Heart Failure
Conditions
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
To compare the genetic variants between the two phenotypes of reduced versus preserved ejection fraction (HFrEF versus HFpEF)
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| All Cause and Cause-specific Death | 2 years follow up | The incidence of all-cause and cause-specific deaths among Asian patients with HF. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sudden Cardiac Death | 2 years follow up | The 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
| Arm | Count |
|---|---|
| HFrEF ejection fraction \<40% | 4,779 |
| HFpEF ejection fraction ≥50% | 1,550 |
| Total | 6,329 |
Baseline characteristics
| Characteristic | HFrEF | HFpEF | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1865 Participants | 973 Participants | 2838 Participants |
| Age, Categorical Between 18 and 65 years | 2914 Participants | 577 Participants | 3491 Participants |
| NYHA Class I/II | 2752 Participants | 843 Participants | 3595 Participants |
| NYHA Class III/IV | 1576 Participants | 278 Participants | 1854 Participants |
| NYHA Class Not assessed | 451 Participants | 429 Participants | 880 Participants |
| Race/Ethnicity, Customized Chinese | 1242 Participants | 726 Participants | 1968 Participants |
| Race/Ethnicity, Customized Indian | 1591 Participants | 517 Participants | 2108 Participants |
| Race/Ethnicity, Customized Malay | 657 Participants | 95 Participants | 752 Participants |
| Race/Ethnicity, Customized NA | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Others | 1287 Participants | 209 Participants | 1496 Participants |
| Sex: Female, Male Female | 1089 Participants | 762 Participants | 1851 Participants |
| Sex: Female, Male Male | 3690 Participants | 788 Participants | 4478 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 500 / 4,737 | 60 / 1,114 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 500 / 4,737 | 60 / 1,114 |
Outcome results
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HFrEF | All Cause and Cause-specific Death | All-cause mortality | 500 Participants |
| HFrEF | All Cause and Cause-specific Death | CV mortality | 270 Participants |
| HFpEF | All Cause and Cause-specific Death | All-cause mortality | 60 Participants |
| HFpEF | All Cause and Cause-specific Death | CV mortality | 32 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HFrEF | Sudden Cardiac Death | 109 Participants |
| HFpEF | Sudden Cardiac Death | 0 Participants |