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Heart FailureASIANHFNCT01633398

ASIAN HF Registry, A Prospective Observational Study

An observational study of Heart Failure, run by Carolyn Lam at 11 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Heart Failure
What is being tested?
Saliva Genetic testing
How many people
6,329 participants
Where
11 sitesin 11 countries
Study dates
Sep 2012to 6 Mar 2020
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 11 countries.

11 sites in 11 countries

China1 site
  • Zhongshan Hospital Fudan University

    Beijing

Other trials in China

Hong Kong1 site
  • The Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

India1 site
  • Medanta The Medicity

    New Delhi

Other trials in India

Indonesia1 site
  • National Cardiovascular Centre Harapan Kita Hospital

    Jakarta

Other trials in Indonesia

Japan1 site
  • National Cerebral and Cardiovascular Center

    Tokyo

Other trials in Japan

Malaysia1 site
  • Institut Jantung Negara

    Kuala Lumpur

Other trials in Malaysia

Philippines1 site
  • Manila Doctors Hospital

    Manila

Other trials in Philippines

Singapore1 site
  • National University Heart Center

    Singapore, 119228

Other trials in Singapore

South Korea1 site
  • Korea University Anam Hospital

    Seoul

Other trials in South Korea

Taiwan1 site
  • Mackay Memorial Hospital

    Taipei

Other trials in Taiwan

Thailand1 site
  • Ramathibodi Hospital

    Bangkok

Other trials in Thailand

About this study

Official title: 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.

Read the 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
Being tested
Saliva Genetic testing
Keywords
Heart Failure, HF
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Saliva Genetic testingGenetic

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All Cause and Cause-specific Death

    The incidence of all-cause and cause-specific deaths among Asian patients with HF.

    Measured: 2 years follow up

Secondary outcomes (1)
  1. Sudden Cardiac Death

    The incidence of sudden cardiac death (SCD) in eligible Asian patients diagnosed with HFrEF

    Measured: 2 years follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2012 (estimated)
  2. Study startSep 2012
  3. Primary completion6 Mar 2020
  4. Study completion6 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
6,329 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01633398
Sponsor's protocol ID
ASIAN HF Registry
Acronym
ASIANHF
Status last verified
Jul 2021
First submitted
27 Jun 2012
Last updated
14 Jul 2021
Data monitoring committee
No

Publications

  • Ng TP, Niti M. Trends and ethnic differences in hospital admissions and mortality for congestive heart failure in the elderly in Singapore, 1991 to 1998. Heart. 2003 Aug;89(8):865-70. doi: 10.1136/heart.89.8.865.

    PubMed 12860859
  • Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW; American College of Cardiology Foundation; American Heart Association. 2009 Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the International Society for Heart and Lung Transplantation. J Am Coll Cardiol. 2009 Apr 14;53(15):e1-e90. doi: 10.1016/j.jacc.2008.11.013. No abstract available.

    PubMed 19358937
  • Teng TK, Lam CSP; ASIAN-HF Executive Committee and Investigators. Comprehensive Introduction to ASIAN-HF Registry. JACC Asia. 2025 Sep;5(9):1206-1216. doi: 10.1016/j.jacasi.2025.05.020. Epub 2025 Jul 29.

    PubMed 40736437
  • Aung T, Qin Y, Tay WT, Binte Salahudin Bamadhaj NS, Chandramouli C, Ouwerkerk W, Tromp J, Anand I, Richards AM, Hung CL, Teramoto K, Katherine Teng TH, Lam CSP. Prevalence and Prognostic Significance of Frailty in Asian Patients With Heart Failure: Insights From ASIAN-HF. JACC Asia. 2021 Dec 7;1(3):303-313. doi: 10.1016/j.jacasi.2021.09.006. eCollection 2021 Dec.

    PubMed 36341220
  • Tay WT, Teng TK, Simon O, Ouwerkerk W, Tromp J, Doughty RN, Richards AM, Hung CL, Qin Y, Aung T, Anand I, Lam CSP; ASIAN-HF Investigators. Readmissions, Death and Its Associated Predictors in Heart Failure With Preserved Versus Reduced Ejection Fraction. J Am Heart Assoc. 2021 Nov 16;10(22):e021414. doi: 10.1161/JAHA.121.021414. Epub 2021 Oct 20.

    PubMed 34666509
  • Teng TK, Tay WT, Richards AM, Chew TSM, Anand I, Ouwerkerk W, Chandramouli C, Huang W, Lawson CA, Kadam UT, Yap J, Lim S, Hung CL, MacDonald MR, Loh SY, Shimizu W, Tromp J, Lam CSP; ASIAN-HF investigatorsdouble dagger. Socioeconomic Status and Outcomes in Heart Failure With Reduced Ejection Fraction From Asia. Circ Cardiovasc Qual Outcomes. 2021 Apr;14(4):e006962. doi: 10.1161/CIRCOUTCOMES.120.006962. Epub 2021 Mar 24.

    PubMed 33757307
  • Chyou JY, Tay WT, Anand IS, Teng TK, Yap JJL, MacDonald MR, Chopra V, Loh SY, Shimizu W, Abidin IZ; ASIAN-HF Investigators; Richards AM, Butler J, Lam CSP. Electroanatomic Ratios and Mortality in Patients With Heart Failure: Insights from the ASIAN-HF Registry. J Am Heart Assoc. 2021 Mar 16;10(6):e017932. doi: 10.1161/JAHA.120.017932. Epub 2021 Mar 13.

    PubMed 33719492
  • Huang W, Teng TK, Tay WT, Richards AM, Kadam U, Lawson CA, Shimizu W, Loh SY, Anand I, Lam CSP. Patient-reported outcomes in heart failure with preserved vs. reduced ejection fraction: focus on physical independence. ESC Heart Fail. 2020 Oct;7(5):2051-2062. doi: 10.1002/ehf2.12950. Epub 2020 Aug 30.

    PubMed 32862518
  • MacDonald MR, Tay WT, Teng TK, Anand I, Ling LH, Yap J, Tromp J, Wander GS, Naik A, Ngarmukos T, Siswanto BB, Hung CL, Richards AM, Lam CSP; ASIAN-F investigators dagger; ASIAN-F investigators<xref ref-type="author-note" rid="jah34461-note-1001"><sup>dagger</sup></xref>. Regional Variation of Mortality in Heart Failure With Reduced and Preserved Ejection Fraction Across Asia: Outcomes in the ASIAN-HF Registry. J Am Heart Assoc. 2020 Jan 7;9(1):e012199. doi: 10.1161/JAHA.119.012199. Epub 2019 Dec 19.

    PubMed 31852421
  • 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.

    PubMed 31550265
  • Yap J, Tay WT, Teng TK, Anand I, Richards AM, Ling LH, MacDonald MR, Chandramouli C, Tromp J, Siswanto BB; ASIAN-HF (Asian Sudden Cardiac Death in Heart Failure) Registry Investigators; Zile M, McMurray J, Lam CSP. Association of Diabetes Mellitus on Cardiac Remodeling, Quality of Life, and Clinical Outcomes in Heart Failure With Reduced and Preserved Ejection Fraction. J Am Heart Assoc. 2019 Sep 3;8(17):e013114. doi: 10.1161/JAHA.119.013114. Epub 2019 Aug 21.

    PubMed 31431116
  • 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.

    PubMed 31292141
  • Chandramouli C, Teng TK, Tay WT, Yap J, MacDonald MR, Tromp J, Yan L, Siswanto B, Reyes EB, Ngarmukos T, Yu CM, Hung CL, Anand I, Richards AM, Ling LH, Regensteiner JG, Lam CSP; ASIAN-HF Investigators. Impact of diabetes and sex in heart failure with reduced ejection fraction patients from the ASIAN-HF registry. Eur J Heart Fail. 2019 Mar;21(3):297-307. doi: 10.1002/ejhf.1358. Epub 2018 Dec 10.

    PubMed 30548089
  • 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.

    PubMed 30103979
  • Tromp J, Tay WT, Ouwerkerk W, Teng TK, Yap J, MacDonald MR, Leineweber K, McMurray JJV, Zile MR, Anand IS, Richards AMR, Lam CSP; ASIAN-HF authors. Multimorbidity in patients with heart failure from 11 Asian regions: A prospective cohort study using the ASIAN-HF registry. PLoS Med. 2018 Mar 27;15(3):e1002541. doi: 10.1371/journal.pmed.1002541. eCollection 2018 Mar.

    PubMed 29584721

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Carolyn Lam at 11 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in China, Hong Kong, India, Indonesia, Japan and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cause and Cause-specific Death (time frame: 2 years follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01633398, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.

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ASIAN HF Registry, A Prospective Observational Study | AzTrials