What side effects are associated with this type of intervention?

Ultrasound contrast agents like Definity, used to enhance echocardiogram quality, are generally well-tolerated but can have side effects. Common side effects include headache, nausea, and dizziness. Rare but serious adverse effects may include hypersensitivity reactions, such as anaphylaxis, and cardiovascular events like arrhythmias. It is important for patients to discuss these potential risks with their healthcare provider before undergoing treatment.

What prior FDA approvals exist?

The FDA has approved several ultrasound contrast agents for the treatment of heart disease, specifically to improve the quality of echocardiograms by enhancing endocardial border delineation. One such agent is Definity (perflutren lipid microspheres), which is indicated for use in patients with suboptimal echocardiograms. Definity works by opacifying the left ventricular chamber, thereby improving the visualization of the left ventricular endocardial border. These agents are crucial in providing clearer images for better diagnosis and management of heart conditions.

What other types of research exist?

Promising alternatives to MVT-100 for enhancing echocardiogram quality include Definity (perflutren lipid microspheres), which is already established for this purpose. Additionally, advancements in T1 mapping and extracellular volume (ECV) fraction measurement using gadolinium-based contrast agents are emerging as effective methods for detailed cardiac imaging, particularly in conditions like cardiac amyloidosis. These techniques provide high diagnostic accuracy and can be useful in early disease detection and assessment.

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Ultrasound Contrast Agents for Heart Imaging

Q: What is the mechanism of action of this treatment?

Ultrasound contrast agents like MVT-100 and Definity improve echocardiogram quality by enhancing the delineation of the left ventricular endocardial border, which is essential for accurate diagnosis and management of heart disease. This precise imaging allows for better assessment of cardiac function and structure, leading to more effective treatment plans. Other common treatments for heart disease include ACE inhibitors, beta-blockers, and statins, which lower blood pressure, reduce heart workload, and manage cholesterol levels, respectively. These treatments help prevent complications such as heart attacks and strokes, thereby improving patient outcomes.

Phase 1 & 2

Recruiting

Research Sponsored by Microvascular Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate hematologic, renal and hepatic function, as defined by: Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L, Platelet count ≥ 100 x 10^9/L, Hemoglobin ≥ 90 g/L, Plasma creatinine< 1.5 x ULN, Total bilirubin within normal limits (< 2.5 x ULN if Gilbert's syndrome), Aspartate transaminase (AST) and Alanine transaminase (ALT) < 2.5 x ULN

Be older than 18 years old

Must not have

Clinically significant Chronic Obstructive Pulmonary Disease (COPD) or other pulmonary condition that is not controlled by medication or requires oxygen frequently or continuously

Unstable angina, NYHA Class II or greater congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day of study

Awards & highlights

No Placebo-Only Group

Approved for 5 Other Conditions

All Individual Drugs Already Approved

Summary

This trial tests MVT-100, a new ultrasound contrast agent, in healthy volunteers. It aims to see if MVT-100 is safe and effective for improving heart images by using tiny bubbles that reflect ultrasound waves. The study compares MVT-100 to an existing product.

Who is the study for?

Healthy adults over 19, who can't have children or will use birth control, with normal blood counts and organ function. Excluded are those with recent heart attacks, unstable angina, severe heart failure, significant arrhythmias in the last six months, allergies to similar drugs or soy/egg products, participation in other trials within 30 days, conditions making lying flat for an hour difficult or certain lung issues.

What is being tested?

The trial tests MVT-100 against Definity (both ultrasound contrast agents) in healthy volunteers using a single ascending dose method. Participants receive one of the two drugs and then undergo echocardiograms to assess safety and how well they help visualize the heart's inner lining during ultrasound.

What are the potential side effects?

Potential side effects may include allergic reactions due to similarities with other compounds or ingredients like soy/egg products. Specific side effects aren't listed but would likely relate to infusion reactions such as discomfort at injection site or imaging-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood, kidney, and liver tests are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe lung problems that aren't well-controlled by medication or need oxygen often.

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I do not have severe heart problems like unstable chest pain or heart failure.

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I have had serious heart rhythm problems in the last 6 months.

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I cannot lie on my back for an hour.

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I have had blood clots in my lungs before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and day of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood Pressure

Heart Rate

Other Symptoms

+2 more

Secondary study objectives

Cardiac Segment Visualization

Left Ventricular Opacification (LVO)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MVT-100Experimental Treatment2 Interventions

Each subject receives 100 uL x 2, 200 uL x 3, 300 uL x 2 or 1 vial of MVT-100 diluted in 50 mL of NS as follows: Two milliliter bolus over 10 seconds prior to each infusion rate;, then infusions will run for 5 minutes at 60 mL per hour, 5 minutes at 90 mL per hour, 5 minutes at 100 mL per hour and 5 minutes at 120 mL per hour.

Group II: DefinityActive Control2 Interventions

Each subject receives 100 uL x 2, 200 uL x 3, 300 uL x 2 or 1 vial of DEFINITY® 100 diluted in 50 mL of NS as follows: Two milliliter bolus over 10 seconds prior to each infusion rate;, then infusions will run for 5 minutes at 60 mL per hour, 5 minutes at 90 mL per hour, 5 minutes at 100 mL per hour and 5 minutes at 120 mL per hour.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Echocardiogram

2016

Completed Phase 2

~1910

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ultrasound contrast agents like MVT-100 and Definity improve echocardiogram quality by enhancing the delineation of the left ventricular endocardial border, which is essential for accurate diagnosis and management of heart disease. This precise imaging allows for better assessment of cardiac function and structure, leading to more effective treatment plans. Other common treatments for heart disease include ACE inhibitors, beta-blockers, and statins, which lower blood pressure, reduce heart workload, and manage cholesterol levels, respectively. These treatments help prevent complications such as heart attacks and strokes, thereby improving patient outcomes.

A Systematic Review and Meta-Analysis of the Efficacy and Safety of Xinbao Pill in Chronic Heart Failure.Effects of adaptive servo-ventilation therapy on cardiac function and remodeling in patients with chronic heart failure (SAVIOR-C): study protocol for a randomized controlled trial.Use of pharmaceuticals in noninvasive cardiovascular diagnosis.