Vitamin D Supplementation; Myocardial Dysfunction
University of Avignon
 2018-02-04
NCT02327455 WITHDRAWN
Coronary Artery Disease
Yale University
 2023-07
NCT03661827 COMPLETED
Heart Failure; Coronary Artery Disease; Cardiac MRI
University of Leicester
 2019-02-05
NCT04893655 COMPLETED
General Anesthesia
University Hospital, Ghent
 2021-09-14 PHASE4
NCT03621618 WITHDRAWN
Sepsis; Cardiac Failure Acute
Universitair Ziekenhuis Brussel
 2019-03-31
NCT05241912 UNKNOWN
Burn Surgery; Dobutamine
Guangzhou Red Cross Hospital
 2022-02-28 EARLY_PHASE1
NCT05594342 UNKNOWN
Heart Failure; Cardiogenic Shock; Ischemic Heart Disease
The Young Investigator Group of Cardiovascular Research
 2022-07-01 PHASE3
NCT03996499 UNKNOWN
Coronary Disease
Fondation Hôpital Saint-Joseph
 2019-06-20
NCT04249258 COMPLETED
Arrhythmias, Cardiac
Northwell Health
 2020-01-14 EARLY_PHASE1
NCT03846765 COMPLETED
Nfuence of Vasoactive Medication on Spinal Oxygenation
University Hospital, Ghent
 2019-07-04 PHASE4
NCT03617406 COMPLETED
Aortic Valve Stenosis
Insel Gruppe AG, University Hospital Bern
 2018-05-31
NCT01042873 UNKNOWN
Healthy; Heart Failure
Hadassah Medical Organization
 2010-01 PHASE4
NCT03207165 COMPLETED
Low Cardiac Output Syndrome; Cardiogenic Shock; Acute Coronary Syndrome; Pulmonary Edema
Ottawa Heart Institute Research Corporation
 2017-08-30 PHASE4
NCT03098680 TERMINATED
Drug-Related Side Effects and Adverse Reactions; Cardiovascular System Disease
Cambridge University Hospitals NHS Foundation Trust
 2017-04-24 PHASE1
NCT03727282 UNKNOWN
Cardiogenic Shock; Heart Failure
University of Sao Paulo General Hospital
 2019-01-02
NCT03387605 UNKNOWN
Heart Failure; Cardiogenic Shock; Tachycardia
Loyola University
 2018-03-15 PHASE4
NCT03340779 UNKNOWN
Cardiogenic Shock
Central Hospital, Nancy, France
 2018-01-15 PHASE3
NCT02756000 COMPLETED
Myocardial Infarction
Clinical Hospital Center Zemun
 2016-01
NCT02767024 WITHDRAWN
Acute Heart Failure
Montefiore Medical Center
 2018-05-01 PHASE4
NCT02963454 UNKNOWN
Septic Shock
Military Hospital of Tunis
 2011-01
NCT03365726 COMPLETED
Mortality After Major Non Cardiac Surgery
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2016-01-19
NCT02505451 COMPLETED
Diabetes-related Complications
University of Avignon
 2015-07
NCT02726620 COMPLETED
Hypotension
Vanderbilt University Medical Center
 2017-01-05
NCT02522481 COMPLETED
Coronary Artery Disease
Bracco Diagnostics, Inc
 2015-09-24 PHASE3
NCT02552238 COMPLETED
Coronary Artery Disease
Bracco Diagnostics, Inc
 2015-10-12 PHASE3
NCT02133105 COMPLETED
Cardiorenal Syndrome
Göteborg University
 2014-04 PHASE3
NCT03288051 COMPLETED
Optimal Tissue Perfusion
Szeged University
 2014-04-28
NCT02510677 COMPLETED
Heart Failure
University Hospital, Caen
 2013-06
NCT02644057 WITHDRAWN
Cardiorenal Syndrome
Maimonides Medical Center
 2016-03 PHASE2
NCT02019810 UNKNOWN
Severe Traumatic Brain Injury With High Cerebral Pressure
University Hospital, Grenoble
 2014-10 PHASE2
NCT02361801 COMPLETED
Cardiac Output, Low; Coronary Disease
University of Sao Paulo
 2015-02 PHASE3
NCT00384540 COMPLETED
Vasculopathy; Allograft
University Hospital, Strasbourg, France
 2006-09
NCT03311178 TERMINATED
Shock
Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
 2014-05-30 PHASE1; PHASE2
NCT02559141 COMPLETED
Perioperative/Postoperative Complications; C.Surgical Procedure; Digestive System
University Hospital Schleswig-Holstein
 2014-03
NCT01930734 UNKNOWN
Heart Failure
Sheba Medical Center
 2013-10 PHASE4
NCT01427686 UNKNOWN
Arterial Hypotension
University of Ulm
 2011-06 PHASE4
NCT02668419 COMPLETED
Heart Failure; Ventricular Dysfunction, Left
Federal University of São Paulo
 2010-01
NCT01354613 COMPLETED
Heart Failure With Preserved Ejection Fraction; Pulmonary Disease; Left Ventricular Hypertrophy/Hypertension
University of Wisconsin, Madison
 2011-04
NCT02012946 UNKNOWN
Cardiovascular Diseases
Azienda Policlinico Umberto I
 2013-12 PHASE4
NCT01375335 SUSPENDED
Heart Failure
University of Aarhus
 2011-06 PHASE4
NCT00281255 WITHDRAWN
Cardiovascular Diseases; Cardiomyopathy, Dilated; Heart Diseases; Heart Failure, Congestive
University of Pennsylvania
 2003-06 PHASE1; PHASE2
NCT01969071 COMPLETED
Mitral Valve Stenosis With Incompetence or Regurgitation
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
 2009-07 PHASE4
NCT01271153 COMPLETED
Septic Shock
Pontificia Universidad Catolica de Chile
 2010-08
NCT01605279 COMPLETED
Hemodynamic Instability
Adelina Pellicer
 2010-09 PHASE2
NCT00580437 COMPLETED
Kidney Transplantation; Pancreas Transplantation
University of Nebraska
 2003-05-02
NCT00998205 COMPLETED
Diastolic Dysfunction
University of Missouri-Columbia
 2008-06
NCT00624650 COMPLETED
Acute Lung Injury
Oregon Health and Science University
 2008-02 PHASE2
NCT00763035 TERMINATED
Coronary Artery Disease; Asthma; Chronic Obstructive Pulmonary Disease (COPD); Angina
Wake Forest University Health Sciences
 2009-01 EARLY_PHASE1
NCT01418118 COMPLETED
Oral Cancer; Head and Neck Cancer; Free Flap; Hypotension
Oxford University Hospitals NHS Trust
 2008-10 PHASE4
NCT00549419 COMPLETED
Major Abdominal Surgery
Klinikum Ludwigshafen
 2007-10 PHASE4
NCT00484133 UNKNOWN
Severe Sepsis; Microcirculation
Onze Lieve Vrouwe Gasthuis
 2007-06 PHASE4
NCT00074724 COMPLETED
Cardiovascular Diseases; Coronary Disease; Heart Failure; Heart Failure, Congestive; Heart Diseases
Medstar Health Research Institute
 2003-05
NCT00557934 COMPLETED
Right Ventricular Dysfunction
University Hospital Tuebingen
 2007-10
NCT00800306 COMPLETED
Septic Shock
University of Roma La Sapienza
 2007-11 PHASE2
NCT00338455 TERMINATED
Congestive Heart Failure; Cardiac Transplantation; Renal Insufficiency; Renal Failure
Scios, Inc.
 2006-09 PHASE2
NCT00000554 COMPLETED
Angina Pectoris; Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
University of Pittsburgh
 2001-05 PHASE3
NCT00487812 COMPLETED
Ischemic Heart Disease; Myocardial Infarction
University Hospital, Clermont-Ferrand
 2004-12
NCT00148278 COMPLETED
Septic Shock; Severe Sepsis; Infections
University of Versailles
 1999-10 PHASE2; PHASE3
NCT00348504 COMPLETED
Acute Heart Failure
Abbott
 2003-03 PHASE3
NCT00093301 UNKNOWN
Cardiogenic Shock; Septic Shock
Wentworth Area Health Services
 2004-10 PHASE2; PHASE3
NCT00001891 COMPLETED
Coronary Disease; Heart Diseases
National Heart, Lung, and Blood Institute (NHLBI)
 1999-05 PHASE3
NCT00310622 UNKNOWN
Myocardial Ischemia
BSP Biological Signal Processing Ltd.
 2006-03 PHASE3
NCT00270400 COMPLETED
Heart Failure, Congestive
Scios, Inc.
 1998-08 PHASE3
NCT00001889 COMPLETED
Coronary Disease
National Heart, Lung, and Blood Institute (NHLBI)
 1999-03 PHASE2
NCT00100412 COMPLETED
Gulf War Syndrome; Chronic Fatigue Syndrome; Post-Traumatic Stress Disorder
US Department of Veterans Affairs
 1999-10

(data from https://clinicaltrials.gov, updated on 2025-03-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dobutamine hydrochloride selectively binds to and activates beta-1 adrenergic receptors, stimulating adenylate cyclase to elevate intracellular cyclic AMP levels and augment calcium influx in cardiomyocytes. This enhanced calcium mobilization increases myocardial contractility and cardiac output, thereby restoring systemic blood pressure in patients suffering from acute heart failure and cardiogenic shock.

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.