ASIAN HF Registry, A Prospective Observational Study

Completed

Conditions: Heart Failure

Registration Number: NCT01633398

Lead Sponsor: Carolyn Lam

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 6329

Inclusion Criteria

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

Exclusion Criteria

Severe valve disease as the primary cause of HF
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.
Life threatening co-morbidity with life expectancy of <1 year
Unable or unwilling to give consent
Concurrent participation in a clinical therapeutic trial which requires patient consent

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Sudden Cardiac Death	2 years follow up	The incidence of sudden cardiac death (SCD) in eligible Asian patients diagnosed with HFrEF

Trial Locations

Locations (11): Korea University Anam Hospital
🇰🇷
Seoul, Korea, Republic of
Medanta The Medicity
🇮🇳
New Delhi, India
National Cardiovascular Centre Harapan Kita Hospital
🇮🇩
Jakarta, Indonesia
National Cerebral and Cardiovascular Center
🇯🇵
Tokyo, Japan
National University Heart Center
🇸🇬
Singapore, Singapore
Manila Doctors Hospital
🇵🇭
Manila, Philippines
Mackay Memorial Hospital
🇨🇳
Taipei, Taiwan
Ramathibodi Hospital
🇹🇭
Bangkok, Thailand
Zhongshan Hospital Fudan University
🇨🇳
Beijing, China
Institut Jantung Negara
🇲🇾
Kuala Lumpur, Malaysia
The Chinese University of Hong Kong
🇭🇰
Hong Kong, Hong Kong