Evaluating the prevalence of transthyretin amyloidosis in heart failure patients
Prevalence and Prediction of Transthyretin Amyloidosis in Ambulatory Patients With Heart Failure With Preserved Ejection Fraction
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 515 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05577819 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 and older with a confirmed diagnosis of heart failure with preserved ejection fraction.
Not a fit: Patients with end-stage chronic kidney disease on dialysis or a known diagnosis of amyloidosis will not benefit from this study.
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 performed: Other studies have shown promising results in identifying ATTR in heart failure patients, suggesting that this approach may be effective.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- 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
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.