Clinical Trial: DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis
Brief Summary: The purpose of this study is to characterize the frequency of TTR mutations in subjects suspected of having cardiac amyloidosis
Detailed Summary:
Sponsor: Alnylam Pharmaceuticals
Current Primary Outcome: Proportion of patients with of Transthyretin (TTR) mutations [ Time Frame: Baseline ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Assessment of the presence of amyloid in tissue [ Time Frame: Day 30 ]An optional fine-needle aspirate of the abdominal fat pad will be collected
- Quantification of biomarkers of cardiac function in serum [ Time Frame: Day 30 ]Biomarkers that assess cardiac function will be quantified from serum
- Measurement of echocardiogram parameters [ Time Frame: Day 30 ]Cardiac structure and function will be measured by echocardiogram
- New York Heart Association (NYHA) Functional Classification [ Time Frame: Day 30 ]NYHA Functional Classification will be determined
- Results from 6-Minute Walk Test [ Time Frame: Day 30 ]Total distance walked in 6 minutes will be measured
Original Secondary Outcome: Same as current
Information By: Alnylam Pharmaceuticals
Dates:
Date Received: September 22, 2014
Date Started: June 2014
Date Completion:
Last Updated: July 19, 2016
Last Verified: July 2016