An interventional study of 99mTc-pyrophosphate Scintigraphy in Transthyretin Amyloidosis, Heart Failure and Heart Failure, Diastolic, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Diagnostic
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:
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.
82 studies on the registry are indexed under Amyloidosis, Hereditary, Transthyretin-Related; 28 are open to participants now.
This study's planned enrollment of 515 is above the median of 80 across 36 interventional studies indexed under Amyloidosis, Hereditary, Transthyretin-Related.
Browse Amyloidosis, Hereditary, Transthyretin-Related studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients 65 years and older presenting to Massachusetts General Hospital with a known diagnosis of HFpEF and without a diagnosis of amyloidosis in the ambulatory (outpatient) setting will undergo a 99Tc-Pyrophosphate Scan to identify Cardiac Amyloidosis
Diagnostic Test: 99mTc-pyrophosphate Scintigraphy
Cardiac Imaging Technique used to diagnose Transthyretin Cardiac Amyloidosis by use of 15 mCi of 99mTC-Pyrophosphate tracer
Also known as: PYP Scan, Pyrophosphate Scan
Diagnosis of 99mTc-pyrophosphate scan positive ATTR
A cardiac disease in which misfolded proteins aggregate into amyloid fibril and deposit interstitially, leading to diastolic dysfunction and heart failure
Time frame: Day 1 (day of study visit)
New York Heart Association function classification
Classifies the severity of a patients Heart Failure in terms of their limitations during physical activity
Time frame: Day 1 (day of study visit)
Impact of HF as assessed by Kansas City Cardiomyopathy Questionnaire
Kansas City Cardiomyopathy Questionnaire is a questionnaire that determines in the impact of Heart Failure on their health status, such as quality of life, symptoms, function, etc.)
Time frame: Day 1 (day of study visit)
Exercise capacity as determined by a 6-minute walk test
The 6 minute walk test is used to determine an objective measurement of a patients aerobic capacity and endurance
Time frame: Day 1 (day of study visit)
Presence of autonomic neuropathy
Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events
Time frame: Time from study Visit until the date of documented event up to 5 years after the study closure
Presence of carpal tunnel syndrome
Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events
Time frame: Time from study Visit until the date of documented event up to 5 years after the study closure
Presence of polyneuropathy
Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events
Time frame: Time from study Visit until the date of documented event up to 5 years after the study closure
Combined endpoint of days alive outside of hospital from HF hospitalizations at one and five years
Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events
Time frame: Time from study Visit until the date of documented event up to 5 years after the study closure
Individual endpoints of all-cause mortality, cardiovascular mortality, all-cause hospitalizations, cardiovascular hospitalizations and HF hospitalizations.
Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events
Time frame: Time from study Visit until the date of documented event up to 5 years after the study closure
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2020 to primary completion in Jul 2026, 69 months.
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Amyloidosis, Hereditary, Transthyretin-Related →
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