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Status unknownNCT04986826Updated Aug 3, 2021

Exercise Effect on Transthyretin Stability

An observational study in Amyloidosis Transthyretin and Athlete Heart, sponsored by Oregon Health and Science University. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-03.

Sponsored by Oregon Health and Science University · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
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Study summary

The goal of this study to investigate if exercise predisposes to transthyretin instability. The investigators will evaluate the effect of exercise on transthyretin biochemistry.

Read the detailed description

This is an investigator initiated observational study, designed to study the effect of exercise on transthyretin stability in three main populations: Group 1: healthy master athletes who are 60 years or older. Group 2: Genotype positive (G+) cardiac phenotype negative (P-) patients with variant ATTR (i.e. carriers without evidence of disease). Group 3: Patients with ATTR CA who have not been on a stabilizer (tafamidis) within the last 14 days prior to enrollment.

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Conditions studied

  • Amyloidosis Transthyretin
  • Athlete Heart

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Keywords

  • exercise
  • amyloidosis
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In context

Amyloidosis

491 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.

This study's planned enrollment of 24 is below the median of 141 across 156 observational studies indexed under Amyloidosis.

Browse Amyloidosis studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Master athletes without evidence of transthyretin amyloidosis. Genotype positive phenotype negative transthyretin amyloidosis, and phenotype positive transthyretin amyloidosis.

Inclusion criteria

General inclusion criteria: patients should be able to exercise on a treadmill or a bike, willing to consent to the study procedures and willing to return to site during the follow up period of 72 hours for repeated blood and urine collection

Specific inclusion criteria:

  • Group 1: Subjects must be at least 60 years of age and meet the master athlete definition of: athletes engaged in cycling ≥8 hours per week or running ≥6 hours per week or triathlon training (combination of swimming, cycling, running) ≥8 hours per week, or equivalent sports activities, for at least 6 months prior to enrollment.
  • Group 2: Genotype positive (G+) cardiac phenotype negative (P-) patients with variant ATTR (i.e. carriers without evidence of disease)
  • Group 3: Patients with ATTR CA who have not been on a stabilizer (tafamidis) within the last 14 days prior to enrollment.

Exclusion criteria

Exclusion Criteria:

Taking diflunisal or daily non-steroidal anti-inflammatory drugs (NSAIDs) use within 2 weeks.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy master athletes
  • Genotype positive phenotype negative transthyretin amyloidosis
  • Phenotype positive transthyretin amyloidosis
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What researchers measure

Primary outcomes

  1. Change in percent transthyretin stability assay

    Transthyretin stability will be measured and expressed as a percentage

    Time frame: Change from baseline to 72 hours post-exercise

Secondary outcomes

  1. Plasma transthyretin level

    Plasma transthyretin level will be measured

    Time frame: Change from baseline to 72 hours post-exercise

  2. Plasma transthyretin fragments

    Plasma transthyretin fragments will be measured

    Time frame: Change from baseline to 72 hours post-exercise

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Study locations

1 of 1 sites recruiting
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
    • Ahmad Masri, MD · Contact · masria@ohsu.edu · 503-494-8582
    • Ahmad Masri, MD · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04986826
Lead sponsor
Oregon Health and Science University
Responsible party
Ahmad Masri (Principal Investigator, Oregon Health and Science University) — Principal investigator
First posted
Aug 3, 2021
Start date
Jul 15, 2021
Primary completion
Nov 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Aug 3, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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