Exercise Effect on Transthyretin Stability

NCT04986826 | Unknown

• 1 other identifier: 00023050
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amyloidosis Transthyretin; Athlete Heart

Keywords

exercise; amyloidosis

Outcome Measures

Primary Outcomes (1)

• Change in percent transthyretin stability assay

  Transthyretin stability will be measured and expressed as a percentage

  Change from baseline to 72 hours post-exercise

Secondary Outcomes (2)

• Plasma transthyretin level

  Change from baseline to 72 hours post-exercise

• Plasma transthyretin fragments

  Change from baseline to 72 hours post-exercise

Study Arms (3)

Healthy master athletes

Genotype positive phenotype negative transthyretin amyloidosis

Phenotype positive transthyretin amyloidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Motor Activity; Amyloidosis

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteostasis Deficiencies; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 3, 2021
• Study Start: July 15, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 30, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)