Heart FailureNCT01007981
A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony
An observational study of Heart Failure, run by University of Missouri-Columbia.
Trial summary
The investigators hypothesize that the relation between mechanical and hemodynamic left ventricular dyssynchrony might better predict response to Cardiac Resynchronization Device(CRT) than currently existing echo indices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to May 2010
- Phase
- Observational
- 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
Study population: Patients followed in cardiology clinic will be included.
Who may be able to join
- Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years.
Who cannot join
- Acute decompensated congestive heart failure.
- chronic permanent atrial fibrillation
About this study
Official title: A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony: Hemodynamic Assessment by 4D Segmental Ejection Fraction
The investigators hypothesize that the relation between mechanical and hemodynamic left ventricular dyssynchrony might better predict response to Cardiac Resynchronization Device(CRT) than currently existing echo indices.
Read the detailed description
Cardiac resynchronization therapy is emerging to be a highly effective treatment option for selected patients with symptomatic congestive heart failure on optimal medical therapy and evidence of left ventricular (LV) conduction delay and contraction dyssynchrony. It can improve quality of life and results in better survival in this selected group of patients. However, patients have different responses to CRT, and up to 30% of those implanted show no response at all. Ongoing trials, whether prospective or retrospective, have been trying to define best predictors of response to CRT and to measure ventricular dyssynchrony. Despite this, no single echo criterion to date can predict successful CRT over current guidelines.
In this study, we propose to compare LV muscle mechanical dyssynchrony assessment by speckle tracking to hemodynamic dyssynchrony assessment by 4D segmental ejection fraction (EF), a novel modality brought recently by University of Missouri Echocardiography laboratory.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CRT device | Patients with Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years will be studied by the new echo modality.Study doesn't involve acute device implantation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
4D echo is the best modality to measure systolic dyssynchrony index
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startNov 2008
- Primary completionMay 2010 (estimated)
- Study completionMay 2010 (estimated)
Why it stopped: investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Firas H El Sabbagh, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007981
- Sponsor's protocol ID
- 1124400
- Status last verified
- Oct 2016
- First submitted
- 4 Nov 2009
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Echocardiography Modality to Assess Left Ventricular Dyssynchrony: Hemodynamic Assessment by 4D Segmental Ejection Fraction
- ClinicalTrials.gov ID
- NCT01007981
- Acronym / sponsor ID
- 1124400
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- May 2010 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 5 Nov 2009 (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.
The investigators hypothesize that the relation between mechanical and hemodynamic left ventricular dyssynchrony might better predict response to Cardiac Resynchronization Device(CRT) than currently existing echo indices.
Detailed description
Cardiac resynchronization therapy is emerging to be a highly effective treatment option for selected patients with symptomatic congestive heart failure on optimal medical therapy and evidence of left ventricular (LV) conduction delay and contraction dyssynchrony. It can improve quality of life and results in better survival in this selected group of patients. However, patients have different responses to CRT, and up to 30% of those implanted show no response at all. Ongoing trials, whether prospective or retrospective, have been trying to define best predictors of response to CRT and to measure ventricular dyssynchrony. Despite this, no single echo criterion to date can predict successful CRT over current guidelines.
In this study, we propose to compare LV muscle mechanical dyssynchrony assessment by speckle tracking to hemodynamic dyssynchrony assessment by 4D segmental ejection fraction (EF), a novel modality brought recently by University of Missouri Echocardiography laboratory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRT device | – | –Patients with Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years will be studied by the new echo modality.Study doesn't involve acute device implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed in cardiology clinic will be included.
Key inclusion criteria (1 listed)
- Cardiac Resynchronization Therapy(CRT) device implanted in the last 5 years.
Key exclusion criteria (2 listed)
- Acute decompensated congestive heart failure.
- chronic permanent atrial fibrillation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
4D echo is the best modality to measure systolic dyssynchrony index
Time frame: Two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Firas H El Sabbagh, MD principal investigator
University of Missouri-Columbia
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University of Missouri-Columbia.
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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4D echo is the best modality to measure systolic dyssynchrony index (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2016.