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Transthyretin Cardiac Amyloidosis in HFpEF

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ClinicalTrials.gov Identifier: NCT03414632
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Omar Abou Ezzeddine, Mayo Clinic

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).

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Drug: 99mTc-PYP Early Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Transthyretin Cardiac Amyloidosis in Heart Failure With Preserved Ejection Fraction: A Community Study
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
SPECT/CT
99mTc-PYP single-photon positive emission computed tomography with computed tomography
Drug: 99mTc-PYP
Radioisotope used in the SPECT/CT imaging




Primary Outcome Measures :
  1. Prevalence of TTR-CA [ Time Frame: Baseline ]
    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).



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 upper limit of normal 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

  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, 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.
  5. Prior or current exposure to Plaquenil (Hydroxychloroquine)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414632


Contacts
Contact: Sue Milbrandt 507-538-6105 milbrandt.susan@mayo.edu
Contact: Trevor Stromme 507-293-2754 stromme.trevor@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Pfizer
Investigators
Principal Investigator: Omar F Abou Ezzeddine Mayo Clinic

Responsible Party: Omar Abou Ezzeddine, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03414632     History of Changes
Other Study ID Numbers: 17-003021
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Omar Abou Ezzeddine, Mayo Clinic:
Heart Failure
Diastolic Heart Failure
Heart Failure with Preserved Ejection Fraction
Transthyretin Cardiac Amyloidosis
Amyloidosis

Additional relevant MeSH terms:
Heart Failure
Amyloidosis
Heart Diseases
Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases