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Procedure

Ultrasound Therapy for Cardiac Amyloidosis (UTICA Trial)

Phase 4
Recruiting
Led By Sharmila Dorbala, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Proof of cardiac involvement by AL amyloidosis with abnormal cardiac biomarkers or imaging
Diagnosis of systemic light chain amyloidosis by standard criteria and in hematological remission
Must not have
Atrial fibrillation not on anticoagulation
Known obstructive epicardial coronary artery disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial studies the effects of soundwaves on hearts with or without a rare heart condition.

Who is the study for?
This trial is for adults over 18 with AL cardiac amyloidosis in remission, or those over 65 with ATTR cardiac amyloidosis or as controls. Participants must have proof of heart involvement and be able to consent. Excluded are pregnant individuals, those with other heart diseases, severe heart failure, allergies to specific ultrasound contrast agents, low ejection fraction (<40%), pulmonary hypertension, history of stroke, extreme claustrophobia, severe lung disease or valve issues.
What is being tested?
The study tests sonotherapy's effects on blood flow and heart function in patients with cardiac amyloidosis compared to control subjects without the condition. It's a forward-looking pilot study where participants undergo sonotherapy treatment and then have their myocardial blood flow and heart functions assessed before and after the therapy.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects from sonotherapy may include discomfort at the site of application or temporary changes in local sensation due to ultrasound energy exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart is affected by AL amyloidosis, confirmed by tests or scans.
Select...
I have systemic light chain amyloidosis and am in remission.
Select...
I have been diagnosed with heart amyloidosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have atrial fibrillation and am not taking blood thinners.
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I have been diagnosed with blocked heart arteries.
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I have severe heart failure that isn't controlled by medication.
Select...
I have severe high blood pressure in the lungs.
Select...
My blood pressure and heart rate are stable.
Select...
I am not allergic to DEFINITY or its components.
Select...
I experience severe claustrophobia even with sedatives.
Select...
I have a heart condition that is neither due to blocked arteries nor amyloid buildup.
Select...
I have had a stroke before.
Select...
I have severe lung disease.
Select...
I have had heart surgery before.
Select...
I have a severe heart valve problem.
Select...
I cannot undergo sonotherapy due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diastolic Function
Myocardial Blood Flow
Systolic Function

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SonotherapyExperimental Treatment1 Intervention
All participants will undergo sonotherapy

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,554 Total Patients Enrolled
2 Trials studying Cardiac Amyloidosis
88 Patients Enrolled for Cardiac Amyloidosis
Sharmila Dorbala, MDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
236 Total Patients Enrolled
1 Trials studying Cardiac Amyloidosis
65 Patients Enrolled for Cardiac Amyloidosis

Media Library

Sonotherapy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04667494 — Phase 4
Cardiac Amyloidosis Research Study Groups: Sonotherapy
Cardiac Amyloidosis Clinical Trial 2023: Sonotherapy Highlights & Side Effects. Trial Name: NCT04667494 — Phase 4
Sonotherapy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04667494 — Phase 4
~38 spots leftby Apr 2026
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