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NCT Number: NCT05577819

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.

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Key information

Conditions

Transthyretin Amyloidosis Amyloidosis Amyloidosis, Hereditary, Transthyretin-Related Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Diastolic Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Hanna Gaggin, MD

PRINCIPAL_INVESTIGATOR

Heather Jameson, PhD

CONTACT

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

99mTc-pyrophosphate Scintigraphy

Diagnostic Test

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

Other names: PYP Scan, Pyrophosphate Scan

Primary outcomes

  1. Diagnosis of 99mTc-pyrophosphate scan positive ATTR

    Time frame: Day 1 (day of study visit)

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

Secondary outcomes

  1. New York Heart Association function classification

    Time frame: Day 1 (day of study visit)

    Classifies the severity of a patients Heart Failure in terms of their limitations during physical activity

  2. Impact of HF as assessed by Kansas City Cardiomyopathy Questionnaire

    Time frame: Day 1 (day of study visit)

    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.)

  3. Exercise capacity as determined by a 6-minute walk test

    Time frame: Day 1 (day of study visit)

    The 6 minute walk test is used to determine an objective measurement of a patients aerobic capacity and endurance

Other outcomes

  1. Presence of autonomic neuropathy

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

    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

  2. Presence of carpal tunnel syndrome

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

    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

  3. Presence of polyneuropathy

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

    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

  4. Combined endpoint of days alive outside of hospital from HF hospitalizations at one and five years

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

    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

  5. Individual endpoints of all-cause mortality, cardiovascular mortality, all-cause hospitalizations, cardiovascular hospitalizations and HF hospitalizations.

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Abbie Macher, BS

CONTACT

[email protected]

617-643-6328

Laura Stockhausen, BS

CONTACT

[email protected]

617-724-1339

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Akcea Therapeutics
  • Alnylam Pharmaceuticals
  • Eidos Therapeutics, a BridgeBio company
  • Pfizer

Registry information

Official study title

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

Acronym: TTRinHFpEF

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 13, 2022
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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