Status:
COMPLETED
Transthyretin Cardiac Amyloidosis in HFpEF
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Pfizer
Conditions:
Heart Failure With Preserved Ejection Fraction
Eligibility:
All Genders
60+ years
Phase:
EARLY_PHASE1
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 u...
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 ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
December 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT03414632
Start Date
December 1 2017
End Date
March 31 2020
Last Update
March 19 2021
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905