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New treatment option for Amyloidosis Transthyretin
Official title Quantitative Analysis of Myocardial Uptake of Bone Radiopharmaceuticals in Patients With Cardiac ATTR Amyloidosis
ClinicalTrials.gov ID: NCT04535349
What this study is testing
- What it's testing
- Introduction: Transthyretin cardiac amyloidosis (ATTR) is an important cause of heart failure. Cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is used as a noninvasive diagnostic criterion in patients without detectable monoclonal protein.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Medical history of Heart Failure (HF) with at least 1 prior hospitalization for HF or clinical evidence of HF (without hospitalization) manifested by...
- 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
You likely can't join if
- 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)
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France; Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.