An observational study in Heart Failure, sponsored by Carolyn Lam. Completed at 11 sites in 11 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by Carolyn Lam · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 6,329 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Carolyn Lam as lead sponsor.
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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.
Exclusion Criteria:
To compare the genetic variants between the two phenotypes of reduced versus preserved ejection fraction (HFrEF versus HFpEF)
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
Sudden Cardiac Death
The incidence of sudden cardiac death (SCD) in eligible Asian patients diagnosed with HFrEF
Time frame: 2 years follow up
| Milestone | HFrEF | HFpEF |
|---|---|---|
| Started | 4779 | 1550 |
| Completed | 4779 | 1550 |
| Not completed | 0 | 0 |
The incidence of all-cause and cause-specific deaths among Asian patients with HF.
| Participants | HFrEF | HFpEF |
|---|---|---|
| All-cause mortality | 500 | 60 |
| CV mortality | 270 | 32 |
The incidence of sudden cardiac death (SCD) in eligible Asian patients diagnosed with HFrEF
| Participants | HFrEF | HFpEF |
|---|---|---|
| Sudden Cardiac Death | 109 | 0 |
Collected over 2 years follow up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HFrEF | 500/4,737 (10.6%) | 500/4,737 (10.6%) | — |
| HFpEF | 60/1,114 (5.4%) | 60/1,114 (5.4%) | — |
| Event | HFrEF | HFpEF |
|---|---|---|
| DeathCardiac disorders | 500/4737 | 60/1114 |
| Age, Categorical(Participants) | HFrEF | HFpEF | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2914 | 577 | 3491 |
| >=65 years | 1865 | 973 | 2838 |
| Sex: Female, Male(Participants) | HFrEF | HFpEF | Total |
|---|---|---|---|
| Female | 1089 | 762 | 1851 |
| Male | 3690 | 788 | 4478 |
| Race/Ethnicity, Customized(Participants) | HFrEF | HFpEF | Total |
|---|---|---|---|
| Chinese | 1242 | 726 | 1968 |
| Indian | 1591 | 517 | 2108 |
| Malay | 657 | 95 | 752 |
| Others | 1287 | 209 | 1496 |
| NA | 2 | 3 | 5 |
| NYHA Class(Participants) | HFrEF | HFpEF | Total |
|---|---|---|---|
| I/II | 2752 | 843 | 3595 |
| III/IV | 1576 | 278 | 1854 |
| Not assessed | 451 | 429 | 880 |
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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