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Clinical Trials/NCT03414632
NCT03414632CompletedEarly Phase 1

Prevalence of Transthyretin Cardiac Amyloidosis in Heart Failure With Preserved Ejection Fraction: A Community Study

Mayo Clinic1 site in 1 country287 target enrollmentStarted: December 1, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
287
Locations
1
Primary Endpoint
Prevalence of TTR-CA

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

SPECT/CT

Other

99mTc-PYP single-photon positive emission computed tomography with computed tomography

Intervention: 99mTc-PYP (Drug)

Outcomes

Primary Outcomes

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Omar Abou Ezzeddine

Principal Investigator

Mayo Clinic

Study Sites (1)

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