NCT04667494

Ultrasound Therapy In Cardiac Amyloidosis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This is a prospective pilot clinical study of subjects with cardiac amyloidosis and control subjects without amyloidosis where we plan to evaluate changes in myocardial blood flow, systolic and diastolic function before and after sonotherapy.

Detailed description

70 subjects will be enrolled in this study in 3 study groups: A) 30 subjects with light chain cardiac amyloidosis B) 30 subjects with transthyretin cardiac amyloidosis and C) 10 subjects without amyloidosis. All subjects will undergo rest 2D echocardiography, rest N-13 ammonia or rubidium-82 perfusion PET, Definity infusion with high mechanical index (MI) imaging defined as sonotherapy in this study protocol.

Conditions

• Amyloidosis Cardiac

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Sonotherapy	Use of high mechanical index ultrasound therapy with intravenous Definity contrast infusion

Timeline

• Start date: 2023-08-31
• Primary completion: 2026-04-30
• Completion: 2027-04-30
• First posted: 2020-12-14
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study