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Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF
NCT05577819 · Massachusetts General Hospital
In plain English
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Official title
Prevalence and Prediction of Transthyretin Amyloidosis in Ambulatory Patients With Heart Failure With Preserved Ejection Fraction
About this study
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.
Eligibility criteria
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
Enrollment target: 515 participants
Allocation: na
Masking: none
Age groups: older_adult
Timeline
Starts: 2020-10-02
Estimated completion: 2026-12-31
Last updated: 2026-09-01
Interventions
Diagnostic Test: 99mTc-pyrophosphate Scintigraphy
Primary outcomes
- • Diagnosis of 99mTc-pyrophosphate scan positive ATTR (Day 1 (day of study visit))
Sponsor
Massachusetts General Hospital · other
With: Akcea Therapeutics, Pfizer, Alnylam Pharmaceuticals, Eidos Therapeutics, a BridgeBio company
Contacts & investigators
ContactAbbie Macher, BS · contact · ajmacher@mgh.harvard.edu · 617-643-6328
ContactLaura Stockhausen, BS · contact · lstockhausen@mgh.harvard.edu · 617-724-1339
InvestigatorHanna K Gaggin, MD · principal_investigator, Massachusetts General Hospital
All locations (1)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States