Quantitative-imaging in Cardiac Transthyretin Amyloidosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-25

Study Completion Date

2026-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Transthyretin amyloid cardiomyopathy (ATTR-CM), is a heart muscle disease that's stops the heart muscle working properly. With an ageing population, it is increasingly common but untreated, it has a poor prognosis. Several novel expensive treatments have become available, although we do not understand exactly how they work and why some patients respond, and others do not. The challenge is to develop better methods for monitoring the effects of these treatments, maximizing their benefits and cost-effectiveness. In I-CARE we aim to bring a new imaging technique, named 18F-fluoride PET, to the clinic and thereby improve the care of patients with ATTR-CM.

Hypotheses:

1. A delayed imaging protocol and state-of-the-art PET motion correction will optimise 18F-fluoride imaging in ATTR-CM and provide a clear threshold in myocardial TBR values for the diagnosis of ATTR-CM.
2. Optimised 18F-fluoride PET will provide a quantitative marker of the ATTR-CM burden that will allow disease progression and treatment response to be tracked.
3. Myocardial 18F-fluoride TBR values will reduce in patients responding to tafamidis treatment and increase in non-responders and patients not receiving therapy

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PET/MR Imaging In Patients With Cardiac Amyloidosis

NCT03626584

Cardiac Amyloidosis

COMPLETED

CARDIO-TTRansform Magnetic Resonance Imaging (MRI) Sub-study

NCT06073574

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

ACTIVE_NOT_RECRUITING

Test-retest Study With [18F]FBB in Cardiac Amyloidosis

NCT06790394

Cardiac Amyloidosis

RECRUITING PHASE1

Cardiac Amyloid Deposits and Heart Dysfunction in Alzheimer's Disease

NCT07154394

Dementia, Alzheimer Type Mild Cognitive Impairment Cardiac Amyloidosis

RECRUITING

Detection and Significance of Heart Injury in ST Elevation Myocardial Infarction.

NCT02072850

Acute ST-elevation Myocardial Infarction

ACTIVE_NOT_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Studies have shown that there is calcium deposition in the heart muscle in ATTR-CM but exactly how this happens is not completely understood. Tafamidis, a new drug treatment, has shown improved outcomes for patients with ATTRCM by reducing hospitalisations and improving survival but the mechanism of action of Tafamidis is also not clearly understood yet. 18F-Fluoride PET/CT offers the opportunity to study this phenomenon of calcium deposition in ATTR-CM in more detail and study and track response to the new drug treatment. This will also provide an opportunity to investigate whether tafamidis therapy reduces calcium deposition in the heart muscle associated with ATTR-CM.

We have designed the study specifically to answer our research questions as best as possible, whilst keeping burdens to the patients at a minimum.

To the best of our knowledge this will be the first human study to utilise this imaging technique to assess and track response to the new drug treatment in ATTR-CM. We hope that it will provide major insights in to complex interactions at play, that could drive forward the development of novel therapeutic strategies for patients with ATTR-CM.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ATTR-CM

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Work package 1 - Optimisation of 18F-fluoride PET in ATTR-CM

Optimise 18F-fluoride PET imaging of ATTR-CM with increased myocardial tissue to background ratio (TBR) uptake values to provide a state-of-the-art imaging modality for use in the other work packages. (n=15, ATTR-CM subjects)