NCT05577819

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
515

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Oct 2020Dec 2026

Study Start

First participant enrolled

October 2, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2021

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

5.7 years

First QC Date

July 16, 2021

Last Update Submit

December 6, 2024

Conditions

Transthyretin AmyloidosisHeart FailureHeart Failure, DiastolicAmyloidosis

Keywords

Transthyretin AmyloidosisHeart FailureHeart Failure, DiastolicAmyloidosis

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of 99mTc-pyrophosphate scan positive ATTR

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

    Day 1 (day of study visit)

Secondary Outcomes (3)

  • New York Heart Association function classification

    Day 1 (day of study visit)

  • Impact of HF as assessed by Kansas City Cardiomyopathy Questionnaire

    Day 1 (day of study visit)

  • Exercise capacity as determined by a 6-minute walk test

    Day 1 (day of study visit)

Other Outcomes (5)

  • Presence of autonomic neuropathy

    Time from study Visit until the date of documented event up to 5 years after the study closure

  • Presence of carpal tunnel syndrome

    Time from study Visit until the date of documented event up to 5 years after the study closure

  • Presence of polyneuropathy

    Time from study Visit until the date of documented event up to 5 years after the study closure

  • +2 more other outcomes

Study Arms (1)

Patients 65 and older with Heart Failure with Preserved Ejection Fraction

EXPERIMENTAL

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

Interventions

99mTc-pyrophosphate ScintigraphyDIAGNOSTIC_TEST

Cardiac Imaging Technique used to diagnose Transthyretin Cardiac Amyloidosis by use of 15 mCi of 99mTC-Pyrophosphate tracer

Also known as: PYP Scan, Pyrophosphate Scan
Patients 65 and older with Heart Failure with Preserved Ejection Fraction

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Amyloidosis, Hereditary, Transthyretin-RelatedHeart FailureHeart Failure, DiastolicAmyloidosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Hanna K Gaggin, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abbie Macher, BS

CONTACT

617-643-6328ajmacher@mgh.harvard.edu

Laura Stockhausen, BS

CONTACT

617-724-1339lstockhausen@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor of Medicine

Study Record Dates

First Submitted

July 16, 2021

First Posted

October 13, 2022

Study Start

October 2, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations

US(1)