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Trial record 1 of 1 for:    NCT03414632
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Transthyretin Cardiac Amyloidosis in HFpEF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03414632
Recruitment Status : Active, not recruiting
First Posted : January 30, 2018
Last Update Posted : August 26, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Omar Abou Ezzeddine, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 23, 2018
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date August 26, 2020
Actual Study Start Date  ICMJE December 1, 2017
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transthyretin Cardiac Amyloidosis in HFpEF
Official Title  ICMJE Prevalence of Transthyretin Cardiac Amyloidosis in Heart Failure With Preserved Ejection Fraction: A Community Study
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).
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Heart Failure With Preserved Ejection Fraction
Intervention  ICMJE Drug: 99mTc-PYP
Radioisotope used in the SPECT/CT imaging
Study Arms  ICMJE SPECT/CT
99mTc-PYP single-photon positive emission computed tomography with computed tomography
Intervention: Drug: 99mTc-PYP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 25, 2020)
287
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
300
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03414632
Other Study ID Numbers  ICMJE 17-003021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Omar Abou Ezzeddine, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Omar F Abou Ezzeddine Mayo Clinic
PRS Account Mayo Clinic
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP