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NCT04587648
Cardiac Amyloidosis in HFpEF
trial testing NA, observational study in Heart Failure With Preserved Ejection Fraction in 250 participants. Currently enrolling.
31 December 2022
Quick facts
| Lead sponsor | National Taiwan University Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 250 |
| Start date | 1 August 2019 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- NA, observational study
Conditions studied
- Heart Failure With Preserved Ejection Fraction — all drugs for Heart Failure With Preserved Ejection Fraction →
- Amyloidosis Cardiac — all drugs for Amyloidosis Cardiac →
Sponsor
National Taiwan University Hospital
Who can join
60 and older, any sex, with Heart Failure With Preserved Ejection Fraction or Amyloidosis Cardiac. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04587648
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Related trials
Other recruiting trials for Heart Failure With Preserved Ejection Fraction
Currently open trials in the same condition.
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- NCT06702501 — The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF) · NA · recruiting
- NCT06616974 — A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction · Phase 2 · recruiting
Other National Taiwan University Hospital trials
Trials by the same sponsor.
- NCT06936917 — Timing for Computed Tomography and Post-Resuscitation Care on Short-Term Outcomes in Out-of-Hospital Cardiac Arrest · not yet recruiting
- NCT05396222 — A Prospective Study of the Safety and Efficacy of 3D-printed Non-rigid Biomimetic Implant in Cervical and Thoracolumbar · NA · not yet recruiting
- NCT07532356 — Integrating Tumor Genomics and Urinary Exosomal Proteomics to Establish a Multi-Layer Biomarker Framework for Early Risk · not yet recruiting
- NCT07317310 — The NTU JO-SMART Study · NA · not yet recruiting
- NCT07382024 — Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04587648 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Taiwan University Hospital
- Last refreshed: 5 July 2024
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