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Scintigraphy for Heart Failure with Amyloidosis (TTRinHFpEF Trial)

N/A
Recruiting
Led By Hanna K Gaggin, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥65 years old
Patients with a confirmed diagnosis of HFpEF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from study visit until the date of documented event up to 5 years after the study closure
Awards & highlights

TTRinHFpEF Trial Summary

This trial will study if a type of heart failure caused by amyloidosis can be diagnosed earlier to help patients get treatment faster. #HFpEF #ATTR #Amyloidosis

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since this trial involves diagnostic imaging rather than medication or surgery, side effects are minimal but may include discomfort from lying still during the scan and very low exposure to radiation.

TTRinHFpEF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
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I have been diagnosed with heart failure with preserved ejection fraction.

TTRinHFpEF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from study visit until the date of documented event up to 5 years after the study closure
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from study visit until the date of documented event up to 5 years after the study closure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnosis of 99mTc-pyrophosphate scan positive ATTR
Secondary outcome measures
Exercise capacity as determined by a 6-minute walk test
Cardiomyopathies
New York Heart Association function classification
Other outcome measures
Combined endpoint of days alive outside of hospital from HF hospitalizations at one and five years
Perinatal death
Presence of autonomic neuropathy
+2 more

TTRinHFpEF Trial Design

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 Location

Who is running the clinical trial?

Akcea TherapeuticsIndustry Sponsor
23 Previous Clinical Trials
1,522 Total Patients Enrolled
3 Trials studying Amyloidosis
335 Patients Enrolled for Amyloidosis
PfizerIndustry Sponsor
4,583 Previous Clinical Trials
14,635,094 Total Patients Enrolled
32 Trials studying Amyloidosis
11,989 Patients Enrolled for Amyloidosis
Alnylam PharmaceuticalsIndustry Sponsor
74 Previous Clinical Trials
14,539 Total Patients Enrolled
30 Trials studying Amyloidosis
10,863 Patients Enrolled for Amyloidosis

Media Library

Patients 65 and older with Heart Failure with Preserved Ejection Fraction Clinical Trial Eligibility Overview. Trial Name: NCT05577819 — N/A
Amyloidosis Research Study Groups: Patients 65 and older with Heart Failure with Preserved Ejection Fraction
Amyloidosis Clinical Trial 2023: Patients 65 and older with Heart Failure with Preserved Ejection Fraction Highlights & Side Effects. Trial Name: NCT05577819 — N/A
Patients 65 and older with Heart Failure with Preserved Ejection Fraction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05577819 — N/A
~0 spots leftby Jun 2024
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