← Back to Search

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

Must not have

Severe valvular heart disease that is uncorrected (moderate to severe is considered exclusionary)

Known diagnosis of amyloidosis

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 65 years old or older.

Select...

I have been diagnosed with heart failure with preserved ejection fraction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe untreated heart valve problems.

Select...

I have been diagnosed with amyloidosis.

Select...

I am on dialysis for end-stage kidney disease.

Select...

I cannot lie down for 15 minutes straight.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from study visit until the date of documented event up to 5 years after the study closure

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnosis of 99mTc-pyrophosphate scan positive ATTR

Secondary study objectives

Exercise capacity as determined by a 6-minute walk test

Cardiomyopathies

New York Heart Association function classification

Other study objectives

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

Perinatal death

Presence of autonomic neuropathy

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met