N/A
Completed N=6,329
ASIAN HF Registry, A Prospective Observational Study
Source: ClinicalTrials.gov NCT01633398 ↗Enrolled (actual)
6,329
Serious AEs
9.6%
Results posted
Jul 2021
Primary outcomePrimary: All Cause and Cause-specific Death — 500; 60; 270; 32 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All Cause and Cause-specific Death |
500; 60; 270; 32 | — |
| SECONDARY Sudden Cardiac Death |
109; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01633398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.