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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
UTICA 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.Check my eligibility
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.See study design
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.
UTICA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
UTICA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diastolic Function
Myocardial Blood Flow
Systolic Function
UTICA 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
1,618 Previous Clinical Trials
11,471,640 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have atrial fibrillation and am not taking blood thinners.I have been diagnosed with blocked heart arteries.A blood clot inside the heart has been confirmed by a doctor.I have severe heart failure that isn't controlled by medication.I have severe high blood pressure in the lungs.My blood pressure and heart rate are stable.You have conditions that make it unsafe for you to have a cardiac magnetic resonance imaging (CMR) scan.I am not allergic to DEFINITY or its components.I am over 18 for AL-CA, over 65 for ATTR-CA, or over 65 as a control.You weigh more than is healthy for your height.I experience severe claustrophobia even with sedatives.I have a heart condition that is neither due to blocked arteries nor amyloid buildup.You are pregnant.I have had a stroke before.I have severe lung disease.You have a long QT interval on an electrocardiogram.I have had heart surgery before.I have a severe heart valve problem.Abnormal movement of the heart's walls on an echocardiogram.Your heart's pumping ability is less than 40%.My heart is affected by AL amyloidosis, confirmed by tests or scans.You have serious problems with your body's salt and mineral levels.I cannot undergo sonotherapy due to health reasons.The doctor thinks you are not a good fit for ultrasound treatment for reasons not listed here.I have systemic light chain amyloidosis and am in remission.I have been diagnosed with heart amyloidosis.
Research Study Groups:
This trial has the following groups:- Group 1: Sonotherapy
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks are posed by Sonotherapy treatments?
"Sonotherapy is considered to have a high safety rating of 3, as it has passed Phase 4 clinical trials and been approved."
Answered by AI
Are older adults excluded from this research protocol?
"The requirements for the trial set a lower limit at 18 years old and an upper boundary of 90. There is also 1 study available specifically for children under 18, as well as 104 trials catering to elderly patients over 65."
Answered by AI
Are there still openings for this research endeavor?
"Affirmative. The details posted on clinicaltrials.gov demonstrate that this trial, initially listed on April 15th 2023, is presently seeking participants. Approximately 70 patients need to be enrolled from one medical centre."
Answered by AI
Who is the ideal demographic for participation in this research?
"In order to take part in this clinical trial, applicants must have cardiac amyloidosis and be between 18 and 90 years old. At the moment, 70 people are being recruited for the study."
Answered by AI
What is the current participation rate of this medical experiment?
"Affirmative. The clinicaltrial.gov platform verifies that this medical trial, initially published on April 15th 2023, is actively seeking participants. 70 patients must be enlisted from 1 research centre."
Answered by AI
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