Exercise Effect on Transthyretin Stability

Study Overview
=================
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.

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

Conditions
-----------------
Athlete Heart, Amyloidosis Transthyretin

Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy master athletes<br> | |
| Genotype positive phenotype negative transthyretin amyloidosis<br> | |
| Phenotype positive transthyretin amyloidosis<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
exercise, amyloidosis