Quantitative Analysis of Myocardial Uptake of Bone Radiopharmaceuticals in Patients With Cardiac ATTR Amyloidosis

NCT04535349

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Amyloidosis Transthyretin
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-100 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Quantitative Analysis of Myocardial Uptake of Bone Radiopharmaceuticals in Patients With Cardiac ATTR Amyloidosis
Official Title  ICMJE 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
Brief Summary

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. The visual assessment remains the main noninvasive criterion for the diagnosis. Medical therapy using tafamidis meglumine that binds to transthyretin and prevents amyloidogenesis, recently demonstrated a reduction in all-cause mortality and cardiovascular-related hospitalizations. As a consequence, there is a need for quantitative approaches that would be useful for diagnosis and prognosis assessment but also for the evaluation of patient therapeutic response.

Materials and methods: The investigators aim to include 35 patients with a suspected diagnosis of cardiac ATTR amyloidosis in whom a cardiac planar radionuclide imaging using 99mTc-labeled bone seeking radiopharmaceuticals is planned as part of routine noninvasive diagnosis work-up. Using a test-retest approach, the aim is to compare a quantitative method vs. conventional semi-quantitative approaches for the assessment of cardiac uptake of bone radiopharmaceuticals using new 3D CZT-based SPECT-CT cameras in patients with suspected cardiac ATTR amyloidosis. The investigators estimated that 20 patients will have a diagnosis of cardiac ATTR amyloidosis. In the latter patients, the aim is to evaluate the impact of 6-month therapy using tafamidis on quantitative and semi-quantitative assessment of cardiac uptake of bone radiopharmaceuticals Perspectives: This new non invasive imaging techniques for the quantitative assessment of the amyloid burden in patients with cardiac ATTR amyloidosis may help identify the responders and the patients who should benefit from dose intensification.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Amyloidosis Transthyretin
Intervention  ICMJE Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT)
Quantitative analysis of myocardial uptake of 99mTc-labeled bone radiopharmaceuticals using new whole-body CZT-based SPECT-CT cameras
Study Arms  ICMJE
  • No cardiac ATTR amyloidosis

    Cardiac echocardiography at baseline and whole-body & CZT bone tracer imaging (SPECT).

    day 3 - day 10 : second whole-body & CZT bone tracer imaging (SPECT), test-retest Bone tracer imaging Perugini 0 : no cardiac TTR amyloidosis No further follow-up.

    Intervention: Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT)
  • Cardiac ATTR amyloidosis, no treatment with tafamidis planned

    Cardiac echocardiography at baseline and whole-body & CZT bone tracer imaging (SPECT).

    day 3 - day 10 : second whole-body & CZT bone tracer imaging (SPECT), test-retest Bone tracer imaging demonstrating cardiac ATTR amyloidosis but no treament with tafamidis planned.

    Cardiac echocardiography at 3 months and whole-body & CZT bone tracer SPECT and cardiac echocardiography at 6 months

    Intervention: Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT)
  • Cardiac ATTR amyloidosis, treatment with tafamidis planned

    Cardiac echocardiography at baseline and whole-body & CZT bone tracer imaging (SPECT).

    day 3 - day 10 : second whole-body & CZT bone tracer imaging (SPECT), test-retest Bone tracer imaging demonstrating cardiac ATTR amyloidosis. Start of the treament with tafamidis.

    Cardiac echocardiography at 3 months and whole-body & CZT bone tracer SPECT and cardiac echocardiography at 6 months

    Intervention: Diagnostic Test: Whole-body & CZT bone tracer imaging (SPECT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2020)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 15, 2022
Estimated Primary Completion Date September 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Damien Legallois, MD33230165709[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04535349
Other Study ID Numbers  ICMJE 19-226
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account University Hospital, Caen
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP