Back to resultsTransthyretin Cardiac Amyloidosis in HFpEF
Primary Purpose
Heart Failure With Preserved Ejection Fraction
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
99mTc-PYP
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure With Preserved Ejection Fraction focused on measuring Heart Failure, Diastolic Heart Failure, Heart Failure with Preserved Ejection Fraction, Transthyretin Cardiac Amyloidosis, Amyloidosis
Eligibility Criteria
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
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
Exclusion Criteria
- 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)
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SPECT/CT
Arm Description
99mTc-PYP single-photon positive emission computed tomography with computed tomography
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03414632
First Posted
January 23, 2018
Last Updated
March 18, 2021
Sponsor
Mayo Clinic
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT03414632
Brief Title
Transthyretin Cardiac Amyloidosis in HFpEF
Official Title
Prevalence of Transthyretin Cardiac Amyloidosis in Heart Failure With Preserved Ejection Fraction: A Community Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction
Keywords
Heart Failure, Diastolic Heart Failure, Heart Failure with Preserved Ejection Fraction, Transthyretin Cardiac Amyloidosis, Amyloidosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPECT/CT
Arm Type
Other
Arm Description
99mTc-PYP single-photon positive emission computed tomography with computed tomography
Intervention Type
Drug
Intervention Name(s)
99mTc-PYP
Intervention Description
Radioisotope used in the SPECT/CT imaging
Primary Outcome Measure Information:
Title
Prevalence of TTR-CA
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Exclusion Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar F Abou Ezzeddine
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Transthyretin Cardiac Amyloidosis in HFpEF
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