ASIAN HF Registry, A Prospective Observational Study (ASIANHF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by National University Health System, Singapore
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
National University Health System, Singapore
ClinicalTrials.gov Identifier:
NCT01633398
First received: June 27, 2012
Last updated: October 4, 2012
Last verified: October 2012
  Purpose

The ASIAN HF Registry is the first prospective multinational Asian registry of patients with symptomatic HF (stage C)11 and left ventricular systolic dysfunction (ejection fraction < 40%3), 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.

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
Heart Failure

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.


Estimated Enrollment: 5000
Study Start Date: September 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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 40 top medical centers across 10 Asian regions (Korea, Thailand, Indonesia, Philippines, India, Japan, Malaysia, Hong Kong, China, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 and left ventricular systolic dysfunction (ejection fraction < 40%). The inclusion criteria were selected in recognition of current recommendations emphasizing that HF is a progressive, staged disease; in acknowledgement of the subjective nature of NYHA functional classification; and is also supported by a recent meta-analysis showing that risk of death in HF increases as ejection fraction falls below 40%.

Criteria

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 systolic dysfunction (ejection fraction <40% on baseline echocardiography)
  4. Available for follow-up over 3 years

Exclusion Criteria:

  1. Severe valve disease as the primary cause of HF
  2. Life threatening co-morbidity with life expectancy of <1 year
  3. Unable or unwilling to give consent
  4. 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 ClinicalTrials.gov identifier: NCT01633398

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

Locations
China
Not yet recruiting
Beijing, China
Hong Kong
Not yet recruiting
Hong Kong, Hong Kong
India
Not yet recruiting
New Delhi, India
Indonesia
Not yet recruiting
Jakarta, Indonesia
Japan
Not yet recruiting
Tokyo, Japan
Korea, Republic of
Not yet recruiting
Seoul, Korea, Republic of
Malaysia
Not yet recruiting
Kuala Lumpur, Malaysia
Philippines
Not yet recruiting
Manila, Philippines
Singapore
Recruiting
Singapore, Singapore
Principal Investigator: Carolyn Lam, M.D.         
Thailand
Not yet recruiting
Bangkok, Thailand
Sponsors and Collaborators
National University Health System, Singapore
Boston Scientific Corporation
Investigators
Principal Investigator: Carolyn Lam, M.D. National University Heart Center (NUHC)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National University Health System, Singapore
ClinicalTrials.gov Identifier: NCT01633398     History of Changes
Other Study ID Numbers: ASIAN HF Registry
Study First Received: June 27, 2012
Last Updated: October 4, 2012
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

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014