ASIAN HF Registry, A Prospective Observational Study

Heart Failure Clinical Trial

— ASIANHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633398
• Other study ID #: ASIAN HF Registry
• Status: Completed
• Start date: September 2012
• Est. completion date: March 6, 2020

Study information

• Verified date: July 2021
• Source: National University Health System, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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 information / eligibility

• Status: Completed
• Enrollment: 6329
• Est. completion date: March 6, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Genetic:
• Saliva Genetic testing
To compare the genetic variants between the two phenotypes of reduced versus preserved ejection fraction (HFrEF versus HFpEF)

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Carolyn Lam	ATTRaCT program by A*STAR BMRC Singapore, Bayer, Boston Scientific Corporation, Translational & Clinical Research by NMRC Singapore

Countries where clinical trial is conducted

China,  Hong Kong,  India,  Indonesia,  Japan,  Korea, Republic of,  Malaysia,  Philippines,  Singapore,  Taiwan,  Thailand, 

References & Publications (2)

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. Erratum in: J Am Coll Cardiol. 2009 Dec 15;54(25):2464. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause and Cause-specific Death	The incidence of all-cause and cause-specific deaths among Asian patients with HF.	2 years follow up
Secondary	Sudden Cardiac Death	The incidence of sudden cardiac death (SCD) in eligible Asian patients diagnosed with HFrEF	2 years follow up