Observing the natural course of transthyretin amyloidosis
A Non-interventional, Prospective, Multi-country Study Collecting Real-world Data on the Characteristics, Treatment Patterns, and Outcomes of Patients With Transthyretin (ATTR) Amyloidosis
AstraZeneca · NCT06465810
This study is looking to see how transthyretin amyloidosis progresses over time in over 1,600 adults while also gathering information on how well treatments like eplontersen work.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1850 (estimated) |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Sponsor | AstraZeneca (industry) |
| Locations | 60 sites (La Jolla, California and 59 other locations) |
| Trial ID | NCT06465810 on ClinicalTrials.gov |
What this trial studies
The MaesTTRo study is an international, longitudinal, non-interventional study that aims to enroll over 1,600 adult patients diagnosed with transthyretin (ATTR) amyloidosis. The study will collect primary data through patient-reported outcome questionnaires and secondary data from routine clinical practices to observe the disease's natural progression and treatment patterns. Patients will be followed for a minimum of 3 years, with data collected during routine visits, ensuring minimal disruption to their care. The study also aims to gather information on the effectiveness of treatments like eplontersen, a gene silencing therapy targeting TTR proteins.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of ATTR amyloidosis who can provide informed consent.
Not a fit: Patients with primary or light chain amyloidosis, asymptomatic ATTR mutation carriers, or those participating in interventional trials for ATTR amyloidosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the natural history of ATTR amyloidosis and improve treatment strategies for patients.
How similar studies have performed: While this study employs a novel observational approach, similar studies have shown success in understanding the natural history of other amyloidosis types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient willing and able to provide written informed consent to participate in the study * Confirmed diagnosis of amyloid transthyretin (ATTR) amyloidosis * Aged ≥18 years at the time of signing the informed consent * Patient willing and able to participate in collection of electronic patient reported outcomes (PROs) Exclusion Criteria: * Concurrent participation in any interventional trial for ATTR amyloidosis * Involvement in the planning and/or conduct of the current study * Patients with evidence of primary or light chain amyloidosis (AL) or serum protein A amyloidosis (AA) * Asymptomatic patients with ATTR amyloidosis and asymptomatic ATTR mutation carriers
Where this trial is running
La Jolla, California and 59 other locations
- Research Site — La Jolla, California, United States (RECRUITING)
- Research Site — Los Angeles, California, United States (RECRUITING)
- Research Site — San Francisco, California, United States (RECRUITING)
- Research Site — San Francisco, California, United States (RECRUITING)
- Research Site — New Haven, Connecticut, United States (RECRUITING)
- Research Site — Washington D.C., District of Columbia, United States (RECRUITING)
- Research Site — Chicago, Illinois, United States (RECRUITING)
- Research Site — Indianapolis, Indiana, United States (RECRUITING)
- Research Site — Boston, Massachusetts, United States (RECRUITING)
- Research Site — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- Research Site — Boston, Massachusetts, United States (RECRUITING)
- Research Site — Rochester, Minnesota, United States (RECRUITING)
- Research Site — Kansas City, Missouri, United States (RECRUITING)
- Research Site — St Louis, Missouri, United States (RECRUITING)
- Research Site — New Brunswick, New Jersey, United States (RECRUITING)
- Research Site — Manhasset, New York, United States (RECRUITING)
- Research Site — New York, New York, United States (RECRUITING)
- Research Site — New York, New York, United States (RECRUITING)
- Research Site — Durham, North Carolina, United States (RECRUITING)
- Research Site — Danville, Pennsylvania, United States (RECRUITING)
- Research Site — Philadelphia, Pennsylvania, United States (RECRUITING)
- Research Site — Philadelphia, Pennsylvania, United States (RECRUITING)
- Research Site — Greenville, South Carolina, United States (RECRUITING)
- Research Site — Germantown, Tennessee, United States (RECRUITING)
- Research Site — Nashville, Tennessee, United States (RECRUITING)
- Research Site — Dallas, Texas, United States (RECRUITING)
- Research Site — Richmond, Virginia, United States (RECRUITING)
- Research Site — Seattle, Washington, United States (RECRUITING)
- Research Site — Milwaukee, Wisconsin, United States (RECRUITING)
- Research Site — Vancouver, British Columbia, Canada (RECRUITING)
- Research Site — Vancouver, British Columbia, Canada (RECRUITING)
- Research Site — Halifax, Nova Scotia, Canada (RECRUITING)
- Research Site — London, Ontario, Canada (RECRUITING)
- Research Site — Toronto, Ontario, Canada (RECRUITING)
- Research Site — Rimouski, Quebec, Canada (NOT_YET_RECRUITING)
- Research Site — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
- Research Site — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
- Research Site — Beijing, Beijing Municipality, China (RECRUITING)
- Research Site — Changsha, Hunan, China (NOT_YET_RECRUITING)
- Research Site — Shanghai, Shanghai Municipality, China (RECRUITING)
- Research Site — Hebei Sheng, Shijiazhuang, China (NOT_YET_RECRUITING)
- Research Site — Shaanxi, Xi'An, China (RECRUITING)
- Research Site — Würzburg, Bavaria, Germany (NOT_YET_RECRUITING)
- Research Site — Frankfurt am Main, Hesse, Germany (RECRUITING)
- Research Site — Hanover, Lower Saxony, Germany (RECRUITING)
- Research Site — Aachen, North Rhine-Westphalia, Germany (RECRUITING)
- Research Site — Cologne, North Rhine-Westphalia, Germany (RECRUITING)
- Research Site — Mainz, Rhineland-Palatinate, Germany (RECRUITING)
- Research Site — Homburg, Saarland, Germany (RECRUITING)
- Research Site — Berlin, Germany (RECRUITING)
+10 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Transthyretin Amyloidosis, ATTR-CM, ATTRv-PN, ATTR, ATTR-Mixed, hATTR, Amyloidosis, Transthyretin