Researchers will enroll patients with heart failure with preserved ejection fraction (HFpEF) who are 65 years of age and older to evaluate how frequently transthyretin (ATTR) amyloidosis occurs in this group of patients.
Studies indicate that transthyretin amyloidosis can sometimes cause HFpEF, which is a condition in which heart failure occurs but the pumping function of the heart is preserved. Researchers want to understand how frequently transthyretin amyloidosis occurs in this cohort of patients and investigate if it is possible to predict which patients with heart failure may have the condition.
“Our goal is to identify amyloidosis in heart failure patients earlier so that they can start treatment,” Hanna Kim Gaggin, of Massachusetts General Hospital in Boston, wrote.
This interventional, single-center study intends to recruit 515 participants with HFpEF and will be conducted at Massachusetts General Hospital, the sponsor of this study. During the study, patients will undergo a number of tests. These include a 99mTc-pyrophosphate single-photon emission computed tomography (SPECT) scan, blood and DNA (optional) sample collection, electrocardiogram, and echocardiogram.
Read more about hereditary transthyretin amyloidosis epidemiology
In addition, patients will be asked to fill in a questionnaire with items encompassing heart failure symptoms, neuropathy, carpal tunnel syndrome, and frailty. They will be asked to elaborate on how these symptoms have impacted their quality of life. The recruited participants will also be asked to complete a functional assessment (the 6-minute walk test).
The research team will review the electronic health records of the participants for up to 5 years; this is intended to determine their hospitalization and survival rates. The main outcome measure of this study is the proportion of individuals with HFpEF diagnosed with transthyretin amyloidosis according to the 99mTc-pyrophosphate SPECT scans.
This study is estimated to be completed by December 31, 2023. It is a collaboration between Akcea Therapeutics, Pfizer, Alnylam Pharmaceuticals, and Eidos Therapeutics.
Prevalence and prediction of ATTR in ambulatory patients with HFpEF (TTRinHFpEF). ClinicalTrials.gov. October 13, 2022. Accessed November 1, 2022.