Clinical trial NCT01633398: ASIAN HF Registry, A Prospective Observational Study
Official title: Asian Sudden Cardiac Death in Heart Failure(ASIAN-HF) Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
HF
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
name: Bayer
name: National Medical Research Council (NMRC), Singapore
name: Agency for Science, Technology and Research (A*STAR)
First posted: 2012-07-04
Enrollment: 6329
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility 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 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

Primary outcomes:
measure: All Cause and Cause-specific Death
timeFrame: 2 years follow up
Secondary outcomes:
measure: Sudden Cardiac Death
timeFrame: 2 years follow up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhongshan Hospital Fudan University
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
city: New Delhi
country: India
facility: Medanta The Medicity
city: Jakarta
country: Indonesia
facility: National Cardiovascular Centre Harapan Kita Hospital
city: Tokyo
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Manila
country: Philippines
facility: Manila Doctors Hospital
city: Singapore
country: Singapore
facility: National University Heart Center
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
affiliation: National University Heart Center (NUHC)
name: Carolyn Lam, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Chandramouli C, Tay WT, Bamadhaj NS, Tromp J, Teng TK, Yap JJL, MacDonald MR, Hung CL, Streng K, Naik A, Wander GS, Sawhney J, Ling LH, Richards AM, Anand I, Voors AA, Lam CSP; ASIAN-HF Investigators. Association of obesity with heart failure outcomes in 11 Asian regions: A cohort study. PLoS Med. 2019 Sep 24;16(9):e1002916. doi: 10.1371/journal.pmed.1002916. eCollection 2019 Sep.
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citation: Tromp J, Lim SL, Tay WT, Teng TK, Chandramouli C, Ouwerkerk W, Wander GS, Sawhney JPS, Yap J, MacDonald MR, Ling LH, Sattar N, McMurray JJV, Richards AM, Anand I, Lam CSP; ASIAN-HF Investigators. Microvascular Disease in Patients With Diabetes With Heart Failure and Reduced Ejection Versus Preserved Ejection Fraction. Diabetes Care. 2019 Sep;42(9):1792-1799. doi: 10.2337/dc18-2515. Epub 2019 Jul 10.
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citation: Teng TK, Tromp J, Tay WT, Anand I, Ouwerkerk W, Chopra V, Wander GS, Yap JJ, MacDonald MR, Xu CF, Chia YM, Shimizu W; ASIAN-HF investigators; Richards AM, Voors A, Lam CS. Prescribing patterns of evidence-based heart failure pharmacotherapy and outcomes in the ASIAN-HF registry: a cohort study. Lancet Glob Health. 2018 Sep;6(9):e1008-e1018. doi: 10.1016/S2214-109X(18)30306-1.
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