Exercise Effect on Transthyretin Stability

• Conditions: Amyloidosis Transthyretin; Athlete Heart

• Registration Number: NCT04986826
• Lead Sponsor: Oregon Health and Science University

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.

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.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-15
• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-22
• Last Update Submitted: 2021-07-22
• Study First Posted: 2021-08-03
• Last Update Posted: 2021-08-03
• Primary Completion: 2021-11-30
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in percent transthyretin stability assay	Change from baseline to 72 hours post-exercise	Transthyretin stability will be measured and expressed as a percentage

Secondary Outcome Measures

Name	Time	Method
Plasma transthyretin fragments	Change from baseline to 72 hours post-exercise	Plasma transthyretin fragments will be measured
Plasma transthyretin level	Change from baseline to 72 hours post-exercise	Plasma transthyretin level will be measured

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States