| NCT ID | NCT04587648 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Taiwan University Hospital |
| Condition | Heart Failure With Preserved Ejection Fraction |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2019-08-01 |
| Primary Completion | 2022-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2019-08-01 with a primary completion date of 2022-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Heart failure with preserved ejection fraction (HFpEF) accounts for half of heart failure cases with heterogenous cause and variable presentations. The diagnosis of HFpEF required clinical signs and symptoms of HF, normal left ventricular ejection fraction (LVEF) and evidence of diastolic dysfunction. No treatment has been shown in recent major clinical trials having benefits in these patients. One major reason of the poor response to medical treatment is the heterogeneity of HFpEF, which contains many different underline causes. To identify the underlying causes of HFpEF may improve the diagnosis and treatment in these patients. Age-related amyloid deposition has first been reported in 1876 and the following autopsy studies showed the prevalence of senile cardiac amyloid is up to 25%. Recently, it has been recognized that the deposits in senile cardiac amyloid are derived from wild-type transthyretin (TTR). Transthyretin amyloidosis cardiac amyloidosis (ATTR CA) is caused by myocardial deposition of misfolded transthyretin protein. There are 2 types of ATTR classified by genetic mutation including wild-type ATTR (ATTRwt) and familial cardiac amyloid caused by TTR mutation (ATTRm). Multimodality techniques have been developed to assist in the diagnosis of the diagnosis of TTR. Among them, 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (99mTc-DPD) scintigraphy is a non-invasive test and it can diagnose TTR from other cause diverse form of cardiac amyloidosis and cardiomyopathy. In the study of Gonzalez-Lopez et al, in 120 HFpEF patients, 16 (13.3%) had positive 99mTc-DPD scan. Four patients with positive 99mTc-DPD scan received endomyocardial biopsy and confirmed cardiac amyloid deposition. ATTRwt could be an important cause of HFpEF and it was often under diagnosed. A recent study in Spain reported that 13% of patents over age of 60 years with HFpEF and left ventricular wall thickness of 12mm or more had ATTRwt. However, the prevalence of ATTRwt among patients with HFpEF is not well-established in Taiwan and Asia. The aim of this study is to determine the prevalence, clinical characteristics, risk factors and outcomes of ATTRwt related HFpEF patients in Taiwan.
Eligibility Criteria
Inclusion Criteria: * Patient is ≥ 60 years old or 50 y/o with carpal tunnel syndrome or spinal stenosis * Patient has been diagnosed as HFpEF in their medical history or newly diagnosed as HFpEF. They have HF symptoms with NYHA Classification of I-IV when diagnosis. The criteria of HFpEF is according to our previous studies. * More than 50% of them have LVPW ≥12mm (when diagnosis). * Written informed consent could be obtained. Exclusion Criteria: * Patients unwilling to join this projects. * Patients with unstable coronary artery disease, plan to receive coronary intervention within months. * Patients has previous history of HFrEF with a LVEF \<40%.
Frequently Asked Questions
Who can join the NCT04587648 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Heart Failure With Preserved Ejection Fraction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04587648 currently recruiting?
Yes, NCT04587648 is actively recruiting participants. Visit ClinicalTrials.gov or contact National Taiwan University Hospital to inquire about joining.
Where is the NCT04587648 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT04587648 clinical trial?
NCT04587648 is sponsored by National Taiwan University Hospital. The trial plans to enroll 250 participants.
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