Diagnosing ATTR in Heart Failure with Preserved Ejection Fraction

This study aims to understand how often transthyretin amyloidosis (ATTR) causes a type of heart failure called Heart Failure with Preserved Ejection Fraction (HFpEF), where the heart pumps normally but doesn't relax properly. Researchers will use a diagnostic test called 99mTc-pyrophosphate Scintigraphy, a cardiac imaging technique, to look for ATTR in people with HFpEF. The main goal is to see how frequently ATTR is diagnosed using this scan. You may be able to join if you are 65 or older and have a confirmed diagnosis of HFpEF. The study hopes to identify ATTR earlier in heart failure patients so they can receive appropriate treatment. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 515 participants. It is a single-center diagnostic study.
What's involved
You would have a single study visit where you would receive a 99mTc-pyrophosphate SPECT scan, provide blood and optional DNA samples, complete questionnaires, perform a 6-Minute Walk Test, and have an ECG and echocardiogram.
Compensation
Not stated in the trial record.
Follow-up
Your electronic health records will be reviewed for up to 5 years to track hospitalizations and survival.

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NCT05577819

Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF

Recruiting
NAAges 65+InterventionalDiagnostic
Massachusetts General Hospital
~515 participants
Updated 2024-12-09 on ClinicalTrials.gov
What's tested:99mTc-pyrophosphate Scintigraphy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Diagnosis of 99mTc-pyrophosphate scan positive ATTR
Measured over Day 1 (day of study visit)
Transthyretin Amyloidosis
Heart Failure
Heart Failure, Diastolic
Amyloidosis
1 sites across 1 states
Massachusetts1
  • Hanna K Gaggin, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients with a confirmed diagnosis of HFpEF.
Age ≥65 years old

Exclusion

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)
  • Diagnosis of 99mTc-pyrophosphate scan positive ATTRDay 1 (day of study visit)

    A cardiac disease in which misfolded proteins aggregate into amyloid fibril and deposit interstitially, leading to diastolic dysfunction and heart failure