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Amyloidosis TTR Flow Reserve Evaluation

Study acronym: AMYTRE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Study sites: 3 to 4
    • Primary completion date: Nov 2026 to Dec 11, 2026
    • Study completion date: Dec 2026 to Dec 11, 2026
    v9
  2. Notable Primary completion date: Feb 2026 to Nov 2026v8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Feb 2026 to Dec 2026
    • Study description expanded, about 148 words
    • Site details revised at 3 of 3 sites
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Minor Site details revised at 2 of 3 sitesv6
  5. Minor Study sites revised (3)v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Mar 2026 to Feb 2026
    • Start date changed from estimate of Mar 2022 to Feb 24, 2022
    • Site details revised at 3 of 3 sites
    v4
  2. Notable Start date: Dec 2021 to Mar 2022
    • Primary and study completion dates: Dec 2025 to Mar 2026
    v3
  3. Minor Eligibility criteria expanded, about 1 wordv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05103943
Lead Sponsor Centre Hospitalier Régional d'Orléans
Conditions
(from sponsor)
Amyloid Cardiomyopathy
Related terms Amyloid Neuropathies, Familial
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov