ASIAN HF Registry, A Prospective Observational Study (ASIANHF)
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|ClinicalTrials.gov Identifier: NCT01633398|
Recruitment Status : Completed
First Posted : July 4, 2012
Results First Posted : July 14, 2021
Last Update Posted : July 14, 2021
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The ASIAN HF Registry is the first prospective multinational Asian registry of patients with symptomatic HF (stage C) including both HFrEF (ejection fraction <40%) and HFpEF (ejection fraction ≥50%), with the broad purpose of determining the mortality (incidence) burden of HF in Asian patients, and more specifically to define the burden and risk factors of Sudden Cardiac Deaths (SCD), as well as the sociocultural barriers to preventive device therapy. The study further aim to study the genetic variants associated with HFrEF versus HFpEF in our large Asian cohort.
This proposed registry is expected to advance fundamental understanding of the burden and predictors of preventable death among Asian patients with HF. The knowledge gained will be critical for guiding resource allocation and planning preventive strategies to address the unmet and growing clinical needs of patients with cardiovascular disease in Asia.
|Condition or disease||Intervention/treatment|
|Heart Failure||Genetic: Saliva Genetic testing|
Heart failure (HF) is a major public health problem worldwide. As the final common pathway of a myriad of heart diseases, HF burden increases with increasing prevalence of cardiovascular disease in a community, as patients survive their acute cardiac conditions (such as heart attacks) and progress to chronic HF. Further, HF is a debilitating and deadly condition with high rehospitalization rates and dismal survival rates comparable to most cancers. In Singapore alone, the age-adjusted HF admission rate rose by ~40% over the last decade,1 making HF the commonest cardiac cause of hospitalization (representing ~24% of all cardiac admissions), and the 5-year survival rate in patients with HF is only 32%. These alarming statistics reflect the global shift in cardiovascular disease burden to developing countries in Asia. In fact, the World Health Organization has projected that the largest increases in cardiovascular disease worldwide are occurring in Asia, due to rapidly increasing rates of smoking, obesity, dyslipidemia and diabetes among Asians. Thus the burden of HF is expected to reach epidemic proportions in Asia. Yet in sharp contrast to the wealth of data regarding HF in Western nations, epidemiologic data are scarce in Asian patients with HF.
The study will involve 46 top medical centers across 11 Asian regions (Korea, Thailand, Indonesia, Philippines, India, Japan, Malaysia, Hong Kong, China, Taiwan and Singapore). Site selection targeted a mix of centers covering a broad spectrum of medical, cardiology and HF specialty units regularly admitting patients with acute HF and following outpatients with chronic HF, constituting a novel network of Asian centers of cardiovascular expertise.
Data collection will include demographic variables, clinical symptoms, functional status, date of HF diagnosis and prior cardiovascular investigations, clinical risk factors, lifestyle factors, socioeconomic status, and survey of cultural beliefs, health practices and attitudes towards device therapy. Center-level characteristics (caseload, referral pattern, specialization, infrastructure) will also be obtained. Patients will undergo standard 12-lead electrocardiography and transthoracic echocardiography at baseline, and followed over 3 years for outcomes of death or hospitalization. Each outcome event and its cause will be adjudicated by a central committee using pre-specified criteria.
|Study Type :||Observational|
|Actual Enrollment :||6329 participants|
|Official Title:||Asian Sudden Cardiac Death in Heart Failure(ASIAN-HF) Prospective Observational Study|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 6, 2020|
|Actual Study Completion Date :||March 6, 2020|
- Genetic: Saliva Genetic testing
To compare the genetic variants between the two phenotypes of reduced versus preserved ejection fraction (HFrEF versus HFpEF)
- All Cause and Cause-specific Death [ Time Frame: 2 years follow up ]The incidence of all-cause and cause-specific deaths among Asian patients with HF.
- Sudden Cardiac Death [ Time Frame: 2 years follow up ]The incidence of sudden cardiac death (SCD) in eligible Asian patients diagnosed with HFrEF
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|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
This is a prospective, observational, multinational, multicenter Asian registry of patients with Stage C HF, including both HFrEF (ejection fraction <40%) and HFpEF (ejection fraction ≥50%).
This study population (Stage C HF) was selected in recognition of current recommendations emphasizing that HF is a progressive, staged disease.The HFrEF population was defined based on a recent meta-analysis showing that risk of death in HF increases particularly as ejection fraction falls below 40%. The HFpEF population was defined according to current guidelines. Patients with an ejection fraction in the range of 40% to 50% represent an intermediate group which was not included since we aimed to study distinct clinical phenotypes.
- Adults (>18 years)
- Symptomatic HF (Stage C HF regardless of functional status). Patients should have a current diagnosis of symptomatic HF within 6 months of an episode of decompensated heart failure*, which either: (a) resulted in a hospital admission (primary diagnosis) or b) was treated in out-patient clinic
- Left ventricular ejection fraction <40% (HFrEF) or left ventricular ejection fraction ≥50% (HFpEF) on baseline echocardiography
- Available for follow-up over 3 years
- Severe valve disease as the primary cause of HF
- For the HFpEF population: a documented history of reduced ejection fraction (<50%) at any time prior to recruitment, In other words, patients with current HFpEF who previously had HFrEF will be excluded.
- Life threatening co-morbidity with life expectancy of <1 year
- Unable or unwilling to give consent
- Concurrent participation in a clinical therapeutic trial which requires patient consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633398
|Zhongshan Hospital Fudan University|
|The Chinese University of Hong Kong|
|Hong Kong, Hong Kong|
|Medanta The Medicity|
|New Delhi, India|
|National Cardiovascular Centre Harapan Kita Hospital|
|National Cerebral and Cardiovascular Center|
|Korea, Republic of|
|Korea University Anam Hospital|
|Seoul, Korea, Republic of|
|Institut Jantung Negara|
|Kuala Lumpur, Malaysia|
|Manila Doctors Hospital|
|National University Heart Center|
|Singapore, Singapore, 119228|
|Mackay Memorial Hospital|
|Principal Investigator:||Carolyn Lam, M.D.||National University Heart Center (NUHC)|
Documents provided by Carolyn Lam, National University Health System, Singapore:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Carolyn Lam, Senior Consultant, National Heart Centre Singapore and Professor, Duke-National University of Singapore, National University Health System, Singapore|
|Other Study ID Numbers:||
ASIAN HF Registry
|First Posted:||July 4, 2012 Key Record Dates|
|Results First Posted:||July 14, 2021|
|Last Update Posted:||July 14, 2021|
|Last Verified:||July 2021|