A Study to Evaluate the Prevalence of Transthyretin Cardiac Amyloidosis in Heart Failure Patients with Preserved Ejection Fraction in Southeastern Minnesota

Overview

About this study

The primary objective of this study is to determine the prevalence of transthyretin cardiac amyloidosis (TTR-CA) in a community-based cohort of consecutive heart failure with preserved ejection fraction (HFpEF) patients with increased LV wall thickness using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT). As a secondary (exploratory) objective, we seek to establish and validate novel biomarker assays to screen for TTR-CA using blood and urine samples collected from study participants.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County).
  • Current diagnosis of HF per NLP search.
  • Age ≥ 60 years old.
  • Clinically obtained cardiac imaging within 12 months of screening visit showing:
    • EF ≥ 40%; and
    • Cardiac imaging from any time point showing increased 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 screening visit:
    • Meets Framingham Criteria at screening visit (in-patient or outpatient);
    • Previous HF hospitalization ;
    • Invasive hemodynamic documentation of elevated PCWP or LVEDP (> 18 mmHg at rest or > 25 mmHg with exercise);
    • Left atrial enlargement + loop diuretic for HF;
    • Clinically obtained NT-proBNP > 300 (sinus rhythm) or > 900 (atrial fibrillation) pg/mL.

Exclusion Criteria:

  • Documentation of previous EF < 40%.
  • Any cardiac surgery or major chest trauma within 4 weeks of testing visit.
  • Presence or history of hemodynamically significant left sided valvular disease defined as:
    • Greater than mild mitral stenosis;
    • Greater than moderate mitral regurgitation caused by intrinsic mitral valve disease (prolapse, flail).
  • Myocardial infarction within 4 weeks of testing 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).

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Omar Abou Ezzeddine, M.D., C.M., M.S.

Closed for enrollment

Contact information:

Jasmine Sexton CCRP

(507)538-7178

Sexton.Jasmine@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20344118

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