Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF

Not Applicable

Recruiting

• Conditions: Amyloidosis; Heart Failure; Heart Failure, Diastolic; Transthyretin Amyloidosis
• Interventions: Diagnostic Test: 99mTc-pyrophosphate Scintigraphy

• Registration Number: NCT05577819
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2020-10-02
• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 515

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients 65 and older with Heart Failure with Preserved Ejection Fraction	99mTc-pyrophosphate Scintigraphy	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 Measures

Name	Time	Method
Diagnosis of 99mTc-pyrophosphate scan positive ATTR	Day 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

Secondary Outcome Measures

Name	Time	Method
New York Heart Association function classification	Day 1 (day of study visit)	Classifies the severity of a patients Heart Failure in terms of their limitations during physical activity
Impact of HF as assessed by Kansas City Cardiomyopathy Questionnaire	Day 1 (day of study visit)	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.)
Exercise capacity as determined by a 6-minute walk test	Day 1 (day of study visit)	The 6 minute walk test is used to determine an objective measurement of a patients aerobic capacity and endurance

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States