Heart FailureNCT01298232
One-year Outcomes of Electromechanical Activation Time (EMAT)-Guided vs. Symptom-guided Heart Failure Therapy in Acute Heart Failure Syndrome (AHFS) Patients
A study testing Cardiophonogram in people with Heart Failure, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiophonogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesTaiwan
- Study dates
- Jan 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hsopital
Taipei
Liang-Yu Lin, lin7010@ms1.hinet.net
Liang-Yu Lin
- Recruiting
Taipei Veterans General Hospital
Taipei
Chen-Huan Chen, M.D., 886228752073
Chen-Huan Chen, M.D.
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Cardiophonogram
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiophonogramOther
Using data from cardiophonogram, the EMAT and S3 intensity, to guided clinical therapy for acute heart failure
| Study group | Role | What they receive |
|---|---|---|
| EMAT-guided therapy | No intervention | electromechanical activation time (EMAT, obtain by phonocardiogram, Audicor, USA) Receives: Other: Cardiophonogram |
| Symptomatic-guided therapy | No intervention | HF therapy guided by clinical symptoms Receives: Other: Cardiophonogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular mortality and heart failure rehospitalization
Measured: within 1 year after discharge
Secondary outcomes (1)
All-cause mortality
Measured: within 1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298232
- Sponsor's protocol ID
- 100-01-001C
- Status last verified
- Jan 2011
- First submitted
- 15 Feb 2011
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31568829
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-year Outcomes of Electromechanical Activation Time (EMAT)-Guided vs. Symptom-guided Heart Failure Therapy in Acute Heart Failure Syndrome (AHFS) Patients
- ClinicalTrials.gov ID
- NCT01298232
- Acronym / sponsor ID
- 100-01-001C
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMAT-guided therapy | No intervention | Other: Cardiophonogramelectromechanical activation time (EMAT, obtain by phonocardiogram, Audicor, USA) |
| Symptomatic-guided therapy | No intervention | Other: CardiophonogramHF therapy guided by clinical symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardiophonogramUsing data from cardiophonogram, the EMAT and S3 intensity, to guided clinical therapy for acute heart failure | Other | EMAT-guided therapy, Symptomatic-guided therapy |
Primary outcome
Cardiovascular mortality and heart failure rehospitalization
Time frame: within 1 year after discharge
1 secondary outcome
All-cause mortality
Time frame: within 1 year after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
- Derived from this study: PubMed 31568829Sung 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiophonogram in people with Heart Failure, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular mortality and heart failure rehospitalization (time frame: within 1 year after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01298232, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011.