One-year Outcomes of Electromechanical Activation Time (EMAT)-Guided vs. Symptom-guided Heart Failure Therapy in Acute Heart Failure Syndrome (AHFS) Patients
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cardiophonogram
Sponsored by

About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- National Taiwan University HsopitalRecruiting
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
No Intervention
Arm Label
EMAT-guided therapy
Symptomatic-guided therapy
Arm Description
electromechanical activation time (EMAT, obtain by phonocardiogram, Audicor, USA)
HF therapy guided by clinical symptoms
Outcomes
Primary Outcome Measures
Cardiovascular mortality and heart failure rehospitalization
Secondary Outcome Measures
All-cause mortality
Full Information
NCT ID
NCT01298232
First Posted
February 15, 2011
Last Updated
February 16, 2011
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT01298232
Brief Title
One-year Outcomes of Electromechanical Activation Time (EMAT)-Guided vs. Symptom-guided Heart Failure Therapy in Acute Heart Failure Syndrome (AHFS) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
A total of 120 patients aged 18 years or older and hospitalized at Taipei Veterans General Hospital or National Taiwan University Hospital due to AHFS will be enrolled in three years, and randomized into 2 treatment strategies, that is, intensified (EMAT-guided) therapy or standard (symptom-guided) therapy. Systolic time intervals and EMAT normalized by cardiac cycle length (%) are measured separately by separate automated acoustic devices. All parameters will be assessed within 24 hours before discharge, and at 2 weeks, and 3, 6, and 12 months after discharge. Patients randomized to the EMAT-guided group will undergo intensified therapy of heart failure with the goal to reduce both %EMAT<15 and symptoms to NYHA ≤II. Patients randomized to the symptom-guided group will have standard medical care, with the goal to reduce symptoms to NYHA ≤II. The primary efficacy variable is defined as the time to cardiovascular death or heart failure hospitalization within 1 year after randomization. This study will be the first prospective randomized controlled trial to study the management of patients with AHFS using EMAT and will provide unique information comparing two treatment strategies irrespective of natriuretic peptides regarding prognosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EMAT-guided therapy
Arm Type
No Intervention
Arm Description
electromechanical activation time (EMAT, obtain by phonocardiogram, Audicor, USA)
Arm Title
Symptomatic-guided therapy
Arm Type
No Intervention
Arm Description
HF therapy guided by clinical symptoms
Intervention Type
Other
Intervention Name(s)
Cardiophonogram
Intervention Description
Using data from cardiophonogram, the EMAT and S3 intensity, to guided clinical therapy for acute heart failure
Primary Outcome Measure Information:
Title
Cardiovascular mortality and heart failure rehospitalization
Time Frame
within 1 year after discharge
Secondary Outcome Measure Information:
Title
All-cause mortality
Time Frame
within 1 year after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Facility Information:
Facility Name
National Taiwan University Hsopital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang-Yu Lin
Email
lin7010@ms1.hinet.net
First Name & Middle Initial & Last Name & Degree
Liang-Yu Lin
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen-Huan Chen, M.D.
Phone
886228752073
First Name & Middle Initial & Last Name & Degree
Chen-Huan Chen, M.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
31568829
Citation
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.
Results Reference
derived
Learn more about this trial
One-year Outcomes of Electromechanical Activation Time (EMAT)-Guided vs. Symptom-guided Heart Failure Therapy in Acute Heart Failure Syndrome (AHFS) Patients
We'll reach out to this number within 24 hrs