Evaluating the prevalence of transthyretin amyloidosis in heart failure patients
Official title: Prevalence and Prediction of Transthyretin Amyloidosis in Ambulatory Patients With Heart Failure With Preserved Ejection Fraction
Run by Massachusetts General Hospital · NCT05577819 · Data updated 2026-11-12
This study is trying to find out how common transthyretin amyloidosis is in older heart failure patients to help catch it early for better treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 515 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | October 2, 2020 |
| Main results expected | July 17, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 1, 2026 |
| Trial ID | NCT05577819 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients aged 65 and older with a confirmed diagnosis of heart failure with preserved ejection fraction.
✕Probably not a fit
Patients with end-stage chronic kidney disease on dialysis or a known diagnosis of amyloidosis will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess how often transthyretin amyloidosis (ATTR) occurs in patients aged 65 and older with heart failure with preserved ejection fraction (HFpEF). Participants will undergo a 99mTc-pyrophosphate SPECT scan, along with blood sample collection and various assessments related to their heart failure symptoms and quality of life. The study will also review electronic health records to track hospitalization and survival outcomes over five years. The goal is to identify ATTR in heart failure patients earlier to facilitate timely treatment.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and treatment of transthyretin amyloidosis in heart failure patients, improving their quality of life and health outcomes.
How similar studies have gone: Other studies have shown promising results in identifying ATTR in heart failure patients, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with a confirmed diagnosis of HFpEF. * Age ≥65 years old Exclusion Criteria: * End stage chronic kidney disease on dialysis (CKD stage 5 as defined as eGFR \<15mL/min) * no history of HFrEF (LVEF\<40%) with the exception of low LVEF in the setting of acute decompensation, AF RVR, ACS/MI, etc * Negative 99mTc-pyrophosphate scan within a year * Unable to lie down for 15 minutes for the 99mTc-pyrophosphate scan * Known diagnosis of amyloidosis * Severe valvular heart disease that is uncorrected (moderate to severe is considered exclusionary)
Where it's running
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Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Hanna K Gaggin, MD — Massachusetts General Hospital
- Study coordinator: Abbie Macher, BS
- Email: ajmacher@mgh.harvard.edu
- Phone: 617-643-6328
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing Aortix Device to Diuretics for Acute Heart Failure
This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.
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Acoramidis for ATTR-CM: Cardiac Imaging Study
This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.
-
LY3971297 in heart failure: safety and tolerability in HF with preserved and reduced ejection fraction
This study tests how well LY3971297 is tolerated and what side effects occur in people with HFpEF or HFrEF.
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Using Apple Watch data to predict heart failure outcomes
This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.
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Preventing transthyretin amyloidosis in young carriers of a genetic variant
This study is testing if a medication called acoramidis can help prevent transthyretin amyloidosis in young adults who carry a specific genetic variant that puts them at risk for the disease.
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Evaluating Iodine-124 Evuzumitide in Patients with Systemic Amyloidosis
This study is testing how a new imaging agent called iodine-124 evuzumitide works in people with systemic amyloidosis, especially those with heart issues, to see how it affects their organs and overall health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.