Systolic Heart FailureNCT01127334
Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device
An observational study of Systolic Heart Failure, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Heart Failure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to May 2011
- 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: Cardiology and electrophysiology clinics
Who may be able to join
- Adults age 18-110 years
- Must have a CRT-D (A biventricular pacemaker with defibrillator)
- Last optimization of their device (CRT-D) must not have been done in the past 3 months
- Must be optimal heart failure medical regimen. This includes target dose of beta-blocker and angiotensin converting enzyme inhibitor (ACE-I) (or equivalent; i.e angiotensin receptor blocker (ARB); or balanced preload and afterload reducers with hydralazine and nitrates.)
Who cannot join
- Less than 18 years of age or greater than 110 years old.
- Does not have a CRT-D
- Optimization of their device has occurred in the past 3 months
- Not on optimal medical therapy for heart failure as listed in the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Validation of a Robust Method for Kinematic Analysis of Ventricular Mechanical Dyssynchrony by Two Dimensional Echocardiography in Patients With Cardiac Resynchronization Devices for Chronic Systolic Heart Failure and Conduction System Disease
Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.
- Conditions
- Systolic Heart Failure
- Keywords
- Dyssynchrony, Cardiac resynchronization therapy
- Medical subject headings
- Heart Failure, Systolic
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 |
|---|---|---|
| Systolic Heart Failure, Dyssynchrony, CRT-D | Patients with systolic heart failure and dyssynchrony that have a CRT-D that have not been optimized in the past 3 months. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Principal Investigator terminated study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Donny R. Stokes, M.D., Principal investigator, University of Mississippi Medical CenterJohn P. Payne, M.D., Study director, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127334
- Sponsor's protocol ID
- 2010-0069
- Status last verified
- May 2010
- First submitted
- 19 May 2010
- Last updated
- 4 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Robust Method for Kinematic Analysis of Ventricular Mechanical Dyssynchrony by Two Dimensional Echocardiography in Patients With Cardiac Resynchronization Devices for Chronic Systolic Heart Failure and Conduction System Disease
- ClinicalTrials.gov ID
- NCT01127334
- Acronym / sponsor ID
- 2010-0069
- Conditions
- Systolic Heart Failure
- Keywords
- Dyssynchrony, Cardiac resynchronization therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator terminated study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 20 May 2010 (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.
Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systolic Heart Failure, Dyssynchrony, CRT-D | – | –Patients with systolic heart failure and dyssynchrony that have a CRT-D that have not been optimized in the past 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiology and electrophysiology clinics
Key inclusion criteria (4 listed)
- Adults age 18-110 years
- Must have a CRT-D (A biventricular pacemaker with defibrillator)
- Last optimization of their device (CRT-D) must not have been done in the past 3 months
- Must be optimal heart failure medical regimen. This includes target dose of beta-blocker and angiotensin converting enzyme inhibitor (ACE-I) (or equivalent; i.e angiotensin receptor blocker (ARB); or balanced preload and afterload reducers with hydralazine and nitrates.)
Key exclusion criteria (4 listed)
- Less than 18 years of age or greater than 110 years old.
- Does not have a CRT-D
- Optimization of their device has occurred in the past 3 months
- Not on optimal medical therapy for heart failure as listed in the inclusion criteria.
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
Not reported in the source record.
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 Apr 2012.
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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.
Donny R. Stokes, M.D. principal investigator
University of Mississippi Medical Center
John P. Payne, M.D. study director
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systolic Heart Failure, run by University of Mississippi Medical Center at 1 site in United States.
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 4 inclusion and 4 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 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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.
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 Apr 2012; AzTrials last refreshed its copy on 27 Oct 2026.