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Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF
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.
Conditions:
🦠 Transthyretin Amyloidosis 🦠 Heart Failure 🦠 Heart Failure, Diastolic 🦠 Amyloidosis
🗓️ Study Start (Actual) 2 October 2020
🗓️ Primary Completion (Estimated) 30 June 2024
✅ Study Completion (Estimated) 31 December 2024
👥 Enrollment (Estimated) 515
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 65 Years to N/A (OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 July 2021
  • First Submitted that Met QC Criteria 11 October 2022
  • First Posted 13 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 May 2024
  • Last Update Posted 3 June 2024
  • Last Verified May 2024
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