515 Participants Needed

Scintigraphy for Heart Failure with Amyloidosis

(TTRinHFpEF Trial)

JC
LS
KW
AM
Overseen ByAbbie Macher, BS
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of 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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the effectiveness of the treatment 99mTc-pyrophosphate Scintigraphy for heart failure with amyloidosis?

Research shows that 99mTc-pyrophosphate scintigraphy is a sensitive and specific test for diagnosing cardiac amyloidosis, especially in patients with heart failure of unknown cause. It has been found to be effective in identifying amyloid deposits in the heart, which can help in diagnosing the condition accurately.12345

Is 99mTc-PYP scintigraphy safe for humans?

The research does not provide specific safety data for 99mTc-PYP scintigraphy, but it is commonly used in clinical practice for diagnosing cardiac amyloidosis, suggesting it is generally considered safe.35678

How does scintigraphy differ from other treatments for heart failure with amyloidosis?

Scintigraphy, specifically using technetium-99m pyrophosphate, is unique because it is a non-invasive imaging technique that helps diagnose cardiac amyloidosis by detecting abnormal protein deposits in the heart. Unlike other treatments that may focus on managing symptoms, this method provides a sensitive and specific way to identify the disease, which can guide further treatment decisions.15678

Research Team

HK

Hanna Gaggin, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for people aged 65 or older who have been diagnosed with a type of heart failure where the heart pumps normally (HFpEF). They can't join if they've had severe untreated heart valve disease, certain types of past heart failure, a negative scan for amyloid buildup in the last year, trouble lying down for scans, known amyloidosis, or are on dialysis due to advanced kidney disease.

Inclusion Criteria

I am 65 years old or older.
I have been diagnosed with heart failure with preserved ejection fraction.

Exclusion Criteria

I have never had heart failure with reduced ejection fraction, except during specific acute conditions.
I do not have severe untreated heart valve problems.
I have been diagnosed with amyloidosis.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Study Visit

Participants undergo a single study visit for diagnostic evaluations including 99mTc-pyrophosphate SPECT scan, blood and DNA sample collection, questionnaires, 6-Minute Walk Test, ECG, and Echocardiogram

1 day
1 visit (in-person)

Follow-up

Participants' electronic health records are reviewed for up to 5 years to determine hospitalization and survival, with phone follow-ups to ascertain vital status and significant clinical events

5 years

Treatment Details

Interventions

  • 99mTc-pyrophosphate Scintigraphy
Trial OverviewThe study is using a special imaging test called '99mTc-pyrophosphate Scintigraphy' to see how often patients with HFpEF also have ATTR amyloidosis—a condition where abnormal proteins build up in the body. The goal is to find out better ways to predict and diagnose this issue early in heart failure patients.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Patients 65 and older with Heart Failure with Preserved Ejection FractionExperimental Treatment1 Intervention
Patients 65 years and older presenting to Massachusetts General Hospital with a known diagnosis of HFpEF and without a diagnosis of amyloidosis in the ambulatory (outpatient) setting will undergo a 99Tc-Pyrophosphate Scan to identify Cardiac Amyloidosis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials
3,066
Recruited
13,430,000+

Akcea Therapeutics

Industry Sponsor

Trials
24
Recruited
2,000+

Pfizer

Industry Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Alnylam Pharmaceuticals

Industry Sponsor

Trials
81
Recruited
16,100+

Dr. Yvonne Greenstreet

Alnylam Pharmaceuticals

Chief Executive Officer since 2021

MD from the University of Leeds, MBA from INSEAD

Dr. Pushkal Garg

Alnylam Pharmaceuticals

Chief Medical Officer since 2016

MD from Columbia University

Eidos Therapeutics, a BridgeBio company

Industry Sponsor

Trials
12
Recruited
2,400+

Findings from Research

Technetium-99m-labeled pyrophosphate (PYP) and DPD are effective imaging agents for diagnosing cardiac amyloidosis, capable of differentiating between light chain (AL) and transthyretin (TTR) types of the disease.
The study observed a unique pattern of increased uptake in soft tissues while sparing the organs typically most affected by cardiac amyloidosis, suggesting a distinct imaging profile for these agents.
Unusually seen pattern of 99mTc-DPD soft tissue uptake in a patient with AL amyloidosis. Is it an amyloid type indicator in specific cases?Doumas, A., Armenis, I., Chatzoglou, V., et al.[2023]
Scintigraphy using 99mTc-labeled methylene-diphosphonate (99mTc-MDP) and pyrophosphate (99mTc-PYP) is an effective noninvasive screening method for assessing organ involvement in various types of amyloidosis, including systemic AA and AL amyloidosis.
While 99mTc-MDP and 99mTc-PYP scintigraphy are useful for detecting amyloidosis, echocardiography is more sensitive for identifying cardiac involvement, highlighting the need for complementary diagnostic approaches.
Soft-tissue uptake of 99mTc-diphosphonate and 99mTc-pyrophosphate in amyloidosis.Janssen, S., Piers, DA., van Rijswijk, MH., et al.[2019]
99 mTc-PYP scintigraphy demonstrated high sensitivity (88.9%) and specificity (95.0%) for diagnosing ATTR cardiac amyloidosis, making it a valuable tool in clinical practice for identifying this condition, especially in elderly patients.
The study involved 98 patients, with 29 undergoing endomyocardial biopsy, highlighting that 99 mTc-PYP scintigraphy can effectively screen for ATTR amyloidosis, which is often challenging to diagnose based solely on clinical symptoms.
Utility of 99 mTc-Pyrophosphate Scintigraphy in Diagnosing Transthyretin Cardiac Amyloidosis in Real-World Practice.Tsutsui, Y., Kubota, T., Kato, S., et al.[2021]

References

Unusually seen pattern of 99mTc-DPD soft tissue uptake in a patient with AL amyloidosis. Is it an amyloid type indicator in specific cases? [2023]
Soft-tissue uptake of 99mTc-diphosphonate and 99mTc-pyrophosphate in amyloidosis. [2019]
Utility of 99 mTc-Pyrophosphate Scintigraphy in Diagnosing Transthyretin Cardiac Amyloidosis in Real-World Practice. [2021]
Novel method for quantitative evaluation of cardiac amyloidosis using (201)TlCl and (99m)Tc-PYP SPECT. [2016]
Sensitivity of technetium-99m-pyrophosphate scintigraphy in diagnosing cardiac amyloidosis. [2019]
Direct comparison of diagnostic and clinical values between Tc-99 m DPD and Tc-99 m PYP scintigraphy in patients with cardiac amyloidosis. [2023]
Multicenter Study of Planar Technetium 99m Pyrophosphate Cardiac Imaging: Predicting Survival for Patients With ATTR Cardiac Amyloidosis. [2022]
A case report of an uncommon presentation of 99mtechnetium pyrophosphate scintigraphy in transthyretin cardiac amyloidosis: A potential diagnostic pitfall, pseudo-positive or pseudo-negative? [2020]