CLINICAL TRIALS PROFILE FOR DOBUTAMINE HYDROCHLORIDE

All Clinical Trials for Dobutamine Hydrochloride

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.
NCT00093301 ↗	Levosimendan Versus Dobutamine in Shock Patients	Unknown status	Abbott	Phase 2/Phase 3	2004-10-01	The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).
NCT00093301 ↗	Levosimendan Versus Dobutamine in Shock Patients	Unknown status	Wentworth Area Health Services	Phase 2/Phase 3	2004-10-01	The purpose of the study is to compare the efficacy of levosimendan with that of dobutamine in patients with unstable hemodynamics (shock).

Clinical Trial Conditions for Dobutamine Hydrochloride

Condition Name

Condition Name for Dobutamine Hydrochloride
Intervention	Trials
Heart Failure	13
Cardiogenic Shock	11
Septic Shock	10
Coronary Artery Disease	6

Condition MeSH

Condition MeSH for Dobutamine Hydrochloride
Intervention	Trials
Heart Failure	29
Shock	22
Shock, Cardiogenic	12
Shock, Septic	11

Clinical Trial Locations for Dobutamine Hydrochloride

Trials by Country

Trials by Country for Dobutamine Hydrochloride
Location	Trials
United States	57
France	47
Germany	13
Spain	8
United Kingdom	8

Trials by US State

Trials by US State for Dobutamine Hydrochloride
Location	Trials
New York	5
California	5
Texas	5
Missouri	4
Illinois	4

Clinical Trial Progress for Dobutamine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Dobutamine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	31
Phase 3	23
Phase 2/Phase 3	8

Clinical Trial Status

Clinical Trial Status for Dobutamine Hydrochloride
Clinical Trial Phase	Trials
Completed	60
Unknown status	17
Recruiting	14

Clinical Trial Sponsors for Dobutamine Hydrochloride

Sponsor Name

Sponsor Name for Dobutamine Hydrochloride
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
Sponsor	Trials
Other	163
Industry	22
NIH	6

Dobutamine Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Dobutamine Hydrochloride

Dobutamine hydrochloride is a short-acting intravenous sympathomimetic agent with positive inotropic and mild vasodilatory properties. It is widely used in the treatment of cardiac decompensation due to depressed contractility resulting from organic heart disease or cardiac surgical procedures.

Clinical Trials and Current Usage

Ongoing and Recent Clinical Trials

Several clinical trials are associated with dobutamine hydrochloride, focusing on its efficacy and safety in various clinical scenarios. For instance, a Phase 2 trial involves the use of dobutamine in combination with other agents like epinephrine, norepinephrine, phenylephrine, and vasopressin to manage conditions such as cardiogenic shock and low output syndromes[1].

Diagnostic Applications

Dobutamine is also used in diagnostic procedures like dobutamine stress echocardiography (DSE) to evaluate ischemia in patients unable to exercise. During DSE, dobutamine is administered in graded doses to achieve a target heart rate, typically 85% of the age-adjusted maximal heart rate[3].

Impact of the Dobutamine Shortage

Recently, a shortage of dobutamine has affected its availability, particularly impacting patients with advanced heart failure and other low output syndromes. This shortage has necessitated the use of alternative diagnostic and therapeutic modalities, such as MRI, PET, or SPECT imaging, until the supply is restored[3].

Market Analysis

Market Size and Growth

The dobutamine hydrochloride market has experienced significant growth in recent years and is projected to continue this upward trajectory. The market size is expected to expand substantially from 2023 to 2031, driven by increasing demand for inotropic support in cardiac care[2].

Market Segmentation

The market is segmented based on type (purity ≥ 98%, purity ≥ 99%) and application (injection solution, other). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own demand dynamics and market share[2].

Key Drivers and Restraints

• Drivers: The increasing prevalence of heart failure and the need for effective inotropic agents are key drivers of the market. Advances in cardiac care and the expanding use of dobutamine in various clinical scenarios also contribute to market growth.
• Restraints: The recent shortage of dobutamine and the lack of suitable pharmacological alternatives are significant restraints. Additionally, the risks associated with long-term use of cyclic-AMP-dependent inotropes, such as increased hospitalization and mortality rates, pose challenges[3][4].

Market Opportunities and Challenges

• Opportunities: The growing demand for cardiac care services and the potential for dobutamine to be used in new clinical applications present opportunities for market expansion.
• Challenges: The market faces challenges from regulatory pressures, competition from alternative diagnostic modalities, and the need to manage supply chain disruptions effectively[2][5].

Market Projections

Forecast Period

The market for dobutamine hydrochloride is forecasted to grow significantly from 2023 to 2031. This growth is anticipated across various regions, with Asia-Pacific expected to be a key growth driver due to its large population and increasing healthcare expenditure[2].

Revenue Projections

The revenue from the dobutamine hydrochloride market is projected to increase substantially, measured in USD million. The report provides a detailed analysis of the revenue projections across different segments, including type and application[2].

Regional Analysis

The market analysis includes a comprehensive regional breakdown, highlighting the supply and demand dynamics, key players, and market share in each region. North America and Europe are expected to remain significant markets, while Asia-Pacific is anticipated to show the highest growth rate[5].

Industry Chain Analysis

Upstream/Suppliers Analysis

The report includes an analysis of the upstream suppliers, focusing on technology, cost, and market channel analysis. This helps in understanding the raw material sourcing and manufacturing processes involved in producing dobutamine hydrochloride[5].

Downstream Buyers/End Users

The downstream analysis covers the demand from end-users, including hospitals, cardiac care centers, and other healthcare facilities. It also examines the competition among suppliers and the pricing strategies in different regions[5].

Latest Market Dynamics

Latest News and Developments

The market is influenced by recent news and developments, such as mergers and acquisitions, planned projects, and policy changes. These factors can impact the supply chain, pricing, and overall market dynamics[5].

Merger and Acquisition

The report includes information on any recent mergers and acquisitions that could affect the market landscape, including changes in market share and competitive dynamics[5].

Trading Analysis

Export and Import Analysis

The trading analysis covers the export and import of dobutamine hydrochloride by region, providing insights into the balance of trade and the global supply chain. This helps in understanding the market's global reach and dependencies[5].

Key Takeaways

• Clinical Trials: Ongoing trials focus on the efficacy and safety of dobutamine hydrochloride in various clinical scenarios.
• Market Growth: The market is projected to grow significantly from 2023 to 2031, driven by increasing demand for inotropic support.
• Market Segmentation: The market is segmented by type, application, and geography, with each segment showing distinct growth patterns.
• Drivers and Restraints: Increasing prevalence of heart failure and advances in cardiac care drive the market, while shortages and long-term use risks pose challenges.
• Regional Analysis: Asia-Pacific is expected to be a key growth driver, while North America and Europe remain significant markets.

FAQs

What is the primary use of dobutamine hydrochloride in clinical settings?

Dobutamine hydrochloride is primarily used for inotropic support in the short-term treatment of patients with cardiac decompensation due to depressed contractility resulting from organic heart disease or cardiac surgical procedures.

How has the recent shortage of dobutamine hydrochloride impacted clinical practice?

The shortage has significantly impacted patients with advanced heart failure and other low output syndromes, necessitating the use of alternative diagnostic and therapeutic modalities until the supply is restored.

What are the key drivers of the dobutamine hydrochloride market?

The increasing prevalence of heart failure and the need for effective inotropic agents are key drivers of the market, along with advances in cardiac care and expanding clinical applications.

What regions are expected to show significant growth in the dobutamine hydrochloride market?

Asia-Pacific is anticipated to be a key growth driver, while North America and Europe are expected to remain significant markets.

Can dobutamine hydrochloride be used for long-term treatment of heart failure?

No, dobutamine hydrochloride has not been shown to be safe or effective for the long-term treatment of congestive heart failure. In fact, long-term use is associated with increased risks of hospitalization and death.

Sources

1. Patsnap: Dobutamine Hydrochloride - Drug Targets, Indications, Patents.
2. Market Research Intellect: Global Dobutamine Hydrochloride Market Size, Trends and Forecast.
3. American College of Cardiology: Guidance For Clinicians on Dobutamine Shortage.
4. Drugs.com: Dobutamine in Dextrose: Package Insert / Prescribing Info.
5. Market Publishers: 2018 Global Dobutamine Hydrochloride Industry Report - History, Present and Future.

Last updated: 2025-01-01