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Ultrasound Contrast Agents for Heart Imaging

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 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

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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,921 Previous Clinical Trials
47,760,606 Total Patients Enrolled
2 Trials studying Single Ventricle Heart Disease
500 Patients Enrolled for Single Ventricle Heart Disease
Microvascular Therapeutics, LLCLead Sponsor
1 Previous Clinical Trials
University of NebraskaOTHER
555 Previous Clinical Trials
1,145,348 Total Patients Enrolled

Media Library

MVT-100 Clinical Trial Eligibility Overview. Trial Name: NCT03882359 — Phase 1 & 2
Single Ventricle Heart Disease Research Study Groups: Definity, MVT-100
Single Ventricle Heart Disease Clinical Trial 2023: MVT-100 Highlights & Side Effects. Trial Name: NCT03882359 — Phase 1 & 2
MVT-100 2023 Treatment Timeline for Medical Study. Trial Name: NCT03882359 — Phase 1 & 2
Single Ventricle Heart Disease Patient Testimony for trial: Trial Name: NCT03882359 — Phase 1 & 2
~0 spots leftby Dec 2024