Trial Outcomes & Findings for ASIAN HF Registry, A Prospective Observational Study (NCT NCT01633398)

NCT ID: NCT01633398

Last Updated: 2021-07-14

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 6329 participants
• Primary outcome timeframe: 2 years follow up
• Results posted on: 2021-07-14

Participant Flow

Participant milestones

Measure	HFrEF ejection fraction \<40%	HFpEF ejection fraction ≥50%
Overall Study STARTED	4779	1550
Overall Study COMPLETED	4779	1550
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ASIAN HF Registry, A Prospective Observational Study

Baseline characteristics by cohort

Measure	HFrEF n=4779 Participants ejection fraction \<40%	HFpEF n=1550 Participants ejection fraction ≥50%	Total n=6329 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2914 Participants n=5 Participants	577 Participants n=7 Participants	3491 Participants n=5 Participants
Age, Categorical >=65 years	1865 Participants n=5 Participants	973 Participants n=7 Participants	2838 Participants n=5 Participants
Sex: Female, Male Female	1089 Participants n=5 Participants	762 Participants n=7 Participants	1851 Participants n=5 Participants
Sex: Female, Male Male	3690 Participants n=5 Participants	788 Participants n=7 Participants	4478 Participants n=5 Participants
Race/Ethnicity, Customized Chinese	1242 Participants n=5 Participants	726 Participants n=7 Participants	1968 Participants n=5 Participants
Race/Ethnicity, Customized Indian	1591 Participants n=5 Participants	517 Participants n=7 Participants	2108 Participants n=5 Participants
Race/Ethnicity, Customized Malay	657 Participants n=5 Participants	95 Participants n=7 Participants	752 Participants n=5 Participants
Race/Ethnicity, Customized Others	1287 Participants n=5 Participants	209 Participants n=7 Participants	1496 Participants n=5 Participants
Race/Ethnicity, Customized NA	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
NYHA Class I/II	2752 Participants n=5 Participants	843 Participants n=7 Participants	3595 Participants n=5 Participants
NYHA Class III/IV	1576 Participants n=5 Participants	278 Participants n=7 Participants	1854 Participants n=5 Participants
NYHA Class Not assessed	451 Participants n=5 Participants	429 Participants n=7 Participants	880 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years follow up

Population: Patients with outcomes available at 1 year were examined for all-cause and cardiovascular (CV) death. Patients who were lost to follow-up were excluded from the analysis.

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

Outcome measures

Measure	HFrEF n=4737 Participants ejection fraction \<40%	HFpEF n=1114 Participants ejection fraction ≥50%
All Cause and Cause-specific Death All-cause mortality	500 Participants	60 Participants
All Cause and Cause-specific Death CV mortality	270 Participants	32 Participants

SECONDARY outcome

Timeframe: 2 years follow up

Population: ESC guidelines recommend an implantable cardioverter-defibrillator (ICD) device for primary prevention in symptomatic patients with heart failure with reduced ejection fraction (HFrEF), provided they are expected to survive substantially longer than one year with good functional status. For this outcome measure, only HFrEF patients who were eligible for ICD devices were included; HFpEF patients were excluded.

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

Outcome measures

Measure	HFrEF n=3240 Participants ejection fraction \<40%	HFpEF ejection fraction ≥50%
Sudden Cardiac Death	109 Participants	0 Participants

Adverse Events

HFrEF

Serious events: 500 serious events

Other events: 0 other events

Deaths: 500 deaths

HFpEF

Serious events: 60 serious events

Other events: 0 other events

Deaths: 60 deaths

Serious adverse events

Measure	HFrEF n=4737 participants at risk ejection fraction \<40%	HFpEF n=1114 participants at risk ejection fraction ≥50%
Cardiac disorders Death	10.6% 500/4737 • Number of events 500 • 2 years follow up Only all-cause mortality was reported. Other adverse event not applicable as this was an observational study with no Investigation product to be assessed.	5.4% 60/1114 • Number of events 60 • 2 years follow up Only all-cause mortality was reported. Other adverse event not applicable as this was an observational study with no Investigation product to be assessed.

Other adverse events

Adverse event data not reported

Additional Information

Carolyn Lam

National University Health System, Singapore

Phone: (65)67048965

Email: carolyn.lam@duke-nus.edu.sg

Results disclosure agreements

• Principal investigator is a sponsor employee Acknowledgement of funding: National Medical Research Council of Singapore (R-172-003-219-511), A\*STAR Biomedical Research Council Asian neTwork for Translational Research and Cardiovascular Trials (ATTRaCT) program (SPF2014/003, SPF2014/004, SPF2014/005), Boston Scientific Investigator Sponsored Research Program and Bayer.
• Publication restrictions are in place

Restriction type: OTHER