A Multicenter Study Aiming to Clarify the Prevalence and Clinical Implications of ATTR Cardiac Amyloidosis in Patients with Heart Failure with Preserved/Mid-range Ejection Fraction

A Multicenter Study Aiming to Clarify the Prevalence and Clinical Implications of ATTR Cardiac Amyloidosis in Patients with Heart Failure with Preserved/Mid-range Ejection Fraction - UNVEIL-ATTR-CA

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031210714

Enrollment

500

Registered

2022-03-31

Start date

2022-02-10

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Heart failure Preserved/Mid-range Ejection Fraction, ATTR Cardiac Amyloidosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: i)Age >= 70 years old and =40% iv)Maximal left ventricular wall thickness >10 mm by echocardiography or CMR performed within 3 months v)Those who have obtained written consent for participation in the study

Exclusion criteria

Exclusion criteria: i)Amyloid has been already proven histologically ii)Any cardiac surgery or major chest trauma within 4 weeks of index visit iii)Treatment of heart failure with intravenous drugs iv)History of myocardial infarction, and history of coronary artery disease needed coronary artery revascularization, including PCI/CABG within 6 months v)Uncontrolled infection, or active malignancy, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer vi)Received or planned liver transplant or heart transplant

Design outcomes

Primary

Measure	Time frame
Diagnosis of ATTR-CA by meeting both of the following 1 and 2 1. Tc-99m pyrophosphate scintigraphy meeting the criteria of visual score >= 2 at 1 hour or 3 hours. 2. 2. No M protein detected by serum immunofixation, abnormal serum free light chain kappa/lambda ratio (1.65), or urine immunofixation	—

Secondary

Measure	Time frame
i) Event rate (all-cause mortality, heart failure rehospitalization, thromboembolism, and new cardiac conduction defects) within 1 year from the date of Tc-99m pyrophosphate scintigraphy in ATTR-CA patients compared to non-ATTR-CA HFp/mrEF patients. ii) Biomarker profiles (high-sensitivity troponin, NT-proBNP, creatinine, blood urea nitrogen, albumin, prealbumin, high-sensitivity C-reactive protein) and patient background factors in ATTR-CA patients compared to non-ATTR-CA patients with HFp/mrEF. iii) Comparison of exercise tolerance assessment by cardiopulmonary exercise test in ATTR-CA patients compared with non-ATTR-CA patients with HFp/mrEF iv) Comparison of 6-minute walk in ATTR-CA patients compared with non-ATTR-CA HFp/mrEF patients. v) Comparison of angiographic findings of coronary arteries in ATTR-CA patients compared with non-ATTR-CA patients with HFp/mrEF vi) Comparison of pressure data achieved by right heart catheter in ATTR-CA patients compared to non-ATTR-CA HFp/mrEF patients	—

Measure

Time frame

i) Event rate (all-cause mortality, heart failure rehospitalization, thromboembolism, and new cardiac conduction defects) within 1 year from the date of Tc-99m pyrophosphate scintigraphy in ATTR-CA patients compared to non-ATTR-CA HFp/mrEF patients. ii) Biomarker profiles (high-sensitivity troponin, NT-proBNP, creatinine, blood urea nitrogen, albumin, prealbumin, high-sensitivity C-reactive protein) and patient background factors in ATTR-CA patients compared to non-ATTR-CA patients with HFp/mrEF. iii) Comparison of exercise tolerance assessment by cardiopulmonary exercise test in ATTR-CA patients compared with non-ATTR-CA patients with HFp/mrEF iv) Comparison of 6-minute walk in ATTR-CA patients compared with non-ATTR-CA HFp/mrEF patients. v) Comparison of angiographic findings of coronary arteries in ATTR-CA patients compared with non-ATTR-CA patients with HFp/mrEF vi) Comparison of pressure data achieved by right heart catheter in ATTR-CA patients compared to non-ATTR-CA HFp/mrEF patients

—

Contacts

Public ContactYuya Matue

Juntendo University Hospital

y-matsue@juntendo.ac.jp+81-3-3813-3111

Outcome results