Heart FailureNCT00205192
Optimizing Cardiac Resynchronization
An observational study of Heart Failure, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Cardiac resynchronization therapy shows great promise as a method to improve ventricular function in heart failure due to dilated cardiomyopathy. It is applied to patients with class III and IV symptomatic heart failure on optimal therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac resynchronization pacing
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study.
Who may be able to join
- All patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study.
- The study is only open to patients as enumerated above, and also patients who have good imaging windows.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac resynchronization therapy shows great promise as a method to improve ventricular function in heart failure due to dilated cardiomyopathy. It is applied to patients with class III and IV symptomatic heart failure on optimal therapy. Typical entry criteria in the trials testing resynchronization have used the electrocardiogram and a prolonged electrocardiogram (ECG) QRS interval as criteria for dyssynchrony. This is recognized to be quite limited as a tool for identifying patients. Several new echocardiographic methods for identifying dyssynchrony have been proposed. The purpose of this study is to systematically examine these multiple echocardiographic measurement techniques in three conditions:
- in the patient's native rhythm simulated by changing the pacing system to atrial pacing only;
- in conventional dual chamber pacing (DDD mode); and
- during biventricular pacing. All patients entered into this study will already have had a biventricular pacemaker placed.
- Conditions
- Heart Failure
- Being tested
- Cardiac resynchronization pacing
- Keywords
- Heart Failure, Cardiac resynchronization, echocardiography
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization pacingProcedure or surgery
various pacemaker modes used over 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionDec 2011
- Study completionDec 2011
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter S Rahko, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205192
- Sponsor's protocol ID
- H-2004-0335
- Status last verified
- Aug 2012
- First submitted
- 12 Sep 2005
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cardiac Resynchronization
- ClinicalTrials.gov ID
- NCT00205192
- Acronym / sponsor ID
- H-2004-0335
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Cardiac resynchronization, echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Sep 2005 (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.
Cardiac resynchronization therapy shows great promise as a method to improve ventricular function in heart failure due to dilated cardiomyopathy. It is applied to patients with class III and IV symptomatic heart failure on optimal therapy. Typical entry criteria in the trials testing resynchronization have used the electrocardiogram and a prolonged electrocardiogram (ECG) QRS interval as criteria for dyssynchrony. This is recognized to be quite limited as a tool for identifying patients. Several new echocardiographic methods for identifying dyssynchrony have been proposed. The purpose of this study is to systematically examine these multiple echocardiographic measurement techniques in three conditions:
- in the patient's native rhythm simulated by changing the pacing system to atrial pacing only;
- in conventional dual chamber pacing (DDD mode); and
- during biventricular pacing. All patients entered into this study will already have had a biventricular pacemaker placed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study.
Key inclusion criteria (2 listed)
- All patients who have previously had a resynchronization pacemaker system placed at the University of Wisconsin Hospital or at the Middleton Veterans Hospital are potentially eligible for this study.
- The study is only open to patients as enumerated above, and also patients who have good imaging windows.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cardiac resynchronization pacingvarious pacemaker modes used over 1 hour | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 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.
Peter S Rahko, MD principal investigator
University of Wisconsin, Madison
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 Heart Failure, run by University of Wisconsin, Madison 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 2 inclusion and 0 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: finished, as of the sponsor's last update on 29 Aug 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 29 Aug 2012; AzTrials last refreshed its copy on 28 Oct 2026.