NCT05103943Active, not recruiting
Amyloidosis TTR Flow Reserve Evaluation
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
Anginal symptoms and signs of ischemia have been reported in some patients with cardiac amyloidosis (TTR) without obstructive epicardial coronary artery disease (CAD). It was found that coronary microvascular dysfunction was highly prevalent in subjects with cardiac amyloidosis, even in the absence of epicardial CAD. The investigators found lower stress and rest myocardial blood flow (MBF) and lower myocardial flow reserve (MFR) in their cardiac PET (Positron emission tomography) study (13N), including 21 patients. The advances in SPECT technology including cadmium zinc telluride (CZT) detectors allow to evaluate the MBF and MFR estimation by SPECT as shown in both experimental animal models and also in clinical studies with comparison to PET. SPECT is more widely available than cardiac PET.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 30 Sept 2021
- Start date
- 24 Feb 2022
- Primary completion date
- 11 Dec 2026
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Diseases
- Amyloidosis
- NCT number
- NCT05103943
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 24 Feb 2022 to the primary completion date, 11 Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with tafamidis or patisaran;
- Previous CAD, severe epicardial stenosis with revascularization or ticagrelor treatment, coronary artery bypass grafting, myocardial infarction;
Other illness
- Heart failure not due to transthyretin amyloid cardiomyopathy;
- New York Heart Association (NYHA) class IV heart failure.
- A history of liver or heart transplantation;
Lab values
- Liver transaminase levels exceeding two times the upper limit of the normal range;
- Severe malnutrition as defined by a modified body-mass index (mBMI) of less than 600, calculated as the serum albumin level in grams per litter multiplied by the conventional BMI (the weight in kilograms divided by the square of the height in meters);
- Patients receiving concurrent treatment with nonsteroidal anti-inflammatory drugs, tauroursodeoxycholate, doxycycline, calcium-channel blockers, or digitalis;
Other
- The presence of light-chain amyloidosis;
- An estimated glomerular filtration rate lower than 25 mL per minute per 1.73 m2 of bodysurface area (Cockcroft).
- Ticagrelor treatment
- Contra-indications to pharmacological stress testing MPI: severe hypotension (\< 90 mmHg of Systolic arterial pressure), atrioventricular block 2nd or 3rd grade, carotid stenosis (unilateral \>70%, bilateral \>50%);
- Pregnancy
- Breastfeeding
- Protected adults
- Other study participation
Who the study is looking for
- Patients aged from 18 to 90 years
- Understanding and speaking French
- With TTR amyloid cardiomyopathy (ATTRxt or ATTRm) confirmed by the association of heart failure, syncope or bradyarrhythmia, with electrocardiogram and/or magnetic resonance imaging (CMR) suggesting/indicating cardiac amyloid, grade 2 or 3 99mTc- PYP or bone scintigraphy and negative biological findings (i.e. serum immunofixation, urine immunofixation, serum free light chain assay); or, if one of those criteria is not met, presence of amyloid deposits on analysis of biopsy specimens obtained from cardiac and non-cardiac sites (17-19),
- Intention to treat (Tafamidis)
Age in the registry: 18 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU d Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU Orléans Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| CHRU de Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.