ASIAN HF Registry, A Prospective Observational Study (ASIANHF)
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|ClinicalTrials.gov Identifier: NCT01633398|
Recruitment Status : Recruiting
First Posted : July 4, 2012
Last Update Posted : October 5, 2016
The ASIAN HF Registry is the first prospective multinational Asian registry of patients with symptomatic HF (stage C)11 including both HFrEF (ejection fraction <40%)3 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|
|Estimated Enrollment :||8000 participants|
|Official Title:||Asian Sudden Cardiac Death in Heart Failure(ASIAN-HF) Prospective Observational Study|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
- Genetic: Saliva Genetic testing
To compare the genetic variants between the two phenotypes of reduced versus preserved ejection fraction (HFrEF versus HFpEF)
- Incidence (burden) of Sudden Cardiac Deaths (SCD) in Asian patients with HF followed in a representative setting of Asian cardiology centers [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ]
The following will be estimated:
- Center-specific burden of SCD,
- Magnitude and distribution of center-specific burden of SCD, and consider relevant subgroup estimates of the burden of SCD based on relevant center characteristics.
- 0verall burden of SCD across all centers depending on the level of clinical (qualitative) and statistical (quantitative) heterogeneity.
- Risk factors for SCD among Asian patients with HF [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ]To evaluate whether risk factors for SCD identified by western studies, as well as factors peculiar to Asian patients, are associated with SCD among Asian patients with HF.
- Burden and risk factors of outcomes other than SCD (all-cause and cause-specific mortality and hospitalization) [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ]
To estimate center-specific, subgroup and overall burden of these outcomes in Asian patients with HF.
Evaluate whether relevant risk factors identified by western studies, as well as factors peculiar to Asian patients, are associated with these outcomes among Asian patients with HF.
- Sociocultural barriers to device therapy among Asian patients [ Time Frame: Baseline Visit ]We hypothesize that perceived state of health, cultural norms in ageing and ethnicity- or religion-specific health beliefs will influence receptivity to device therapy among Asian patients with HF.
- Genetic variants between the 2 phenotypes of HFrEF Vs HFpEF [ Time Frame: Baseline or any follow-up visits ]We hypothesize that an array of genetic variants will significantly segregate with HF, and subsets of variants will further differentiate HFrEF from HFpEF, as reflected among patients with the phenotypes of ejection fraction <40% (HFrEF) and ejection fraction ≥50% (HFpEF).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01633398
|Contact: Carolyn Lam, M.D.||(65) 6779 5555|
|Contact: Daniel Tan, M.D.||(65) 6779 5555|
|Zhongshan Hospital Fudan University||Recruiting|
|The Chinese University of Hong Kong||Recruiting|
|Hong Kong, Hong Kong|
|Medanta The Medicity||Recruiting|
|New Delhi, India|
|National Cardiovascular Centre Harapan Kita Hospital||Recruiting|
|Contact: Bambang Budi Siswanto, MD PhD|
|National Cerebral and Cardiovascular Center||Recruiting|
|Korea, Republic of|
|Korea University Anam Hospital||Recruiting|
|Seoul, Korea, Republic of|
|Institut Jantung Negara||Recruiting|
|Kuala Lumpur, Malaysia|
|Manila Doctors Hospital||Recruiting|
|National University Heart Center||Recruiting|
|Singapore, Singapore, 119228|
|Principal Investigator: Carolyn Lam, M.D.|
|Principal Investigator:||Carolyn Lam, M.D.||National University Heart Center (NUHC)|