Dilated CardiomyopathyPhase 1/2BiBETNCT01290822
Optimized Biventricular Pacing Allograft Recipients
A Phase 1/2 study testing BiVP and AAI Pacing in people with Dilated Cardiomyopathy and Ischemic Cardiomyopathy, run by Henry M. Spotnitz at 1 site in United States.
Trial summary
This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dilated Cardiomyopathy, Ischemic Cardiomyopathy
- What is being tested?
- BiVP and AAI Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Mar 2011
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New York Heart Association (NYHA) heart failure class III/IV
- Left Ventricular Ejection Fraction (LVEF) <36%
- QRS >120 msec
Who cannot join
- Intracardiac shunts
- Sinus tachycardia >120 bpm
- Second or third degree heart block
- Previous cardiac surgery
- Mechanical circulatory assistance
- Atrial fibrillation
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medial Center
New York, New York, 10032
About this study
Official title: Optimized Biventricular Pacing in Allograft Recipients
This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure. It examines the effects of atrioventricular delay (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an identical heart rate.
Read the detailed description
This study is designed to increase the benefit of biventricular pacing (BiVP), which is an established therapy for advanced heart failure. The investigators will test 6 left ventricular (LV) pacing sites and 16 timing sequences in the operating room just before cardiac transplant. Pacing will be implemented after patients have been anticoagulated and connected to the heart-lung machine. Pacing by previously implanted pacemakers will be suppressed. The investigators will measure cardiac output (CO) by aortic flow probe (AFP), left ventricular (LV) contractility by a combination of trans-septal pressure gradients, and simultaneous left ventricular pressure (LVP)and transesophageal echocardiography (TEE) during transient reduction of inflow of blood to the heart by vena caval occlusion. The goal is to prove that this optimization will increase the amount of blood pumped by the failing heart by 15% as compared with standard atrial (AAI) pacing. The testing protocol is 12.5 minutes in duration, and the entire protocol should be executable in 20 minutes. Care will not be altered otherwise. Results will improve management of the general population of patients with advanced heart failure while minimally increasing the risk to patients undergoing cardiac transplantation. Benefits of this study should include: improved patient selection for BiVP and a decrease in the presently recognized 30-40% incidence of BiVP nonresponders.
- Conditions
- Dilated Cardiomyopathy, Ischemic Cardiomyopathy
- Being tested
- BiVP, AAI Pacing
- Keywords
- Biventricular pacing, Dilated Cardiomyopathy, Ischemic Cardiomyopathy, Congestive heart failure, Cardiac allograft, Cardiac surgery, AVD, VVD, LV pacing site, pacing optimization
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiVPDevice
Also called Biventricular Pacing
Biventricular pacing
AAI PacingDevice
Also called Atrial Pacing
Atrial pacing
| Study group | Role | What they receive |
|---|---|---|
| BiVP Pacing | Experimental | BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output. Receives: Device: BiVP |
| AAI Pacing | Active comparator | Traditional atrial (AAI) pacing Receives: Device: AAI Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.
Measured: 13 minutes of testing; performed before CPB for allograft receipt
Secondary outcomes (5)
Atrial Latency
Measured: 13 minutes of testing; performed before CPB for allograft receipt
Interatrial Delay (Between Right Atrium and Left Atrium)
Results could not be analyzed due to poor enrollment and lack of data.
Measured: 13 minutes of testing; performed before CPB for allograft receipt
Peak LV dP/dt
Measured: 13 minutes of testing; performed before CPB for allograft receipt
Peak RV dP/dt
Measured: 13 minutes of testing; performed before CPB for allograft receipt
Interventricular Synchrony
Measured: 13 minutes of testing; performed before CPB for allograft receipt
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startJan 2007
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Slow accrual and anticipated loss of funding
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.
- Other trials for Dilated CardiomyopathyStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Spotnitz
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Henry M. Spotnitz, Columbia University
- Investigators
- Henry M Spotnitz, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290822
- Sponsor's protocol ID
- AAAC1492
- Other IDs
- 1R01HL080152-01A2
- Acronym
- BiBET
- Status last verified
- Aug 2016
- First submitted
- 2 Feb 2011
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Biventricular Pacing in Allograft Recipients
- ClinicalTrials.gov ID
- NCT01290822
- Acronym / sponsor ID
- BiBET / AAAC1492
- Conditions
- Dilated Cardiomyopathy, Ischemic Cardiomyopathy
- Keywords
- Biventricular pacing, Dilated Cardiomyopathy, Ischemic Cardiomyopathy, Congestive heart failure, Cardiac allograft, Cardiac surgery, AVD, VVD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual and anticipated loss of funding
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Henry M. SpotnitzUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 15 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure. It examines the effects of atrioventricular delay (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an identical heart rate.
Detailed description
This study is designed to increase the benefit of biventricular pacing (BiVP), which is an established therapy for advanced heart failure. The investigators will test 6 left ventricular (LV) pacing sites and 16 timing sequences in the operating room just before cardiac transplant. Pacing will be implemented after patients have been anticoagulated and connected to the heart-lung machine. Pacing by previously implanted pacemakers will be suppressed. The investigators will measure cardiac output (CO) by aortic flow probe (AFP), left ventricular (LV) contractility by a combination of trans-septal pressure gradients, and simultaneous left ventricular pressure (LVP)and transesophageal echocardiography (TEE) during transient reduction of inflow of blood to the heart by vena caval occlusion. The goal is to prove that this optimization will increase the amount of blood pumped by the failing heart by 15% as compared with standard atrial (AAI) pacing. The testing protocol is 12.5 minutes in duration, and the entire protocol should be executable in 20 minutes. Care will not be altered otherwise. Results will improve management of the general population of patients with advanced heart failure while minimally increasing the risk to patients undergoing cardiac transplantation. Benefits of this study should include: improved patient selection for BiVP and a decrease in the presently recognized 30-40% incidence of BiVP nonresponders.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BiVP Pacing | Experimental | Device: BiVPBIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output. |
| AAI Pacing | Active comparator | Device: AAI PacingTraditional atrial (AAI) pacing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- New York Heart Association (NYHA) heart failure class III/IV
- Left Ventricular Ejection Fraction (LVEF) <36%
- QRS >120 msec
Key exclusion criteria (6 listed)
- Intracardiac shunts
- Sinus tachycardia >120 bpm
- Second or third degree heart block
- Previous cardiac surgery
- Mechanical circulatory assistance
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 |
|---|---|---|
| BiVPAlso: Biventricular PacingBiventricular pacing | Device | BiVP Pacing |
| AAI PacingAlso: Atrial PacingAtrial pacing | Device | AAI Pacing |
Primary outcome
Cardiac Output
Time frame: 13 minutes of testing; performed before CPB for allograft receipt
The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.
5 secondary outcomes
Atrial Latency
Time frame: 13 minutes of testing; performed before CPB for allograft receipt
Interatrial Delay (Between Right Atrium and Left Atrium)
Time frame: 13 minutes of testing; performed before CPB for allograft receipt
Peak LV dP/dt
Time frame: 13 minutes of testing; performed before CPB for allograft receipt
Peak RV dP/dt
Time frame: 13 minutes of testing; performed before CPB for allograft receipt
Interventricular Synchrony
Time frame: 13 minutes of testing; performed before CPB for allograft receipt
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Henry M Spotnitz, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BiVP and AAI Pacing in people with Dilated Cardiomyopathy and Ischemic Cardiomyopathy, run by Henry M. Spotnitz 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 6 Oct 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2016). 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?
Cardiac Output (time frame: 13 minutes of testing; performed before CPB for allograft receipt). 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 6 Oct 2016.