Heart FailureEarly Phase 1BRAVO-CRTNCT00794183
A Pilot Study Comparing the Programmed Delay Between the Atrial and Ventricle Interval
A Early Phase 1 study testing CRT device settings in people with Heart Failure, run by University of Minnesota at 1 site in United States.
Trial summary
The idea of this study is to compare different ways of setting up a pacemaker, using blood tests to give us information about how well it's working. We hope to learn if we can use this approach to figure out the best pacemaker setup ("programming") for each individual patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT device settings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Nov 2010
- Phase
- Early Phase 1
- 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
Who may be able to join
- Diagnosis of chronic heart failure
- patients on stable pharmacologic therapy for at least 3 months
- EF< 35%
- age >18 years
- NYHA functional class III or IV
- eligible for either CRT pacer or CRT defibrillator for heart failure
- Ischemic or non-ischemic cardiomyopathy
- patients that are able to tolerate VDD mode with a lower rate of 40bpm programming
Who cannot join
- systolic blood pressure <70mmHg
- Likely to receive a left ventricular assist device or cardiac transplant within 6 months of implant procedure
- patients who have previously received a CRT device
- documented atrial fibrillation
- complete heart block
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Pilot Study of theRelationship Between Atrio-Ventricular Delay and Changes in Biochemical Markers of Chronic Heart Failure During Cardiac Resynchronization Therapy (BRAVO-CRT)
The idea of this study is to compare different ways of setting up a pacemaker, using blood tests to give us information about how well it's working. We hope to learn if we can use this approach to figure out the best pacemaker setup ("programming") for each individual patient.
The setting we propose to adjust is the timing between the impulse sent between top and bottom chambers.
Read the detailed description
There are different kinds of pacemakers and different ways they can be set up to try to make the heart beat regularly. A normal heart has four chambers; these four chambers pump in a co-ordinated way to move blood effectively. When pacemakers were first invented, they told the heart when to pump, but didn't make the four chambers work well together. Newer pacemakers can give more detailed instructions, so the chambers work together more effectively. We already know that the newer (bi-ventricular) pacemakers work better for some patients with heart failure.
There are blood tests (often referred to as "markers") that give us information about how well your heart is working and about how your body is responding to heart failure. The idea of this study is to compare different ways of setting up a pacemaker, using these blood tests to give us information about how well it's working. We hope to learn if we can use this approach to figure out the best pacemaker setup ("programming") for each individual patient.
Usually pacemakers have two wires or leads, one is in the top right chamber and the other in the bottom right chamber of the heart. The newer pacemakers, which are given to patients with heart failure, have an additional lead or wire, which goes to the left side of the heart. So when heart contracts the lead from top chamber sends impulses to bottom chambers and the leads in right and left sides of bottom chamber responds by sending impulses in a co-ordinated way enabling heart to contract efficiently.
Currently, the standard way of treating patients with heart failure is by pacing the top and then bottom chambers, based on a timing interval determined by ultrasound, while also pacing the two bottom chambers in a coordinated manner. There are differences of opinion among experts and by previous studies regarding this method. Pacing is accomplished through pacemaker wires, which are placed in the right top chamber, the right bottom chamber and the left bottom chamber of the heart.
The setting we propose to adjust is the timing between the impulse sent between top and bottom chambers.
- Conditions
- Heart Failure
- Being tested
- CRT device settings
- Keywords
- heart failure, CRT, CHF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT device settingsDevice
Comparision of A-V delay settings
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AVD set by taking the larger of 0.50ms or A-V interval 0.30 Receives: Device: CRT device settings |
| 2 | Active comparator | AVD set by taking the larger of 0.50ms or A-V interval 0.50 Receives: Device: CRT device settings |
| 3 | Active comparator | AVD set by taking the larger of 0.50ms or A-V interval 0.70 Receives: Device: CRT device settings |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of CRT atrioventricular delay settings on biochemical markers in blood through 6 months
Measured: end of the study
Secondary outcomes (4)
assess effects of echocardiogram through 6months after CRT on heart failure
Measured: end to study
assess the effects of minnesota Living with heart failure questionaire through 6 months after CRT on heart failure
Measured: end of study
assess effects of six minute hall walk through 6 months after CRt on heart failure
Measured: end of study
assess effects of SDANN through 6 months after CRT on heart failure
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJun 2004
- Primary completionMay 2010
- Study completionNov 2010
Why it stopped: funding difficulty
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 MinnesotaThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Medical Foundation
- Responsible party
- Sponsor
- Investigators
- David G Benditt, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794183
- Sponsor's protocol ID
- 0303M44604
- Acronym
- BRAVO-CRT
- Status last verified
- Jun 2012
- First submitted
- 18 Nov 2008
- Last updated
- 26 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of theRelationship Between Atrio-Ventricular Delay and Changes in Biochemical Markers of Chronic Heart Failure During Cardiac Resynchronization Therapy (BRAVO-CRT)
- ClinicalTrials.gov ID
- NCT00794183
- Acronym / sponsor ID
- BRAVO-CRT / 0303M44604
- Conditions
- Heart Failure
- Keywords
- heart failure, CRT, CHF
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding difficulty
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Minnesota Medical Foundation
- Study start
- Jun 2004
- Primary completion
- May 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Nov 2008 (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 idea of this study is to compare different ways of setting up a pacemaker, using blood tests to give us information about how well it's working. We hope to learn if we can use this approach to figure out the best pacemaker setup ("programming") for each individual patient.
The setting we propose to adjust is the timing between the impulse sent between top and bottom chambers.
Detailed description
There are different kinds of pacemakers and different ways they can be set up to try to make the heart beat regularly. A normal heart has four chambers; these four chambers pump in a co-ordinated way to move blood effectively. When pacemakers were first invented, they told the heart when to pump, but didn't make the four chambers work well together. Newer pacemakers can give more detailed instructions, so the chambers work together more effectively. We already know that the newer (bi-ventricular) pacemakers work better for some patients with heart failure.
There are blood tests (often referred to as "markers") that give us information about how well your heart is working and about how your body is responding to heart failure. The idea of this study is to compare different ways of setting up a pacemaker, using these blood tests to give us information about how well it's working. We hope to learn if we can use this approach to figure out the best pacemaker setup ("programming") for each individual patient.
Usually pacemakers have two wires or leads, one is in the top right chamber and the other in the bottom right chamber of the heart. The newer pacemakers, which are given to patients with heart failure, have an additional lead or wire, which goes to the left side of the heart. So when heart contracts the lead from top chamber sends impulses to bottom chambers and the leads in right and left sides of bottom chamber responds by sending impulses in a co-ordinated way enabling heart to contract efficiently.
Currently, the standard way of treating patients with heart failure is by pacing the top and then bottom chambers, based on a timing interval determined by ultrasound, while also pacing the two bottom chambers in a coordinated manner. There are differences of opinion among experts and by previous studies regarding this method. Pacing is accomplished through pacemaker wires, which are placed in the right top chamber, the right bottom chamber and the left bottom chamber of the heart.
The setting we propose to adjust is the timing between the impulse sent between top and bottom chambers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: CRT device settingsAVD set by taking the larger of 0.50ms or A-V interval 0.30 |
| 2 | Active comparator | Device: CRT device settingsAVD set by taking the larger of 0.50ms or A-V interval 0.50 |
| 3 | Active comparator | Device: CRT device settingsAVD set by taking the larger of 0.50ms or A-V interval 0.70 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of chronic heart failure
- patients on stable pharmacologic therapy for at least 3 months
- EF< 35%
- age >18 years
- NYHA functional class III or IV
Key exclusion criteria (5 listed)
- systolic blood pressure <70mmHg
- Likely to receive a left ventricular assist device or cardiac transplant within 6 months of implant procedure
- patients who have previously received a CRT device
- documented atrial fibrillation
- complete heart block
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 |
|---|---|---|
| CRT device settingsComparision of A-V delay settings | Device | 1, 2, 3 |
Primary outcome
To assess the effect of CRT atrioventricular delay settings on biochemical markers in blood through 6 months
Time frame: end of the study
4 secondary outcomes
assess effects of echocardiogram through 6months after CRT on heart failure
Time frame: end to study
assess the effects of minnesota Living with heart failure questionaire through 6 months after CRT on heart failure
Time frame: end of study
assess effects of six minute hall walk through 6 months after CRt on heart failure
Time frame: end of study
assess effects of SDANN through 6 months after CRT on heart failure
Time frame: end of study
Results and safety
The study was stopped early (reason given: funding difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
David G Benditt, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CRT device settings in people with Heart Failure, run by University of Minnesota 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 8 inclusion and 5 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 26 Jun 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: funding difficulty). Results are not available in the source record.
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?
To assess the effect of CRT atrioventricular delay settings on biochemical markers in blood through 6 months (time frame: end of the study). 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 26 Jun 2012.