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Diagnostic Test

Nuclear Imaging for Cardiomyopathy (DISSOLvE Trial)

Phase 3
Recruiting
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who were screened and eligible to be enrolled or have been already enrolled in the CARDIO-TTRansform randomized clinical trial (NCT04136171) and have a baseline 99m-technetium pyrophosphate planar and SPECT imaging done within 12 months prior to screening for CARDIO-TTRansform.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120-140 weeks
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the effects of two different treatments on heart function in people with amyloidosis.

Who is the study for?
This trial is for patients with Transthyretin Amyloid Cardiomyopathy or related heart conditions who are already part of the CARDIO-TTRansform study. They must be willing to consent and undergo additional imaging tests, and have had a specific heart scan within the last year.
What is being tested?
The study is testing how well a tracer called 99m-technetium pyrophosphate shows up in heart scans over time. This will help understand changes in patients' hearts during the CARDIO-TTRansform clinical trial.
What are the potential side effects?
Since this trial involves imaging procedures, side effects may include discomfort at injection site, allergic reactions to the tracer, or rare radiation exposure risks associated with nuclear imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was eligible for or enrolled in the CARDIO-TTRansform study and had specific heart scans within the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120-140 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120-140 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Secondary study objectives

Awards & Highlights

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: Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansformExperimental Treatment1 Intervention
Patients will undergo serial Tc-99m PYP imaging at baseline, week 61 and end of trial

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,008 Previous Clinical Trials
7,414,109 Total Patients Enrolled
2 Trials studying Amyloidosis
54 Patients Enrolled for Amyloidosis
Ionis Pharmaceuticals, Inc.Industry Sponsor
150 Previous Clinical Trials
27,682 Total Patients Enrolled
10 Trials studying Amyloidosis
3,559 Patients Enrolled for Amyloidosis
Ahmad Masri, MD MSStudy ChairOregon Health and Science University

Media Library

99m-technetium pyrophosphate scintigraphy (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05259072 — Phase 3
Amyloidosis Research Study Groups: Patients with transthyretin amyloid cardiomyopathy enrolled in CARDIO-TTRansform
Amyloidosis Clinical Trial 2023: 99m-technetium pyrophosphate scintigraphy Highlights & Side Effects. Trial Name: NCT05259072 — Phase 3
99m-technetium pyrophosphate scintigraphy (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05259072 — Phase 3
~20 spots leftby Dec 2025
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