Health TrialsbyHealthPanel

Thailand ATTR-CM Registry

ConditionTransthyretin Amyloid Cardiomyopathy (ATTR-CM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorMahidol University

About this trial

The investigators of this registry aim to study the natural history, clinical presentation, characteristics, and imaging findings of patients diagnosed with ATTR amyloidosis in Thailand longitudinally. This will enable the investigators to study this disease in depth. With a better understanding, the investigators can aim to develop early screening programs for at-risk patients, raising awareness among non-cardiologists. As amyloid-specific therapies have now become available in Thailand, the findings of this registry can be helpful for epidemiological studies in Thailand.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age > 18 years.

Positive scintigraphy by 99mTC-DPD [99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid] or 99mTC-PYP [Pyrophosphate] or 99mTC-HMDP [hydroxymethylene diphosphate] with Perugini grade ≥ 2 and/or H/CL (heart to contralateral lung) ratio > 1.5

Positive scintigraphy by 99mTC-DPD [99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid] or 99mTC-PYP [Pyrophosphate] or 99mTC-HMDP [hydroxymethylene diphosphate] with Perugini grade 1 and positive cardiac biopsy tissue confirmed which Congo red stain ≥ 4 sites

Positive scintigraphy by 99mTC-DPD [99mTC-3,3-diphosphono-1,2-propano-dicarboxylic acid] or 99mTC-PYP [Pyrophosphate] or 99mTC-HMDP [hydroxymethylene diphosphate] with Perugini grade 1 with positive non-cardiac biopsy tissue confirmed by Congo red stain

Disqualifiers

Diagnosed with amyloidosis caused by proteins other than transthyretin (light chain Amyloidosis, etc.)

Diagnosed with secondary amyloidosis

Trial population

All patients diagnosed with ATTR-CM,Transthyretin cardiomyopathy, who have either symptomatic or asymptomatic.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • No intervention

    Other intervention

    No intervention

Treatment groups

105 Participants
are divided into 1 treatment group
Group A: ATTR Cardiomyopathy1 intervention

Trial outcomes

Primary outcomes

1

Rate of death

Time frame
3 years
2

Rate of heart failure hospitalization

Time frame
3 years

Secondary outcomes

1

Transthyretin (ATTR) amyloidosis medication

Rate of use and rate of adverse effect of Transthyretin (ATTR) amyloidosis medication

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mahidol University

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov
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