Cardiac Amyloidosis in HFpEF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorNational Taiwan University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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%.
Trial population
Eligible HFpEF patients with a LVEF ≥50%, NYHA class I-IV symptoms: Both in-patients or patients in clinics could be enrolled. These patients could be newly diagnosed or has been diagnosed. Study subjects will be pre-stratified according to left ventricular posterior wall thickness (LVPW) ≥12mm or less; number of subjects with LVPW ≥12mm should account for more than 50% of total subjects recruited in the final analysis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NA, observational study
Other interventionNA, observational study
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Prevalence of ATTRwt among patients with HFpEF in Taiwan
Time frame
At enrollmentSponsors and contacts
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National Taiwan University Hospital
Lead sponsor
National Taiwan University Hospital Jin-Shan branch
Collaborator
National Taiwan University Hospital Hsin-Chu Branch
Collaborator
Source ClinicalTrials.gov