Exercise Effect on Transthyretin Stability

NCT ID: NCT04986826

Last Updated: 2021-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-15

Study Completion Date

2021-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Amyloidosis Transthyretin Athlete Heart

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy master athletes

No interventions assigned to this group

Genotype positive phenotype negative transthyretin amyloidosis

No interventions assigned to this group

Phenotype positive transthyretin amyloidosis

No interventions assigned to this group

Eligibility Criteria

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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

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Masri

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Ahmad Masri, MD

Role: primary

503-494-8582

Other Identifiers

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00023050

Identifier Type: -

Identifier Source: org_study_id

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