Scintigraphy for Heart Failure with Amyloidosis
(TTRinHFpEF Trial)
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
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
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
Treatment Details
Interventions
- 99mTc-pyrophosphate Scintigraphy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Akcea Therapeutics
Industry Sponsor
Pfizer
Industry Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Alnylam Pharmaceuticals
Industry Sponsor
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