NCT03414632

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
287

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2017

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

2.3 years

First QC Date

January 23, 2018

Last Update Submit

March 18, 2021

Conditions

Heart Failure With Preserved Ejection Fraction

Keywords

Heart FailureDiastolic Heart FailureHeart Failure with Preserved Ejection FractionTransthyretin Cardiac AmyloidosisAmyloidosis

Outcome Measures

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).

    Baseline

Study Arms (1)

SPECT/CT

OTHER

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

Drug: 99mTc-PYP

Interventions

99mTc-PYPDRUG

Radioisotope used in the SPECT/CT imaging

SPECT/CT

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County)
  • Current diagnosis of HF per NLP search
  • Age \> 60 years
  • Clinically obtained echocardiogram within 12 months of index visit showing:
  • EF ≥ 40% and
  • Increased Left Ventricular (LV) wall thickness as defined by an end-diastolic left ventricular septal or posterior wall thickness (LVWTd) ≥ 20% above the upper limit of normal measured by 2D or M-mode imaging in the parasternal long (2D) or short (M-mode) axis view (≥12 mm).
  • Objective evidence of HF defined as one or more of the following present within 24 months of index visit:
  • Meet Framingham Criteria at index visit (In-patient or outpatient)
  • Previous HF hospitalization
  • 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)
  • 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

You may not qualify if:

  • Documentation of previous EF \< 40%
  • Any cardiac surgery or major chest trauma within 4 weeks of index visit
  • Presence or history of hemodynamically significant left sided valvular disease defined as:
  • Greater than mild mitral stenosis
  • Intrinsic mitral valve disease (prolapse, flail) with greater than moderate regurgitation
  • Myocardial infarction within 4 weeks of index visit defined by typical angina, EKG 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.
  • Prior or current exposure to Plaquenil (Hydroxychloroquine)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Heart FailureHeart Failure, DiastolicAmyloidosis

Interventions

Technetium Tc 99m Pyrophosphate

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphatesPolyphosphatesPhosphatesPhosphoric AcidsPhosphorus AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsPhosphorus CompoundsTechnetium Compounds

Study Officials

  • Omar F Abou Ezzeddine

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2018

First Posted

January 30, 2018

Study Start

December 1, 2017

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

US(1)