Exercise Effect on Transthyretin Stability

Exercise Effect on Transthyretin Stability in Master Athletes and Patients With Transthyretin Amyloidosis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04986826

Enrollment

Registered

2021-08-03

Start date

2021-07-15

Completion date

2021-12-30

Last updated

2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloidosis Transthyretin, Athlete Heart

Keywords

exercise, amyloidosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Plasma transthyretin level	Change from baseline to 72 hours post-exercise	Plasma transthyretin level will be measured
Plasma transthyretin fragments	Change from baseline to 72 hours post-exercise	Plasma transthyretin fragments will be measured

Countries

United States

Outcome results