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Ultrasound Therapy In Cardiac Amyloidosis

Study acronym: UTICA
StatusRecruiting
PhasePhase 4
Started2023-08-31
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Apr 30, 2026 → Apr 30, 2027
See other at-risk trials from Brigham and Women's Hospital

Amendment history

2026-08-20
Study Status v13
Primary completion pushed: 2026-04-30 → 2027-04-30
2025-11-13
Study Status v12
Re-verified, no change to tracked fields
2024-03-05
Study Status, Eligibility v11
Primary completion date2025-06-30→2026-04-30
Completion date2025-06-30→2027-04-30
Eligibility criteria-167 characters
[...] egnant state Documented allergy to N-13 ammonia or Definity Contraindications to CMR Implantable Cardioverter Defibrillator (ICD) Significant renal dysfunction with estimated glomerular filtration rate < 30 ml/min/m2. Dialysis Contraindications to DEFINITY® (Perflutren Lipid Microsphere [...]
2023-12-01
Study Status, Study Description, Outcome Measures v10
Start date2023-04-15→2023-08-31
Study description+15 characters
[...] cts 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.
2023-07-25
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v9
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
Show 8 earlier versions
2023-03-02
Study Status v8
Start date2022-12-01→2023-04-15
2022-10-23
Study Status v7
Start date2022-09-15→2022-12-01
2022-07-18
Study Status v6
Start date2022-06-15→2022-09-15
2022-05-09
Study Status, Contacts/Locations v5
Start date2022-01-05→2022-06-15
2022-01-03
Study Status v4
Start date2021-10-15→2022-01-05
2021-09-16
Study Status, Sponsor/Collaborators v3
Start date2021-04-15→2021-10-15
2021-03-22
Study Status, Eligibility, Contacts/Locations v2
Primary completion date2023-06-30→2025-06-30
Completion date2023-06-30→2025-06-30
Start date2021-01-01→2021-04-15
2020-12-11
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2020-12-08
Original filing
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.
Trial Details
NCT Number NCT04667494
Lead Sponsor Brigham and Women's Hospital
Conditions Amyloidosis Cardiac
Enrollment 70 participants
Start Date 2023-08-31
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-21