ASIAN HF Registry, A Prospective Observational Study

NCT ID: NCT01633398

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6329 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2020-03-06

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Saliva Genetic testing

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

Intervention Type: GENETIC

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role: collaborator

Agency for Science, Technology and Research (A*STAR)

OTHER_GOV

Sponsor Role: collaborator

Carolyn Lam

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Lam

Senior Consultant, National Heart Centre Singapore and Professor, Duke-National University of Singapore

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carolyn Lam, M.D.

Role: PRINCIPAL_INVESTIGATOR

National University Heart Center (NUHC)

Locations

Zhongshan Hospital Fudan University

Beijing, , China

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Medanta The Medicity

New Delhi, , India

National Cardiovascular Centre Harapan Kita Hospital

Jakarta, , Indonesia

National Cerebral and Cardiovascular Center

Tokyo, , Japan

Institut Jantung Negara

Kuala Lumpur, , Malaysia

Manila Doctors Hospital

Manila, , Philippines

National University Heart Center

Singapore, , Singapore

Korea University Anam Hospital

Seoul, , South Korea

Mackay Memorial Hospital

Taipei, , Taiwan

Ramathibodi Hospital

Bangkok, , Thailand

Countries

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

References

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Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

ASIAN HF Registry

Identifier Type: -

Identifier Source: org_study_id