NCT01298232

Brief Summary

Left ventricular systolic time intervals, including pre-ejection period (PEP), ejection time (ET), and their ratio (PEP/ET), is determined by the systolic and diastolic function and ventriculo-arterial coupling. The investigators have shown the usefulness of the electromechanical activation time (EMAT, equals PEP minus isovolumic contraction time) in the prediction of cardiac mortality or re-hospitalization for heart failure in patients with the acute heart failure syndrome (AHFS). Therefore, the objective of the present proposal is to compare 12-month outcomes of EMAT-guided vs symptom-guided heart failure therapy in patients with AHFS.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 17, 2011

Status Verified

January 1, 2011

Enrollment Period

2.9 years

First QC Date

February 15, 2011

Last Update Submit

February 16, 2011

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular mortality and heart failure rehospitalization

    within 1 year after discharge

Secondary Outcomes (1)

  • All-cause mortality

    within 1 year after discharge

Study Arms (2)

EMAT-guided therapy

NO INTERVENTION

electromechanical activation time (EMAT, obtain by phonocardiogram, Audicor, USA)

Other: Cardiophonogram

Symptomatic-guided therapy

NO INTERVENTION

HF therapy guided by clinical symptoms

Other: Cardiophonogram

Interventions

CardiophonogramOTHER

Using data from cardiophonogram, the EMAT and S3 intensity, to guided clinical therapy for acute heart failure

EMAT-guided therapySymptomatic-guided therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are hospitalized due to AHFS and have a plasma NT-proBNP ≥ 1600 pg/ml at admission.
  • Patients give written consents to participate in the study.

You may not qualify if:

  • Patients with an implanted pacemaker.
  • Patients with chronic kidney disease, stage 5 and warranted dialysis.
  • Patients with hypertrophic obstructive cardiomyopathy.
  • Patients with cardiac temponade or constrictive pericarditis.
  • Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 1 months prior to index hospitalization.
  • Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after discharge at index hospitalization.
  • Patients with left ventricular assistance device (LVAD device).
  • Documented ventricular arrhythmia with syncope episodes within past 3 months, prior to index hospitalization that is untreated.
  • Symptomatic bradycardia or second or third degree heart block without a pacemaker.
  • Implantation of a CRT (cardiac resynchronization therapy) device within the prior 1 month before index hospitalization or intent to implant a CRT device.
  • Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.
  • Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.
  • Severe primary pulmonary, renal or hepatic disease.
  • Presence of any other disease with a life expectancy of \< 1 year.
  • Subjects get pregnant or will be pregnant within 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hsopital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Related Publications (1)

  • Sung SH, Huang CJ, Cheng HM, Huang WM, Yu WC, Chen CH. Effect of Acoustic Cardiography-guided Management on 1-year Outcomes in Patients With Acute Heart Failure. J Card Fail. 2020 Feb;26(2):142-150. doi: 10.1016/j.cardfail.2019.09.012. Epub 2019 Sep 27.

    PMID: 31568829DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 17, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 17, 2011

Record last verified: 2011-01

Locations

TW(2)