Global Prevalence of ATTR-CM in Participants With HFpEF (-)

JRCT ID: jRCT1032200274

Registered date:25/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Transthyretin Amyloid Cardiomyopathy Heart Failure With Preserved Ejection Fraction
• Date of first enrollment: 28/07/2021
• Target sample size: 2000
• Countries of recruitment: Not provided,Japan
• Study type: Interventional
• Intervention(s): Diagnostic Test: Scintigraphy

Outcome(s)

Primary Outcome

Estimate of global prevalence of ATTR-CM in HFpEF patients. [ Time Frame: Visit 1 through Follow-Up Visit 1 ]
Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).

Secondary Outcome

1.Estimate of prevalence of ATTR-CM within region, age and gender [ Time Frame: Visit 1(baseline) through Follow-Up Visit 1]
Includes participants not previously diagnosed with ATTR-CM but found to be positive by scintigraphy at Visit 1 (or subsequent biopsy if grade 1).
2.Prevalence of patients diagnosed ATTR-CM on study with WT and hereditary forms among patients diagnosed with ATTR CM [ Time Frame: Visit 1(baseline) through Follow-Up Visit 1]
3.New York Heart Association (NYHA) Classification of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM [ Time Frame: Visit 1(baseline) through Follow-Up Visit 1]
4.Nt-proBNP results of HFpEF participants diagnosed with ATTR-CM compared with HFpEF participants negative for ATTR-CM [ Time Frame: Visit 1(baseline) through Follow-Up Visit 1]

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Medical history of heart failure (HF) with:
a.At least 1 episode with clinical evidence of HF (without hospitalization) by signs or symptoms of volume overload or elevated intracardiac pressures that required/requires treatment with a diuretic for improvement; OR
b.1 prior hospitalization for HF.
2.Left ventricular ejection fraction (LVEF) >40%.
3.End-diastolic interventricular septal wall thickness (IVST) >=12 mm.
4.Willing and able to undergo scintigraphy.

Exclude criteria

1.Diagnosis of heart failure with reduced ejection fraction (HFrEF) (EF <=40%).
2.Prior clinical history of myocardial infarction, CABG or multi-vessel obstructive coronary disease (>50% stenosis of >=2 epicardial coronary arteries).
3.Presence or history of any severe valvular heart disease (obstructive or regurgitant).
4.A confirmed diagnosis of a non-amyloid infiltrative cardiomyopathy (ie, cardiac sarcoidosis, hemochromatosis), muscular dystrophies, cardiomyopathy with reversible causes, hypertrophic obstructive cardiomyopathy with known genetic etiology, or known pericardial constriction.
5.Any type of diagnosed amyloidosis (eg, amyloid A amyloidosis, primary [light chain] amyloidosis) or prior diagnosis of ATTR-CM.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT04424914