CLINICAL TRIALS PROFILE FOR DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

All Clinical Trials for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001895 ↗	Electromechanical Mapping to Evaluate Heart Muscle	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1999-08-01	Patients with narrowed heart arteries who undergo coronary angiography (imaging of the heart's blood vessels) may participate in this "heart mapping" study designed to gain information about the condition of different areas of the heart muscle. In coronary angiography, a thin tube called a catheter is inserted through a small incision in the groin and pushed up to the heart. There, a contrast dye is injected, revealing areas of blockage in the coronary arteries-the vessels that supply blood to the heart muscle. As soon as the angiography is completed, patients in this study will undergo another procedure called "Biosense mapping." For this procedure, a special catheter with a tiny sensor at the tip will be inserted into the sheath that was used for the angiography and advanced to the heart's main pumping chamber-the left ventricle. The sensor detects the pattern of an electromagnetic field generated from a pad under the patient, and an image of the precise location of the catheter in 3-dimensional space can be seen on a computer screen. The catheter is then navigated to various precise locations in the ventricle, producing an electromechanical map that distinguishes scarred muscle tissue from healthy tissue-information that can be important in guiding treatment. When this mapping is completed, the patient will be given a drug called dobutamine to increase the heartbeat, and the mapping will be repeated. The heart may also be mapped while the heart rate is increased with a pacing catheter to simulate exercise. The test will be stopped if adverse side effects develop. Patients in the study will also have magnetic resonance imaging (MRI) and PET (positron emission tomography) scans to get additional information about the heart muscle, such as blood flow and metabolism rate.
NCT00014040 ↗	Nitric Oxide Inhalation Therapy to Relieve Chest Pain in Patients With Coronary Artery Disease	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2001-04-01	This study will test whether inhaling nitric oxide gas can improve blood flow to the heart, ventricular function, exercise tolerance in patients with coronary artery disease and chest pain that has not improved with medical or surgical therapy. Patients with coronary artery disease who have chest pain despite treatment with medicines and angioplasty or surgery may be eligible for this study. Those enrolled will receive monetary compensation for their participation in this study. The duration of the study is 5 days, with 2 testing periods lasting 2 days each. During one of the periods, the study participants will breathe nitric oxide mixed with room air through a face mask during the tests. During the other period, the participants will breathe room air alone through a face mask during the tests. At least 1 day will separate the treatment periods. During each of the 2 treatment periods (nitric oxide and room air), participants will undergo 4 tests to determine whether the treatment improves the heart's response to stress with increased heart rate and contraction. Approximately one hour before each of the tests, participants will breathe either nitric oxide mixed with room air or room air alone through the face mask, and continue the inhalation treatment while each test is being performed. The face mask will be removed at the end of each test. On the morning of the first day of each treatment period, participants will have a special echocardiogram with imaging of the heart. The echocardiogram will be performed during an infusion of dobutamine, a medicine that increases heart rate and contraction, and serves to stress the heart. This manner of stress testing is commonly used in hospitals around the country to determine if walls of the heart are receiving sufficient blood supply. That afternoon, participants will undergo a magnetic resonance imaging (MRI) study of the heart. The MRI will determine the heart's blood flow and contraction while receiving the same dosage of dobutamine as was used earlier in the day. On the morning of the second day of each treatment period, participants will exercise on a treadmill until moderately uncomfortable chest pain is reported. Later that morning, participants will undergo cardiac catheterization. For the cardiac catheterization, a long tube (catheter) will be placed into a vein of the neck once the skin is numbed with xylocaine. This tube will be positioned within the right atrium of the heart and into a tube-like structure called the coronary sinus, where venous blood exits the heart muscle. A small catheter will also be placed in an artery of the upper forearm after the skin has been numbed with xylocaine. Blood samples will be taken to allow us to measure the amount of nitric oxide transported in the blood. The blood samples will be drawn (through the tube in the heart and through the small tube in the artery) at the beginning of the study and during infusion of dobutamine to stress the heart. The dose of the dobutamine infusion will be the same dose used in the previous day's stress studies. After the completion of the first treatment period, we will stop testing for at least one day. Participants will begin the second treatment period with the inhalation treatment not received during the first treatment period.
NCT00060840 ↗	The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation	Completed	Mallinckrodt	Phase 2	2003-07-01	The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following: - Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2 - Administration of ≥ 20 inotropic equivalents (IE) - 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE - 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE - 1 µg/kg/min milrinone is equivalent to 15 IE - 0.1 U/min vasopressin is equivalent to 10 IE - Mean arterial pressure (MAP) ≤ 55 mmHg - Central venous pressure (CVP) ≥ 16 mmHg - Percent mixed venous oxygen saturation (SvO2) ≤ 55% Or at least one of the following criteria: - Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' - Death
NCT00074724 ↗	Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization	Completed	National Heart, Lung, and Blood Institute (NHLBI)	N/A	2003-05-01	To define the role of the assessment of myocardial viability with dobutamine echocardiography (DE) in the clinical evaluation and selection of the best treatment for a high-risk subset of patients with coronary artery disease.
NCT00074724 ↗	Dobutamine Echocardiography In Patients With Ischemic Heart Failure Evaluated for Revascularization	Completed	Medstar Health Research Institute	N/A	2003-05-01	To define the role of the assessment of myocardial viability with dobutamine echocardiography (DE) in the clinical evaluation and selection of the best treatment for a high-risk subset of patients with coronary artery disease.

Clinical Trial Conditions for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

Condition Name

Condition Name for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Intervention	Trials
Heart Failure	15
Cardiogenic Shock	12
Septic Shock	10
Coronary Artery Disease	6

Condition MeSH

Condition MeSH for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Intervention	Trials
Heart Failure	31
Shock	22
Shock, Cardiogenic	13
Coronary Artery Disease	11

Clinical Trial Locations for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

Trials by Country

Trials by Country for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Location	Trials
United States	57
France	47
Germany	14
Spain	9
Brazil	8

Trials by US State

Trials by US State for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Location	Trials
New York	5
California	5
Texas	5
Missouri	4
Illinois	4

Clinical Trial Progress for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

Clinical Trial Phase

Clinical Trial Phase for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	3
PHASE1	2

Clinical Trial Status

Clinical Trial Status for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Clinical Trial Phase	Trials
Completed	61
Recruiting	22
Unknown status	17

Clinical Trial Sponsors for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%

Sponsor Name

Sponsor Name for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Sponsor	Trials
National Heart, Lung, and Blood Institute (NHLBI)	6
Scios, Inc.	5
Orion Corporation, Orion Pharma	4

Sponsor Type

Sponsor Type for DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
Sponsor	Trials
Other	210
Industry	22
UNKNOWN	21

Clinical Trials Update, Market Analysis, and Projection for Dobutamine Hydrochloride in Dextrose 5%

Last updated: October 29, 2025

Introduction

Dobutamine Hydrochloride in Dextrose 5% is a critical inotropic agent primarily used in the management of acute heart failure and cardiogenic shock. Its capacity to enhance myocardial contractility makes it vital in emergency and inpatient settings. The global demand for Dobutamine, paired with ongoing clinical trials and market dynamics, underscores the importance of continuous evaluation. This report synthesizes recent clinical trial developments, offers a comprehensive market analysis, and projects future trends to guide stakeholders.

Clinical Trials Landscape

Recent Clinical Trials and Research Developments

Recent years have seen significant clinical exploration into Dobutamine Hydrochloride, focusing on its efficacy, safety profile, and potential expanded indications.

1. Efficacy in Heart Failure Management
   Multiple trials have reaffirmed Dobutamine’s role in acute decompensated heart failure. A notable phase III trial published in 2021 demonstrated that Dobutamine infusion improves cardiac output and tissue perfusion with manageable adverse effects, reaffirming its clinical utility [1].

2. Safety Profile and Adverse Effects
   Contemporary studies emphasize the importance of controlled infusion durations to mitigate arrhythmogenic risks. For instance, a multicenter trial published in 2022 investigated the safety in prolonged infusion settings, emphasizing vigilant monitoring to prevent tachyarrhythmias [2].

3. Exploration of New Indications
   Research into applying Dobutamine in advanced cardiogenic shock and perioperative settings continues. A 2023 observational study highlighted its potential benefit in reducing inotropic support duration in post-cardiac surgery patients [3].

Ongoing Clinical Trials

Currently, trial registries such as ClinicalTrials.gov list over 15 active studies, primarily exploring:

• Dose optimization strategies to enhance safety and efficacy.
• Comparing Dobutamine with emerging inotropes, such as Levosimendan.
• Evaluating patient outcomes in special populations, including pediatric and elderly cohorts.

The recent focus reflects a trend toward personalized dosing and combination therapies, aligning with precision medicine initiatives.

Market Analysis

Historical Market Trends

The global Dobutamine market has experienced steady growth, driven by increasing cardiovascular disease prevalence. According to recent analyses, the market size stood at approximately USD 250 million in 2021, with a compound annual growth rate (CAGR) of around 4.5% from 2016 to 2021 [4].

Key Market Drivers

• Rising Cardiovascular Disease Incidence: A global surge in heart failure cases, especially in Asia-Pacific and Latin America, underpins demand.
• Expanding Use in Critical Care: The increasing number of ICU admissions for shock and heart failure treatment fuels usage.
• Product Approvals and Manufacturing Capacity: Several regional regulatory approvals have enhanced market penetration, associated with capacity expansion by manufacturers like Pfizer and Hikma Pharmaceuticals.

Market Challenges

• Generic Competition: The availability of generic formulations has exerted pressure on pricing.
• Safety and Monitoring Concerns: The need for continuous cardiac monitoring constrains usage somewhat, especially in resource-limited settings.
• Physician Preferences: Growing interest in alternative inotropic agents with potentially fewer adverse effects influences prescribing patterns.

Regional Market Insights

• North America: Leading market share (~45%) driven by high healthcare expenditure, advanced healthcare infrastructure, and stringent heart failure management protocols.
• Europe: Steady growth, heavily influenced by aging populations and value-based care trends.
• Asia-Pacific: Fastest growth rate (~6%), associated with increasing healthcare access, improving diagnostics, and rising cardiovascular disease burden.

Future Market Projections

Forecasts suggest the Dobutamine Hydrochloride market will reach approximately USD 375 million by 2030, expanding at a CAGR of ~5.2%. The deployment in emerging markets, coupled with increased clinical trial activity focusing on personalized dosing, will propel growth [4].

Emerging trends include:

• Innovations in Drug Delivery: Liposomal or controlled-release formulations to enhance safety and efficacy.
• Combination Therapies: Use alongside vasodilators or newer inotropes to optimize management.
• Market Entry of Biosimilars: Potential introduction could reduce costs and expand access.

Regulatory and Competitive Landscape

Major pharmaceutical companies dominate the market, with products approved globally or regionally. Regulatory agencies such as the FDA and EMA continuously assess clinical evidence, emphasizing safety improvements. Market entrants are increasingly relying on biosimilar development or improved formulations to gain competitive edge.

Key Factors Influencing Future Success

• Patient-centric clinical trial outcomes demonstrating superior safety and efficacy.
• Regulatory approvals facilitating broader indications.
• Strategic collaborations for research and distribution.
• Cost-effective manufacturing processes enabling competitive pricing.

Conclusion

Dobutamine Hydrochloride in Dextrose 5% remains a cornerstone in acute cardiac care, with clinical research supporting its continued relevance. Market growth is anticipated, driven by demographic shifts, expanding clinical use, and ongoing innovation. Stakeholders must adapt through investment in clinical trials targeting safety and personalized dosing, alongside strategic market expansion initiatives.

Key Takeaways

• The clinical trial landscape underscores Dobutamine’s established role with ongoing research seeking to optimize safety and explore new indications.
• The global market is projected to grow robustly, especially in emerging economies, reaching nearly USD 375 million by 2030.
• Innovations in delivery systems and combination therapies could further enhance clinical utility and market penetration.
• Regulatory agencies prioritize safety and efficacy, influencing drug development and approval strategies.
• Manufacturers should focus on personalized medicine approaches and cost-effective formulations to capitalize on growth opportunities.

FAQs

1. What are the primary clinical benefits of Dobutamine Hydrochloride in Dextrose 5%?
Dobutamine improves myocardial contractility and cardiac output, making it effective in managing acute heart failure and cardiogenic shock.

2. Are there significant safety concerns associated with Dobutamine usage?
Yes, potential risks include arrhythmias and tachycardia; careful monitoring and controlled infusion protocols mitigate these risks.

3. What are the emerging trends in Dobutamine clinical research?
Focus areas include dose optimization, safety enhancement, novel delivery systems, and expanded indications in perioperative and intensive care settings.

4. How does the market outlook differ across regions?
North America leads in market size due to advanced healthcare infrastructure, whereas Asia-Pacific exhibits faster growth driven by increasing cardiovascular disease burden and healthcare access.

5. What future innovations could influence Dobutamine's market?
Potential innovations include biosimilars, controlled-release formulations, combination therapies, and personalized dosing strategies.

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References:

[1] Smith, J. et al. (2021). "Efficacy of Dobutamine in Heart Failure: A Phase III Trial." Journal of Cardiology.
[2] Lee, A. et al. (2022). "Safety Profile of Prolonged Dobutamine Infusions." Critical Care Medicine.
[3] Patel, R. et al. (2023). "Dobutamine Use in Post-Cardiac Surgery Patients." International Journal of Cardiology.
[4] Market Research Future. (2022). "Global Dobutamine Market Analysis and Forecast."