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ASIAN HF Registry, A Prospective Observational Study

Asian Sudden Cardiac Death in Heart Failure(ASIAN-HF) Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01633398
Acronym
ASIANHF
Enrollment
6329
Registered
2012-07-04
Start date
2012-09-30
Completion date
2020-03-06
Last updated
2021-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure, HF

Brief summary

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.

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.

Interventions

GENETICSaliva Genetic testing

To compare the genetic variants between the two phenotypes of reduced versus preserved ejection fraction (HFrEF versus HFpEF)

Sponsors

Boston Scientific Corporation
CollaboratorINDUSTRY
Bayer
CollaboratorINDUSTRY
National Medical Research Council (NMRC), Singapore
CollaboratorOTHER_GOV
Agency for Science, Technology and Research (A*STAR)
CollaboratorOTHER_GOV
Carolyn Lam
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
All Cause and Cause-specific Death2 years follow upThe incidence of all-cause and cause-specific deaths among Asian patients with HF.

Secondary

MeasureTime frameDescription
Sudden Cardiac Death2 years follow upThe incidence of sudden cardiac death (SCD) in eligible Asian patients diagnosed with HFrEF

Countries

China, Hong Kong, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand

Participant flow

Participants by arm

ArmCount
HFrEF
ejection fraction \<40%
4,779
HFpEF
ejection fraction ≥50%
1,550
Total6,329

Baseline characteristics

CharacteristicHFrEFHFpEFTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
1865 Participants973 Participants2838 Participants
Age, Categorical
Between 18 and 65 years
2914 Participants577 Participants3491 Participants
NYHA Class
I/II
2752 Participants843 Participants3595 Participants
NYHA Class
III/IV
1576 Participants278 Participants1854 Participants
NYHA Class
Not assessed
451 Participants429 Participants880 Participants
Race/Ethnicity, Customized
Chinese
1242 Participants726 Participants1968 Participants
Race/Ethnicity, Customized
Indian
1591 Participants517 Participants2108 Participants
Race/Ethnicity, Customized
Malay
657 Participants95 Participants752 Participants
Race/Ethnicity, Customized
NA
2 Participants3 Participants5 Participants
Race/Ethnicity, Customized
Others
1287 Participants209 Participants1496 Participants
Sex: Female, Male
Female
1089 Participants762 Participants1851 Participants
Sex: Female, Male
Male
3690 Participants788 Participants4478 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
500 / 4,73760 / 1,114
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
500 / 4,73760 / 1,114

Outcome results

Primary

All Cause and Cause-specific Death

The incidence of all-cause and cause-specific deaths among Asian patients with HF.

Time frame: 2 years follow up

Population: Patients with outcomes available at 1 year were examined for all-cause and cardiovascular (CV) death. Patients who were lost to follow-up were excluded from the analysis.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
HFrEFAll Cause and Cause-specific DeathAll-cause mortality500 Participants
HFrEFAll Cause and Cause-specific DeathCV mortality270 Participants
HFpEFAll Cause and Cause-specific DeathAll-cause mortality60 Participants
HFpEFAll Cause and Cause-specific DeathCV mortality32 Participants
Secondary

Sudden Cardiac Death

The incidence of sudden cardiac death (SCD) in eligible Asian patients diagnosed with HFrEF

Time frame: 2 years follow up

Population: ESC guidelines recommend an implantable cardioverter-defibrillator (ICD) device for primary prevention in symptomatic patients with heart failure with reduced ejection fraction (HFrEF), provided they are expected to survive substantially longer than one year with good functional status.~For this outcome measure, only HFrEF patients who were eligible for ICD devices were included; HFpEF patients were excluded.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
HFrEFSudden Cardiac Death109 Participants
HFpEFSudden Cardiac Death0 Participants

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026