Heart Failure, Wide QRS ComplexNCT00156390
Predictors of Response to Biventricular Pacing in Heart Failure
A study testing echo-guided left ventricular lead placement in people with Heart Failure, Wide QRS Complex, run by Samir Saba at 1 site in United States.
Trial summary
Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million individuals. It is estimated that in the next year nearly 400,000 new cases will be diagnosed, 1 million individuals will be hospitalized and 300,000 deaths will occur because of HF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Wide QRS Complex
- What is being tested?
- echo-guided left ventricular lead placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- age greater than 18 years Heart Failure Ejection fraction<35% QRS complex>120 ms
Who cannot join
- pregnant unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million individuals. It is estimated that in the next year nearly 400,000 new cases will be diagnosed, 1 million individuals will be hospitalized and 300,000 deaths will occur because of HF. Approximately half of the deaths will be attributed to worsening pump function while the remainder will be attributable to sudden cardiac death.
Biventricular (BIV) pacing has recently emerged as an exciting new treatment of advanced HF with dramatic benefits to some patients. Current candidates include those with ventricular conduction abnormalities and reduced ejection fraction who continue to suffer from severe HF symptoms despite optimal pharmacological therapy. Recent clinical trials have demonstrated that BIV pacing improves myocardial function, functional capacity, quality of life, as well as reduces the incidence of hospitalization and even prolongs life. Despite all this, about one third of patients with HF do not benefit from BIV pacing, the so-called 'non-responders'. Our group and others have shown that there are direct genetic effects of BiV pacing in an animal model, however, there are gaps in existing knowledge about the effects of left ventricular (LV) pacing site or genetic influences on the degree of response to this novel therapy.
This proposal aims at identifying predictors of benefit from Biventricular (BIV) pacing with the goal of optimizing the degree of benefit and increasing the proportion of patients who respond to this therapy. Patients who fulfill current indications for BIV pacing will undergo and echocardiography (echo) with regional tissue Doppler analysis and cardiac imaging consisting of a myocardial perfusion imaging(EGC rest gated Spect scan using Sestamibi) prior to implantation of a BIV pacing device. They will then be randomly assigned to empiric versus echo and Spect scan-guided LV lead positioning. In this latter group, optimal LV pacing site will be defined as the site of latest peak tissue velocity by tissue Doppler echo and Spect scan testing. In the empiric group, the LV lead position will be chosen by the masked operator based on the coronary sinus venous anatomy, on electrocardiographic (ECG) criteria, or other as per standard of care. Blood would be collected from all patients at the time of the procedure for analysis of genetic polymorphisms.
Read the detailed description
- To test the hypothesis that the number, size, location, and severity of myocardial perfusion defects and scar distribution dictate the pattern of LV dyssynchrony by tissue Doppler echocardiography and speckle tracking. An extensive body of literature exists describing the predictors of response to BIV pacing in HF patients. Our group and others have established a clear association between the presence of mechanical cardiac dyssynchrony and the response to BIV pacing. Also, our group and others have examined the effect defects on myocardial perfusion imaging (MIBI) scan on response to BIV pacing. What remains unclear is the relationship between the number, size, distribution, and severity of these perfusion defects and the pattern of dyssynchrony by echo. It seems plausible that the distribution of scar and/or perfusion abnormalities dictates the pattern of mechanical delay and the relative timing of contraction of the various parts of the LV. Approach: In this first phase of the proposal, we will utilize some of the techniques that are available to our group to correlate the patterns of perfusion defects with the patterns of mechanical dyssynchrony. For that purpose, patients with clinical indications for BIV pacing will undergo nuclear perfusion imaging at rest as well as echocardiographic (echo) imaging with tissue Doppler assessment and speckle tracking. The site of latest mechanical activation and pattern of mechanical contraction will then be compared to the sites of scar and/or perfusion defects on the resting MIBI scan. Anticipated Results: The purpose of this first phase of the proposal would be to identify if the dyssynchrony pattern is a downstream manifestation of the myocardial injury scheme and therefore, if it can be predicted based on the number, size, severity, and distribution of the perfusion abnormalities.
- To test the hypothesis that LV lead positioning away from dense scars as determined by resting nuclear perfusion imaging and close to the site of latest LV mechanical activation translates into improved response after BIV pacing. Our group and others have demonstrated improved acute hemodynamics and long term response to BIV pacing if the LV lead position was concordant with the site of latest mechanical activation of the LV. Also, our group and others have shown that an LV pacing lead positioned at the site of a scar or in the vicinity of a high scar density area is associated with little echocardiographic and clinical response after BIV pacing. To date, standard clinical practice continues to consist of placing the LV lead tip in the most lateral and posterior position. Maintaining this approach in all cardiomyopathy patients regardless of the nature of the myocardial insult or the sites of scaring may not be optimal and may account for the lack of response to BIV therapy in a significant number of patients. The primary objective of this specific aim is to demonstrate that MIBI/echo-guided LV lead placement is superior to standard lead placement and that patients who are randomized to the MIBI/echo-guided arm will exhibit greater improvement in the symptoms of HF and greater improvement of LV function at the 6-month interval compared to patients receiving standard LV lead placement. Approach: Heart failure patients (n=210) enrolled in this study will be randomly assigned in a 2:1 fashion to one of two study arms:
- Conditions
- Heart Failure, Wide QRS Complex
- Being tested
- echo-guided left ventricular lead placement, LV lead placement as per standard of care (without echo guidance)
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echo-guided left ventricular lead placementDevice
placement of the LV lead of the biventricular pacing device under echocardiographic guidance
LV lead placement as per standard of care (without echo guidance)Other
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | echo-guided LV lead placement Receives: Device: echo-guided left ventricular lead placement |
| 2 | Other | LV lead placement as per standard of care (without echo-guidance) Receives: Other: LV lead placement as per standard of care (without echo guidance) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota For Living With Heart Failure Questionnaire
Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = "no" heart failure did not prevent one from living as they want and 5= "yes"heart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life.
Measured: 1 year
Secondary outcomes (1)
Echocardiographic Changes
These parameters compared the echocardiographic measures at baseline prior to device implantations to those obtained 6 to 12 months after device implantation. Data for ESV and EF are presented as percent relative change (standard deviation)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure, Wide QRS ComplexStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samir Saba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samir Saba, University of Pittsburgh
- Investigators
- Samir Saba, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156390
- Sponsor's protocol ID
- 0504006
- Other IDs
- 0504006
- Status last verified
- Nov 2019
- First submitted
- 8 Sep 2005
- Last updated
- 6 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Saba S, Marek J, Schwartzman D, Jain S, Adelstein E, White P, Oyenuga OA, Onishi T, Soman P, Gorcsan J 3rd. Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy: results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial. Circ Heart Fail. 2013 May;6(3):427-34. doi: 10.1161/CIRCHEARTFAILURE.112.000078. Epub 2013 Mar 8.
PubMed 23476053
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Response to Biventricular Pacing in Heart Failure
- ClinicalTrials.gov ID
- NCT00156390
- Acronym / sponsor ID
- 0504006
- Conditions
- Heart Failure, Wide QRS Complex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Samir SabaUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 24 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heart Failure (HF) is a disease of epidemic proportion in the U.S. affecting over 5 million individuals. It is estimated that in the next year nearly 400,000 new cases will be diagnosed, 1 million individuals will be hospitalized and 300,000 deaths will occur because of HF. Approximately half of the deaths will be attributed to worsening pump function while the remainder will be attributable to sudden cardiac death.
Biventricular (BIV) pacing has recently emerged as an exciting new treatment of advanced HF with dramatic benefits to some patients. Current candidates include those with ventricular conduction abnormalities and reduced ejection fraction who continue to suffer from severe HF symptoms despite optimal pharmacological therapy. Recent clinical trials have demonstrated that BIV pacing improves myocardial function, functional capacity, quality of life, as well as reduces the incidence of hospitalization and even prolongs life. Despite all this, about one third of patients with HF do not benefit from BIV pacing, the so-called 'non-responders'. Our group and others have shown that there are direct genetic effects of BiV pacing in an animal model, however, there are gaps in existing knowledge about the effects of left ventricular (LV) pacing site or genetic influences on the degree of response to this novel therapy.
This proposal aims at identifying predictors of benefit from Biventricular (BIV) pacing with the goal of optimizing the degree of benefit and increasing the proportion of patients who respond to this therapy. Patients who fulfill current indications for BIV pacing will undergo and echocardiography (echo) with regional tissue Doppler analysis and cardiac imaging consisting of a myocardial perfusion imaging(EGC rest gated Spect scan using Sestamibi) prior to implantation of a BIV pacing device. They will then be randomly assigned to empiric versus echo and Spect scan-guided LV lead positioning. In this latter group, optimal LV pacing site will be defined as the site of latest peak tissue velocity by tissue Doppler echo and Spect scan testing. In the empiric group, the LV lead position will be chosen by the masked operator based on the coronary sinus venous anatomy, on electrocardiographic (ECG) criteria, or other as per standard of care. Blood would be collected from all patients at the time of the procedure for analysis of genetic polymorphisms.
Detailed description
- To test the hypothesis that the number, size, location, and severity of myocardial perfusion defects and scar distribution dictate the pattern of LV dyssynchrony by tissue Doppler echocardiography and speckle tracking. An extensive body of literature exists describing the predictors of response to BIV pacing in HF patients. Our group and others have established a clear association between the presence of mechanical cardiac dyssynchrony and the response to BIV pacing. Also, our group and others have examined the effect defects on myocardial perfusion imaging (MIBI) scan on response to BIV pacing. What remains unclear is the relationship between the number, size, distribution, and severity of these perfusion defects and the pattern of dyssynchrony by echo. It seems plausible that the distribution of scar and/or perfusion abnormalities dictates the pattern of mechanical delay and the relative timing of contraction of the various parts of the LV. Approach: In this first phase of the proposal, we will utilize some of the techniques that are available to our group to correlate the patterns of perfusion defects with the patterns of mechanical dyssynchrony. For that purpose, patients with clinical indications for BIV pacing will undergo nuclear perfusion imaging at rest as well as echocardiographic (echo) imaging with tissue Doppler assessment and speckle tracking. The site of latest mechanical activation and pattern of mechanical contraction will then be compared to the sites of scar and/or perfusion defects on the resting MIBI scan. Anticipated Results: The purpose of this first phase of the proposal would be to identify if the dyssynchrony pattern is a downstream manifestation of the myocardial injury scheme and therefore, if it can be predicted based on the number, size, severity, and distribution of the perfusion abnormalities.
- To test the hypothesis that LV lead positioning away from dense scars as determined by resting nuclear perfusion imaging and close to the site of latest LV mechanical activation translates into improved response after BIV pacing. Our group and others have demonstrated improved acute hemodynamics and long term response to BIV pacing if the LV lead position was concordant with the site of latest mechanical activation of the LV. Also, our group and others have shown that an LV pacing lead positioned at the site of a scar or in the vicinity of a high scar density area is associated with little echocardiographic and clinical response after BIV pacing. To date, standard clinical practice continues to consist of placing the LV lead tip in the most lateral and posterior position. Maintaining this approach in all cardiomyopathy patients regardless of the nature of the myocardial insult or the sites of scaring may not be optimal and may account for the lack of response to BIV therapy in a significant number of patients. The primary objective of this specific aim is to demonstrate that MIBI/echo-guided LV lead placement is superior to standard lead placement and that patients who are randomized to the MIBI/echo-guided arm will exhibit greater improvement in the symptoms of HF and greater improvement of LV function at the 6-month interval compared to patients receiving standard LV lead placement. Approach: Heart failure patients (n=210) enrolled in this study will be randomly assigned in a 2:1 fashion to one of two study arms:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: echo-guided left ventricular lead placementecho-guided LV lead placement |
| 2 | Other | Other: LV lead placement as per standard of care (without echo guidance)LV lead placement as per standard of care (without echo-guidance) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age greater than 18 years Heart Failure Ejection fraction<35% QRS complex>120 ms
Key exclusion criteria (1 listed)
- pregnant unable to consent
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 |
|---|---|---|
| echo-guided left ventricular lead placementplacement of the LV lead of the biventricular pacing device under echocardiographic guidance | Device | 1 |
| LV lead placement as per standard of care (without echo guidance) | Other | 2 |
Primary outcome
Minnesota For Living With Heart Failure Questionnaire
Time frame: 1 year
Quality of Life Questionnaire List of 21 Questions; each question has a Scale 0-5 with 0 = "no" heart failure did not prevent one from living as they want and 5= "yes"heart failure prevented one very much from living as they want. Overall scores between 0-105, with 105 being the worse quality of life.
1 secondary outcome
Echocardiographic Changes
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23476053Saba S, Marek J, Schwartzman D, Jain S, Adelstein E, White P, Oyenuga OA, Onishi T, Soman P, Gorcsan J 3rd. Echocardiography-guided left ventricular lead placement for cardiac resynchronization therapy: results of the Speckle Tracking Assisted Resynchronization Therapy for Electrode Region trial. Circ Heart Fail. 2013 May;6(3):427-34. doi: 10.1161/CIRCHEARTFAILURE.112.000078. Epub 2013 Mar 8.
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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.
Samir Saba, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing echo-guided left ventricular lead placement in people with Heart Failure, Wide QRS Complex, run by Samir Saba 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 1 inclusion and 1 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 6 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 24 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Minnesota For Living With Heart Failure Questionnaire (time frame: 1 year). 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 NCT00156390, 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 6 Nov 2019.