Actively Recruiting

Age: 60Years +
All Genders
ID04587648

Cardiac Amyloidosis in Heart Failure Patients With Preserved Ejection Fraction

Led by National Taiwan University Hospital · Updated on 2024-07-05

250

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

N

National Taiwan University Hospital

Lead Sponsor

N

National Taiwan University Hospital Jin-Shan branch

Collaborating Sponsor

AI-Summary

What this Trial Is About

Heart failure with preserved ejection fraction (HFpEF) is a complex condition that accounts for half of all heart failure cases and has various underlying causes. Diagnosing HFpEF involves recognizing heart failure symptoms, a normal left ventricular ejection fraction (LVEF), and signs of diastolic dysfunction. Recent major clinical trials have not found effective treatments for HFpEF, partly because of its diverse causes. One possible cause is wild-type transthyretin amyloidosis (ATTRwt), a condition where misfolded transthyretin protein deposits in the heart, which may be underdiagnosed in HFpEF patients, especially in Taiwan and Asia. This observational study aims to determine how common ATTRwt is among elderly HFpEF patients in Taiwan. Researchers will recruit 260 patients aged 60 or older, or 50 and older with certain risk factors like carpal tunnel syndrome or spinal stenosis. Participants will undergo heart imaging using 99mTc-PYP scintigraphy and blood tests to detect amyloid deposits. If the scan is positive, additional urine and blood tests for monoclonal light chains and genetic testing for transthyretin mutations will be performed. Existing test results from the last six months can be used to avoid repeat procedures. Participants will have routine assessments including NTproBNP blood tests, ECG, and echocardiography. Medical records will be reviewed by blinded physicians to collect clinical data. The main outcome measured is the percentage of HFpEF patients with ATTRwt in Taiwan. The study will also compare clinical and echocardiographic features between ATTRwt-positive and ATTRwt-negative patients. Participants will be involved throughout the study duration, with imaging and laboratory tests performed as part of their evaluation.

CONDITIONS

Brief Title

Cardiac Amyloidosis in HFpEF

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 60 years old or older, or 50 years old with carpal tunnel syndrome or spinal stenosis
  • Diagnosed with heart failure with preserved ejection fraction (HFpEF) or newly diagnosed with HFpEF
  • Show heart failure symptoms with New York Heart Association (NYHA) class I-IV
  • More than 50% of patients have left ventricular posterior wall thickness of 12 mm or more
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Unwilling to participate in the study
  • Unstable coronary artery disease or planning coronary intervention within months
  • History of heart failure with reduced ejection fraction (LVEF less than 40%)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and initial assessments

Diagnostic Evaluation

Duration - Up to 6 months (including use of recent test results within 6 months if available)

Participants undergo heart imaging and blood tests to detect cardiac amyloidosis, including 99mTc-PYP scintigraphy, echocardiography, ECG, and NTproBNP measurements.

1 to 2 visits depending on prior test availability

Long-term Monitoring

Duration - Ongoing after diagnostic evaluation

Participants with positive amyloidosis scans receive additional blood and genetic tests to assess disease characteristics and progression.

Additional assessments as needed depending on test results

Trial Site Locations

Total: 1 location

1

National Taiwan University Hospital

Taipei, Taiwan, 100

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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