Exercise Effect on Transthyretin Stability

Athlete Heart Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986826
• Other study ID #: 00023050
• Status: Recruiting
• Start date: July 15, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2021
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 30, 2021
• Est. primary completion date: November 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amyloidosis
• Amyloidosis Transthyretin

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

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