Recruiting

Exercise

Sponsor:

Oregon Health and Science University

Code:

NCT04986826

Conditions

Amyloidosis Transthyretin

Athlete Heart

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT04986826

Start date

Jul 15, 2021

Status verified date

Jul, 2021

Completion date

Dec 30, 2021

Anticipated

Primary completion date

Nov 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy master athletes

Genotype positive phenotype negative transthyretin amyloidosis

Phenotype positive transthyretin amyloidosis

Primary outcome measure

  • Change in percent transthyretin stability assay [ Time Frame: Change from baseline to 72 hours post-exercise ]

Central Contacts and Locations

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Ahmad Masri, MD

503-494-8582masria@ohsu.edu

Principal Investigator:

Ahmad Masri, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Aug 3, 2021

Last verified

Jul, 2021

Keywords

  • exercise
  • amyloidosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2021-08-03.