Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a confirmed diagnosis of HFpEF.
Age ≥65 years old
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
99mTc-pyrophosphate Scintigraphy
Diagnostic testCardiac Imaging Technique used to diagnose Transthyretin Cardiac Amyloidosis by use of 15 mCi of 99mTC-Pyrophosphate tracer
Treatment groups
515 Participants
are divided into 1 treatment groupGroup A: Patients 65 and older with Heart Failure with Preserved Ejection FractionExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Day 1 (day of study visit)Secondary outcomes
1
New York Heart Association function classification
Classifies the severity of a patients Heart Failure in terms of their limitations during physical activity
Time frame
Day 1 (day of study visit)2
Impact of HF as assessed by Kansas City Cardiomyopathy Questionnaire
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.)
Time frame
Day 1 (day of study visit)3
Exercise capacity as determined by a 6-minute walk test
The 6 minute walk test is used to determine an objective measurement of a patients aerobic capacity and endurance
Time frame
Day 1 (day of study visit)Other outcomes
1
Presence of autonomic neuropathy
Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events
Time frame
Time from study Visit until the date of documented event up to 5 years after the study closure2
Presence of carpal tunnel syndrome
Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events
Time frame
Time from study Visit until the date of documented event up to 5 years after the study closure3
Presence of polyneuropathy
Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events
Time frame
Time from study Visit until the date of documented event up to 5 years after the study closure4
Combined endpoint of days alive outside of hospital from HF hospitalizations at one and five years
Medical records and phone follow-up with patients and/or their physicians will allow the investigators to ascertain vital status and any significant clinical events
Time frame
Time from study Visit until the date of documented event up to 5 years after the study closureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Akcea Therapeutics
Collaborator
Pfizer
Collaborator
Alnylam Pharmaceuticals
Collaborator
Eidos Therapeutics, a BridgeBio company
Collaborator
Source ClinicalTrials.gov