ASIAN HF Registry, A Prospective Observational Study (ASIANHF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by National University Health System, Singapore
Boston Scientific Corporation
Information provided by (Responsible Party):
Carolyn Lam, National University Health System, Singapore Identifier:
First received: June 27, 2012
Last updated: October 18, 2015
Last verified: October 2015

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 Intervention
Heart Failure
Genetic: Saliva Genetic testing

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Asian Sudden Cardiac Death in Heart Failure(ASIAN-HF) Prospective Observational Study

Resource links provided by NLM:

Further study details as provided by National University Health System, Singapore:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    The following will be estimated:

    1. Center-specific burden of SCD,
    2. Magnitude and distribution of center-specific burden of SCD, and consider relevant subgroup estimates of the burden of SCD based on relevant center characteristics.
    3. 0verall burden of SCD across all centers depending on the level of clinical (qualitative) and statistical (quantitative) heterogeneity.

Secondary Outcome Measures:
  • Risk factors for SCD among Asian patients with HF [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).

Estimated Enrollment: 8000
Study Start Date: September 2012
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Genetic: Saliva Genetic testing
    To compare the genetic variants between the two phenotypes of reduced versus preserved ejection fraction (HFrEF versus HFpEF)
Detailed Description:

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.


Ages Eligible for Study:   18 Years to 100 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.13 29 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%.3 The HFpEF population was defined according to current guidelines.29 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.29


Inclusion Criteria:

  1. Adults (>18 years)
  2. 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
  3. Left ventricular ejection fraction <40% (HFrEF) or left ventricular ejection fraction ≥50% (HFpEF) on baseline echocardiography
  4. Available for follow-up over 3 years

Exclusion Criteria:

  1. Severe valve disease as the primary cause of HF
  2. 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.
  3. Life threatening co-morbidity with life expectancy of <1 year
  4. Unable or unwilling to give consent
  5. Concurrent participation in a clinical therapeutic trial which requires patient consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01633398

Contact: Carolyn Lam, M.D. (65) 6779 5555
Contact: Daniel Tan, M.D. (65) 6779 5555

Zhongshan Hospital Fudan University Recruiting
Beijing, China
Hong Kong
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
Jakarta, Indonesia
Contact: Bambang Budi Siswanto, MD PhD         
National Cerebral and Cardiovascular Center Recruiting
Tokyo, Japan
Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Institut Jantung Negara Recruiting
Kuala Lumpur, Malaysia
Manila Doctors Hospital Recruiting
Manila, Philippines
National University Heart Center Recruiting
Singapore, Singapore, 119228
Principal Investigator: Carolyn Lam, M.D.         
Ramathibodi Hospital Recruiting
Bangkok, Thailand
Sponsors and Collaborators
Carolyn Lam
Boston Scientific Corporation
Principal Investigator: Carolyn Lam, M.D. National University Heart Center (NUHC)
  More Information

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Carolyn Lam, Consultant - Department of Cardiology NUHSC, National University Health System, Singapore Identifier: NCT01633398     History of Changes
Other Study ID Numbers: ASIAN HF Registry
Study First Received: June 27, 2012
Last Updated: October 18, 2015
Health Authority: China: Food and Drug Administration
Hong Kong: Department of Health
India: Drugs Controller General of India
India: Institutional Review Board
Indonesia: National Agency of Drug and Food Control
Japan: Pharmaceuticals and Medical Devices Agency
Malaysia: Institutional Review Board
Philippines: Bureau of Food and Drugs
Singapore: Health Sciences Authority
Singapore: Domain Specific Review Boards
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Thailand: Food and Drug Administration
Thailand: Ethical Committee
Taiwan:Taiwan Food and Drug Administration

Keywords provided by National University Health System, Singapore:
Heart Failure

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on November 27, 2015