Clinical trial Recruiting at 2 sites Interventional Ages 18 to 100

Analyzing Heart Uptake of Bone Medications in Patients with Cardiac Amyloidosis

Official title: Quantitative Analysis of Myocardial Uptake of 99mTclabeled Bone Radiopharmaceuticals Using New Whole-body CZT-based SPECT-CT Cameras, at Baseline and During Medical Treatment With Tafamidis in Patients With Cardiac Transthyretin Amyloidosis

Run by University Hospital, Caen · NCT04535349 · Data updated 2026-11-12

This study is testing how well certain bone medications are taken up by the heart in patients with cardiac amyloidosis to see if it can help improve their diagnosis and treatment.

More Transthyretin Amyloidosis trials

Quick facts

Study typeInterventional
Ages18 Years to 100 Years
SexAll
Enrollment35 (estimated)
SponsorUniversity Hospital, Caen
Academic / other
Locations2 sites (Caen and 1 other locations)
StatusRecruiting
StartedOctober 8, 2020
Main results expectedJune 15, 2027
Study endsJanuary 15, 2028
Registry record updatedNovember 9, 2026
Trial IDNCT04535349 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with a history of heart failure and suspected cardiac ATTR amyloidosis who meet specific clinical criteria.

Probably not a fit

Patients with primary amyloidosis or those with severe heart failure (NYHA class IV) may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the myocardial uptake of bone-seeking radiopharmaceuticals in patients diagnosed with cardiac transthyretin amyloidosis (ATTR). It aims to include 35 patients who have a suspected diagnosis of cardiac ATTR and will undergo cardiac planar radionuclide imaging as part of their routine care. The study focuses on developing quantitative methods for diagnosis, prognosis assessment, and evaluating therapeutic responses to treatments like tafamidis meglumine, which has shown promise in reducing mortality and hospitalizations. By utilizing advanced imaging techniques, the study seeks to enhance the understanding and management of this condition.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and prognostic tools for patients with cardiac ATTR amyloidosis.

How similar studies have gone: Other studies have shown success in using radionuclide imaging for similar conditions, indicating potential for this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by signs or symptoms of volume overload or elevated intracardiac pressures that required/requires treatment with a diuretic for improvement, and an increase of BNP \>200 pg/mL and/or NT-proBNP \>500 pg/mL
* Suspected cardiac ATTR amyloidosis
* Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness \> 12 mm
* Patient signed consent
* Contraception method

Exclusion Criteria:

* New York Heart Association (NYHA) functional class IV despite diuretic treatment
* Life expectancy \<6 month due to the severity of cardiac amyloidosis and/or comorbidities
* Aortic valve surgical or percutaneous replacement within 30 days or planned within months
* Presence of primary (light chain) amyloidosis
* Contraindication to tafamidis
* Pregnancy and breast feeding ; pregnancy test in women of reproductive age irrespective of contraception method)
* Adults with protective measures

Where it's running

  • CHU de Caen
    Caen, France
    Recruiting
  • Clinique du Bois
    Lille, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.