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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 belowSelect...
I am 65 years old or older.
Select...
I have been diagnosed with heart failure with preserved ejection fraction.
TTRinHFpEF Trial 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
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 moreTTRinHFpEF 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
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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
4,570 Previous Clinical Trials
10,915,471 Total Patients Enrolled
31 Trials studying Amyloidosis
11,939 Patients Enrolled for Amyloidosis
Alnylam PharmaceuticalsIndustry Sponsor
72 Previous Clinical Trials
14,303 Total Patients Enrolled
29 Trials studying Amyloidosis
10,663 Patients Enrolled for Amyloidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 65 years old or older.I have never had heart failure with reduced ejection fraction, except during specific acute conditions.I have been diagnosed with heart failure with preserved ejection fraction.I do not have severe untreated heart valve problems.I have been diagnosed with amyloidosis.I am on dialysis for end-stage kidney disease.I cannot lie down for 15 minutes straight.You have had a negative 99mTc-pyrophosphate scan within the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Patients 65 and older with Heart Failure with Preserved Ejection Fraction
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrolment procedures for this clinical trial still underway?
"According to the information made available on clinicaltrials.gov, this trial is still seeking participants as of November 10th 2022; it was first posted two years prior on October 2nd 2020."
Answered by AI
What is the aggregate quantity of participants for this experiment?
"Affirmative. According to clinicaltrials.gov, this medical research trial, which was initially uploaded on October 2nd 2020, is currently enrolling patients. A total of 515 participants are required from a single site."
Answered by AI
Who else is applying?
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
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