Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Diagnostic Test: 99mTc-pyrophosphate Scintigraphy
    Cardiac Imaging Technique used to diagnose Transthyretin Cardiac Amyloidosis by use of 15 mCi of 99mTC-Pyrophosphate tracer
    Other names:
    • PYP Scan
    • Pyrophosphate Scan

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Heather Jameson, PhD

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Abbie Macher, BS
617-643-6328
ajmacher@mgh.harvard.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.