Prevalence and Prediction of Transthyretin Amyloidosis in Ambulatory Patients With Heart Failure With Preserved Ejection Fraction (TTRinHFpEF)

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    Massachusetts General Hospital
Updated on 24 October 2022
ejection fraction
heart failure
cardiac amyloidosis
diastolic heart failure


Recent studies have shown that transthyretin amyloidosis (ATTR) can sometimes cause a type of heart failure where the pumping function of the heart is normal, also known as Heart Failure with Preserved Ejection Fraction (HFpEF) or diastolic heart failure. In this single center diagnostic study, we will evaluate for ATTR in patients with HFpEF in order to to determine how frequently this occurs and how we can predict which heart failure patients may have TTR amyloidosis. Our goal is to identify amyloidosis in heart failure patients earlier so that they can start treatment.


Patients 65-years and older with HFpEF will be enrolled to participate in this single center, event driven (positive nuclear amyloid scan also known as 99mTc-pyrophosphate SPECT scan) study.

During the single study visit the following will be obtained:

  • 99mTc-pyrophosphate SPECT scan
  • Blood and DNA (optional) sample collection
  • Questionnaires in regards to neuropathy, carpal tunnel, frailty, and Heart failure symptoms and how they may affect ones quality of life
  • 6-Minute Walk Test
  • ECG (electrocardiogram)
  • Echocardiogram

Electronic health records will be reviewed for up to 5 years in order to determine hospitalization and survival of the study participants. Clinical outcomes of interest include a combined endpoint of days alive outside of the hospital from heart failure hospitalizations at one and five years, presence of autonomic neuropathy, presence of carpal tunnel syndrome, presence of polyneuropathy. Additionally, Individual clinical endpoints are also endpoints of interest.

The results from this study will be used to determine how frequently heart failure patients have transthyretin amyloidosis in their heart and better understand their symptoms. We hope that better understanding transthyretin amyloidosis in heart failure patients will help us identify affected patients so that they can receive treatment.

Condition Transthyretin Amyloidosis, Heart Failure, Heart Failure, Diastolic, Amyloidosis
Treatment 99mTc-pyrophosphate Scintigraphy
Clinical Study IdentifierNCT05577819
SponsorMassachusetts General Hospital
Last Modified on24 October 2022


Yes No Not Sure

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)
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