Using advanced imaging to improve treatment for heart disease caused by amyloidosis
Quantitative-imaging in Cardiac Transthyretin Amyloidosis
This study is testing a new imaging technique to see if it can help doctors better understand and treat heart disease caused by amyloidosis in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT05776212 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on transthyretin amyloid cardiomyopathy (ATTR-CM), a heart condition that affects the heart muscle's function. It aims to utilize a novel imaging technique, 18F-fluoride PET, to better understand calcium deposition in the heart and how it relates to the effectiveness of the drug tafamidis. By optimizing imaging protocols, the study seeks to establish clear diagnostic thresholds and track disease progression in patients with ATTR-CM. The findings could lead to improved monitoring and treatment strategies for this condition.
Who should consider this trial
Good fit: Ideal candidates include adults over 40 with ATTR or AL cardiac amyloidosis, or over 30 with hypertrophic cardiomyopathy.
Not a fit: Patients with severe renal dysfunction, advanced heart failure, or contraindications to the study's imaging techniques or tafamidis therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding and management of ATTR-CM, leading to better patient outcomes and more effective treatments.
How similar studies have performed: This approach is novel and has not been previously tested in human studies for tracking response to tafamidis in ATTR-CM.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Completion of informed consent * Age \> 40 years for patients with ATTR or AL cardiac amyloidosis and age \>30 years for patients with HCM * ATTR cardiac amyloid according to Expert Consensus Recommendations * AL amyloidosis according to Expert Consensus Recommendations * Hypertrophic cardiomyopathy according to European Society of Cardiology guidelines Exclusion Criteria: * Inability or unwilling to give informed consent * Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial. * Renal dysfunction (eGFR ≤30 mL/min/1.73m2) * NYHA Class IV heart failure * Patients with atrial fibrillation and poor rate control. * Contraindications to MR * Previous history of contrast allergy of adverse reactions (gadolinium) * Contraindications to tafamidis therapy
Where this trial is running
Groningen
- University Medical Centre Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marc Dweck, MD PhD — Centre of Cardiovascular Science
- Study coordinator: Riemer Slart, MD PhD
- Email: r.h.j.a.slart@umcg.nl
- Phone: +31503611835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.