ClinicalTrials.gov record NCT05577819

Prevalence and Prediction of ATTR in Ambulatory Patients With HFpEF

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age65 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A single-group diagnostic study enrolling people aged 65 and older with HFpEF. Participants have a single study visit with a 99mTc‑pyrophosphate (PYP) heart scan plus tests (echocardiogram, ECG, 6‑minute walk, questionnaires, optional blood/DNA). Medical records will be reviewed for up to five years to track hospitalizations and survival.

What it is studying. The study is testing how often transthyretin cardiac amyloidosis (ATTR) is present in ambulatory patients with HFpEF and whether clinical features can predict which heart-failure patients have ATTR.

What the researchers hope to learn. To determine how frequently ATTR appears in patients with HFpEF; to identify clinical features that predict ATTR; and to describe associations with symptoms, autonomic neuropathy, carpal tunnel, polyneuropathy, and outcomes such as days alive outside hospital at one and five years.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • 99mTc-pyrophosphate Scintigraphy

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take part in a single study visit that includes a 99mTc-pyrophosphate (PYP) SPECT scan to look for cardiac ATTR. You will be asked to give blood (and optional DNA) samples, complete questionnaires about neuropathy, carpal tunnel, frailty, and heart-failure symptoms, and do a 6-minute walk test, ECG, and echocardiogram. The scan requires lying down for about 15 minutes. Study staff will review your medical records for up to five years to track hospitalizations and survival.

How the study is structured. Single-group interventional diagnostic study with no masking. Participants attend one study visit for a PYP (99mTc‑pyrophosphate) cardiac scan and other tests (echocardiogram, ECG, 6‑minute walk, symptom questionnaires) and may give optional blood/DNA samples. Investigators will review participants' health records for up to five years to record outcomes.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Transthyretin Amyloidosis; Heart Failure; Heart Failure, Diastolic; Amyloidosis. Does it apply to my diagnosis?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 2, 2020
Primary completion
Jul 17, 2026
Study completion
Dec 31, 2026 (estimated)
Target enrollment
515 participants (estimated)
Last updated on registry
Sep 1, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Massachusetts General Hospital
Principal investigator
Hanna Kim Gaggin, Principal Investigator, Associate Professor of Medicine
Massachusetts General Hospital
Collaborators
  • Akcea Therapeutics
  • Pfizer
  • Alnylam Pharmaceuticals
  • Eidos Therapeutics, a BridgeBio company

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Massachusetts General HospitalRecruiting

    Boston, Massachusetts, 02114 · United States

    • Heather Jameson, PhD
    • Hanna Gaggin, MD

Terms used on this page · explanations by MedicalUpdates.ai

eGFR
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
6-Minute Walk Test
A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Echocardiogram
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
endpoint
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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