NCT05577819

Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF

Prevalence and Prediction of Transthyretin Amyloidosis in Ambulatory Patients With Heart Failure With Preserved Ejection Fraction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 515 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2020-10-02
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2022-10-13
• Last updated: 2024-12-09

Locations

1 site across 1 country: United States