One-year Outcomes of Electromechanical Activation Time (EMAT)-Guided vs. Symptom-guided Heart Failure Therapy in Acute Heart Failure Syndrome (AHFS) Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01298232
First received: February 15, 2011
Last updated: February 16, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Heart Failure
Other: Cardiophonogram

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Cardiovascular mortality and heart failure rehospitalization [ Time Frame: within 1 year after discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: within 1 year after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: EMAT-guided therapy
electromechanical activation time (EMAT, obtain by phonocardiogram, Audicor, USA)
Other: Cardiophonogram
Using data from cardiophonogram, the EMAT and S3 intensity, to guided clinical therapy for acute heart failure
No Intervention: Symptomatic-guided therapy
HF therapy guided by clinical symptoms
Other: Cardiophonogram
Using data from cardiophonogram, the EMAT and S3 intensity, to guided clinical therapy for acute heart failure

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients with an implanted pacemaker.
  2. Patients with chronic kidney disease, stage 5 and warranted dialysis.
  3. Patients with hypertrophic obstructive cardiomyopathy.
  4. Patients with cardiac temponade or constrictive pericarditis.
  5. 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.
  6. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after discharge at index hospitalization.
  7. Patients with left ventricular assistance device (LVAD device).
  8. Documented ventricular arrhythmia with syncope episodes within past 3 months, prior to index hospitalization that is untreated.
  9. Symptomatic bradycardia or second or third degree heart block without a pacemaker.
  10. Implantation of a CRT (cardiac resynchronization therapy) device within the prior 1 month before index hospitalization or intent to implant a CRT device.
  11. Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.
  12. Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.
  13. Severe primary pulmonary, renal or hepatic disease.
  14. Presence of any other disease with a life expectancy of < 1 year.
  15. Subjects get pregnant or will be pregnant within 1 month.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298232

Locations
Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Chen-Huan Chen, M.D.    886228752073      
Principal Investigator: Chen-Huan Chen, M.D.         
National Taiwan University Hsopital Recruiting
Taipei, Taiwan
Contact: Liang-Yu Lin       lin7010@ms1.hinet.net   
Principal Investigator: Liang-Yu Lin         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
  More Information

No publications provided

Responsible Party: Taipei Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01298232     History of Changes
Other Study ID Numbers: 100-01-001C
Study First Received: February 15, 2011
Last Updated: February 16, 2011
Health Authority: Taiwan: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 20, 2014