Amyloidosis TTR Flow Reserve Evaluation

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Brief Title

Amyloidosis TTR Flow Reserve Evaluation

Official Title

Amyloidosis TTR Flow Reserve Evaluation

Brief Summary

      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. Thus, the investigators would like:

        1. to confirm the results of Dorbala et al using SPECT, and

        2. to go further with evaluation of the effect of Tafamidis on microvascular dysfunction.
    



Study Type

Interventional


Primary Outcome

Difference of Stress and Rest Myocardial Blood Flow

Secondary Outcome

 Number or participants with stress reduction

Condition

Amyloid Cardiomyopathy

Intervention

SPECT MPI

Study Arms / Comparison Groups

 SPECT MPI (myocardial perfusion imaging) Group
Description:  the SPECT MPI protocol will be modified to evaluated MBF and MFR. This modification will result in no added radiation; the radiopharmaceutical dose will still be the same compared to a standard MPI protocol.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

50

Start Date

February 24, 2022

Completion Date

February 2026

Primary Completion Date

February 2026

Eligibility Criteria

        Inclusion Criteria:

          -  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)

        Exclusion Criteria:

          -  Heart failure not due to transthyretin amyloid cardiomyopathy;

          -  New York Heart Association (NYHA) class IV heart failure.

          -  The presence of light-chain amyloidosis;

          -  A history of liver or heart transplantation;

          -  An estimated glomerular filtration rate lower than 25 mL per minute per 1.73 m2 of
             bodysurface area (Cockcroft).

          -  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;

          -  Previous treatment with tafamidis or patisaran;

          -  Ticagrelor treatment

          -  Previous CAD, severe epicardial stenosis with revascularization or ticagrelor
             treatment, coronary artery bypass grafting, myocardial infarction;

          -  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
      

Gender

All

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Matthieu BAILLY, Dr, +33238744071, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT05103943

Organization ID

CHRO-2021-05


Responsible Party

Sponsor

Study Sponsor

Centre Hospitalier Régional d'Orléans


Study Sponsor

Matthieu BAILLY, Dr, Principal Investigator, CHR d'ORLEANS


Verification Date

June 2022