Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05577819
Status
Recruiting

Conditions

  • Amyloidosis
  • Heart Failure
  • Heart Failure, Diastolic
  • Transthyretin Amyloidosis

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 99mTc-pyrophosphate Scintigraphy — DIAGNOSTIC_TEST
    Cardiac Imaging Technique used to diagnose Transthyretin Cardiac Amyloidosis by use of 15 mCi of 99mTC-Pyrophosphate tracer

Study Details

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.

Key Dates

Start date
Oct 2, 2020
Status verified
Dec 2024
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
515 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients 65 and older with Heart Failure with Preserved Ejection Fraction
    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

Primary Outcome Measure

Diagnosis of 99mTc-pyrophosphate scan positive ATTR [ Time Frame: Day 1 (day of study visit) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Heather Jameson, PhD
Hanna Gaggin, MD (PRINCIPAL_INVESTIGATOR)

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