ASIAN HF Registry, A Prospective Observational Study (ASIANHF)

July 13, 2021 updated by: Carolyn Lam

Asian Sudden Cardiac Death in Heart Failure(ASIAN-HF) Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

6329

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Zhongshan Hospital Fudan University
  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong
  • India
      • New Delhi, India
        • Medanta The Medicity
  • Indonesia
      • Jakarta, Indonesia
        • National Cardiovascular Centre Harapan Kita Hospital
  • Japan
      • Tokyo, Japan
        • National Cerebral and Cardiovascular Center
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Korea University Anam Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Institut Jantung Negara
  • Philippines
      • Manila, Philippines
        • Manila Doctors Hospital
  • Singapore
      • Singapore, Singapore, 119228
        • National University Heart center
  • Taiwan
      • Taipei, Taiwan
        • Mackay Memorial Hospital
  • Thailand
      • Bangkok, Thailand
        • Ramathibodi hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cause and Cause-specific Death
Time Frame: 2 years follow up
The incidence of all-cause and cause-specific deaths among Asian patients with HF.
2 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sudden Cardiac Death
Time Frame: 2 years follow up
The incidence of sudden cardiac death (SCD) in eligible Asian patients diagnosed with HFrEF
2 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carolyn Lam

Collaborators

Bayer
Boston Scientific Corporation
Translational & Clinical Research by NMRC Singapore
ATTRaCT program by A*STAR BMRC Singapore

Investigators

  • Principal Investigator: Carolyn Lam, M.D., National University Heart Center (NUHC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 6, 2020

Study Completion (Actual)

March 6, 2020

Study Registration Dates

First Submitted

June 27, 2012

First Submitted That Met QC Criteria

June 29, 2012

First Posted (Estimate)

July 4, 2012

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASIAN HF Registry

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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