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ASIAN HF Registry, A Prospective Observational Study (ASIANHF)

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ClinicalTrials.gov Identifier: NCT01633398
Recruitment Status : Active, not recruiting
First Posted : July 4, 2012
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
Boston Scientific Corporation
Bayer
Translational & Clinical Research by NMRC Singapore
ATTRaCT program by A*STAR BMRC Singapore
Information provided by (Responsible Party):
Carolyn Lam, National University Health System, Singapore

Tracking Information
First Submitted Date June 27, 2012
First Posted Date July 4, 2012
Last Update Posted Date August 24, 2018
Study Start Date September 2012
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2012)
Incidence (burden) of Sudden Cardiac Deaths (SCD) in Asian patients with HF followed in a representative setting of Asian cardiology centers [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ]
The following will be estimated:
  1. Center-specific burden of SCD,
  2. Magnitude and distribution of center-specific burden of SCD, and consider relevant subgroup estimates of the burden of SCD based on relevant center characteristics.
  3. 0verall burden of SCD across all centers depending on the level of clinical (qualitative) and statistical (quantitative) heterogeneity.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01633398 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 18, 2015)
  • Risk factors for SCD among Asian patients with HF [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ]
    To evaluate whether risk factors for SCD identified by western studies, as well as factors peculiar to Asian patients, are associated with SCD among Asian patients with HF.
  • Burden and risk factors of outcomes other than SCD (all-cause and cause-specific mortality and hospitalization) [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ]
    To estimate center-specific, subgroup and overall burden of these outcomes in Asian patients with HF. Evaluate whether relevant risk factors identified by western studies, as well as factors peculiar to Asian patients, are associated with these outcomes among Asian patients with HF.
  • Sociocultural barriers to device therapy among Asian patients [ Time Frame: Baseline Visit ]
    We hypothesize that perceived state of health, cultural norms in ageing and ethnicity- or religion-specific health beliefs will influence receptivity to device therapy among Asian patients with HF.
  • Genetic variants between the 2 phenotypes of HFrEF Vs HFpEF [ Time Frame: Baseline or any follow-up visits ]
    We hypothesize that an array of genetic variants will significantly segregate with HF, and subsets of variants will further differentiate HFrEF from HFpEF, as reflected among patients with the phenotypes of ejection fraction <40% (HFrEF) and ejection fraction ≥50% (HFpEF).
Original Secondary Outcome Measures
 (submitted: June 29, 2012)
  • Risk factors for SCD among Asian patients with HF [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ]
    To evaluate whether risk factors for SCD identified by western studies, as well as factors peculiar to Asian patients, are associated with SCD among Asian patients with HF.
  • Burden and risk factors of outcomes other than SCD (all-cause and cause-specific mortality and hospitalization) [ Time Frame: Baseline Visit up to 3 years (Last Visit/Visit 5) ]
    To estimate center-specific, subgroup and overall burden of these outcomes in Asian patients with HF. Evaluate whether relevant risk factors identified by western studies, as well as factors peculiar to Asian patients, are associated with these outcomes among Asian patients with HF.
  • Sociocultural barriers to device therapy among Asian patients [ Time Frame: Baseline Visit ]
    We hypothesize that perceived state of health, cultural norms in ageing and ethnicity- or religion-specific health beliefs will influence receptivity to device therapy among Asian patients with HF.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ASIAN HF Registry, A Prospective Observational Study
Official Title Asian Sudden Cardiac Death in Heart Failure(ASIAN-HF) Prospective Observational Study
Brief Summary

The ASIAN HF Registry is the first prospective multinational Asian registry of patients with symptomatic HF (stage C)11 including both HFrEF (ejection fraction <40%)3 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.13 29 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%.3 The HFpEF population was defined according to current guidelines.29 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.29

Condition 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)
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 22, 2018)
6377
Original Estimated Enrollment
 (submitted: June 29, 2012)
5000
Estimated Study Completion Date February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China,   Hong Kong,   India,   Indonesia,   Japan,   Korea, Republic of,   Malaysia,   Philippines,   Singapore,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT01633398
Other Study ID Numbers ASIAN HF Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Carolyn Lam, National University Health System, Singapore
Study Sponsor Carolyn Lam
Collaborators
  • Boston Scientific Corporation
  • Bayer
  • 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)
PRS Account National University Health System, Singapore
Verification Date August 2018