NCT03414632

Transthyretin Cardiac Amyloidosis in HFpEF

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
DRUG	99mTc-PYP	Radioisotope used in the SPECT/CT imaging

Timeline

• Start date: 2017-12-01
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2018-01-30
• Last updated: 2021-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study