Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-29 @ 12:58 AM
Study NCT ID:
NCT01298232
Status:
UNKNOWN
Last Update Posted:
2011-02-17
First Post:
2011-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
One-year Outcomes of Electromechanical Activation Time (EMAT)-Guided vs. Symptom-guided Heart Failure Therapy in Acute Heart Failure Syndrome (AHFS) Patients
Sponsor:
Taipei Veterans General Hospital, Taiwan
Organization:
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2011-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: