ATTR amyloidosis in patients with heart failure with preserved ejection fraction and a cardiac implantable electronic device

ATTR amyloidosis in patients with heart failure with preserved ejection fraction and a cardiac implantable electronic device - AMYL-VIP-Device study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49286

Enrollment

100

Registered

2020-04-15

Start date

2020-11-01

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Protein misfolding disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Heart failure, NYHA 2 or 3. CIED LVEF > 40% NT-proBNP >400 ng/L sinus rhythm; > 1200 ng/L atrial fibrillation

Exclusion criteria

Exclusion criteria: Unwilling or unable to sign informed consent. Life expectancy

Design outcomes

Primary

Measure	Time frame
The prevalence of ATTR, measured by bone scintigraphy, in HFpEF patients with CIED.	—

Secondary

Measure	Time frame
A) To assess the frequency of (re-)hospitalization of HFpEF patients with a CIED diagnosed with or without transthyretin amyloid cardiomyopathy. B) To assess the clinical characteristics of HFpEF patients also diagnosed with transthyretin amyloid cardiomyopathy. C) To assess the clinical characteristics of HFpEF patients that decrease the likelihood of the presence of transthyretin amyloid cardiomyopathy. D) To assess the mortality of HFpEF patients with a CIED diagnosed with or without transthyretin amyloid cardiomyopathy.	—

Measure

Time frame

A) To assess the frequency of (re-)hospitalization of HFpEF patients with a CIED diagnosed with or without transthyretin amyloid cardiomyopathy. B) To assess the clinical characteristics of HFpEF patients also diagnosed with transthyretin amyloid cardiomyopathy. C) To assess the clinical characteristics of HFpEF patients that decrease the likelihood of the presence of transthyretin amyloid cardiomyopathy. D) To assess the mortality of HFpEF patients with a CIED diagnosed with or without transthyretin amyloid cardiomyopathy.

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Countries

Netherlands

Outcome results