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CompletedNCT03414632Updated Mar 19, 2021

Transthyretin Cardiac Amyloidosis in HFpEF

An Early Phase 1 interventional study of 99mTc-PYP in Heart Failure With Preserved Ejection Fraction, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-03-19.

Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Mar 2020, 6 years 7 months ago, and no results have been posted to the registry.

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Phase
Early Phase 1
Study type
Interventional
Enrollment
287
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 69 studies in Heart Failure by Mayo Clinic — 16 open to participants now, 17 under way, none of them phase 3. Heart Failure · Mayo Clinic.

Enrollment
5th of 48
287 · median 36
Started
2017
with 4 others
Phase 1
9 of 69
1 open now
Registered
38th of 69
by date

Among the 69 studies in Heart Failure by Mayo Clinic, this one is the 5th largest by enrollment of the 48 interventional ones that give a count, is one of 5 that started in 2017, is one of 9 in phase 1, and was the 38th registered.

Heart Failure

6,332 studies on the registry are indexed under Heart Failure; 1,392 are open to participants now.

Browse Heart Failure studies →

Open to participants now

16 of the 69 studies in Heart Failure by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:

11 more — sign in →

By country, each count listing its studies:

United States16

All 16 open studies →

Where they have run

United States63
Canada1

Who these studies take

Of the 966 Heart Failure studies recruiting now, 689 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 63 take children under 18; 96 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

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02

Study summary

To estimate the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among Heart Failure with Preserved Ejection Fraction (HFpEF) patients with increased LV wall thickness in Southeast Minnesota using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).

Read the detailed description

Residents of Southeast Minnesota over 60 years of age with an inpatient or outpatient diagnosis of heart failure (HF) will be consecutively identified in real-time using a natural language processing (NLP) search engine, their HF diagnosis validated, and those with a recent (≤ 12 months) echocardiogram documenting a preserved EF( ≥ 40%) and LV wall thickening will be consented to undergo venipuncture, urine collection and 99mTc-PYP SPECT/CT imaging to rule in/out the diagnosis of TTR-CA. Hence, the prevalence of TTR-CA will be defined. To place this prevalence in perspective of the global HFpEF cohort in the community, a rigorous screening log will be maintained to allow generation of a comprehensive CONSORT diagram. Importantly, baseline characteristics of patients who qualify for our study but decline to consent will still be collected provided that consent for use of their records for medical research had previously been granted.

03

Conditions studied

  • Heart Failure With Preserved Ejection Fraction

Keywords

  • Heart Failure
  • Diastolic Heart Failure
  • Heart Failure with Preserved Ejection Fraction
  • Transthyretin Cardiac Amyloidosis
  • Amyloidosis
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County)
  2. Current diagnosis of HF per NLP search
  3. Age > 60 years

  4. Clinically obtained echocardiogram within 12 months of index visit showing:

    1. EF ≥ 40% and
    2. Increased Left Ventricular (LV) wall thickness as defined by an end-diastolic left ventricular septal or posterior wall thickness (LVWTd) ≥ 20% above the measured by 2D or M-mode imaging in the parasternal long (2D) or short (M-mode) axis view (≥12 mm).

  5. Objective evidence of HF defined as one or more of the following present within 24 months of index visit:

    1. Meet Framingham Criteria at index visit (In-patient or outpatient)
    2. Previous HF hospitalization
    3. Invasive hemodynamic documentation of elevated pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) (> 18 mmHg at rest or > 25 mmHg with exercise)
    4. Left atrial enlargement + loop diuretic for HF(clinically obtained) N-terminal pro b-type natriuretic peptide (NT-proBNP) > 300 (sinus rhythm) or >900 (atrial fibrillation) pg/mL

Exclusion criteria

Exclusion Criteria

  1. Documentation of previous EF \< 40%
  2. Any cardiac surgery or major chest trauma within 4 weeks of index visit

  3. Presence or history of hemodynamically significant left sided valvular disease defined as:

    1. Greater than mild mitral stenosis
    2. Intrinsic mitral valve disease (prolapse, flail) with greater than moderate regurgitation
  4. Myocardial infarction within 4 weeks of index visit defined by typical angina, changes and significant change in serial troponins. Note that chronic troponin elevation is extremely common in cardiac amyloidosis. Hospitalized patients with troponin elevation but no significant change (delta) on serial testing will NOT be excluded.
  5. Prior or current exposure to Plaquenil (Hydroxychloroquine)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
287 participants (actual)

Study arms

  • Other
    SPECT/CT

    99mTc-PYP single-photon positive emission computed tomography with computed tomography

    Drug: 99mTc-PYP

Interventions

  • Drug99mTc-PYP

    Radioisotope used in the SPECT/CT imaging

06

What researchers measure

Primary outcomes

  1. Prevalence of TTR-CA

    Determine the prevalence of Transthyretin Cardiac Amyloidosis in a community based cohort of consecutive Heart Failure with Preserved Ejection Fraction patients with increased Left Ventricular wall thickness using 99mTc-Pyrophosphate (99mTc-PYP) single-photon positive emission computed tomography with computed tomography (SPECT/CT).

    Time frame: Baseline

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Mar 2020, 27 months.

Of 54 non-industry phase 1 interventional studies under Heart Failure, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 58. This study's 27 months is below that.

Counting every sponsor, half of 131 studies reached it within 14 months; a quarter within 4 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2018
First posted
Jan 30, 2018
StartActual
Dec 1, 2017
Primary completionActual
Mar 31, 2020
CompletionActual
Mar 31, 2020
Last update
Mar 19, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03414632
Lead sponsor
Mayo Clinic
Collaborators
Pfizer
Responsible party
Omar Abou Ezzeddine (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jan 30, 2018
Start date
Dec 1, 2017
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Last update
Mar 19, 2021

Study contacts

Omar F Abou Ezzeddine
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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