Heart FailureNCT03001674
Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
A study testing Conductance catheterization in people with Heart Failure, run by Tufts Medical Center at 1 site in United States.
Trial summary
The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Conductance catheterization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2015
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or females between 18-75 years of age
- NYHA Class III-IV heart failure at the time of MEGA deployment
- Stage C-D systolic heart failure
- Non-ischemic cardiomyopathy
- Preserved right ventricular function defined by 2D-echocardiography
- Clinically indicated left and right heart catheterization and MEGA-IABP placement
- Clinically indicated MEGA-IABP support for 12 hours minimum
Who cannot join
- Ischemic cardiomyopathy
- Active myocardial ischemia or acute coronary syndrome
- Severe peripheral vascular disease
- Severe aortic or mitral valve insufficiency
- Severe aortic or mitral valve stenosis
- Right ventricular failure
Show all 14Show fewer
- Inability to tolerate left and right heart catheterization
- Severe hemodynamic instability defined as a systolic BP <80mmHg despite vasopressor/inotropic support
- Sustained ventricular tachycardia (>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours
- Pacemaker dependent rhythm
- Left ventricular thrombus
- Rapid atrial fibrillation (HR>120 bpm)
- Unable to provide informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses.
- Conditions
- Heart Failure
- Being tested
- Conductance catheterization
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conductance catheterizationDevice
CD Leycom Conductance Catheter
| Study group | Role | What they receive |
|---|---|---|
| IABP recipient | Experimental | Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery. Receives: Device: Conductance catheterization |
| Control | Experimental | Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled. Receives: Device: Conductance catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.
We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Navin Kapur, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001674
- Sponsor's protocol ID
- IABP_Hemodynamics
- Status last verified
- Apr 2017
- First submitted
- 27 Mar 2014
- Last updated
- 31 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT03001674
- Acronym / sponsor ID
- IABP_Hemodynamics
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Dec 2016 (estimated)
- Results
- Posted 31 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IABP recipient | Experimental | Device: Conductance catheterizationReferred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery. |
| Control | Experimental | Device: Conductance catheterizationControl subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or females between 18-75 years of age
- NYHA Class III-IV heart failure at the time of MEGA deployment
- Stage C-D systolic heart failure
- Non-ischemic cardiomyopathy
- Preserved right ventricular function defined by 2D-echocardiography
Key exclusion criteria (14 listed)
- Ischemic cardiomyopathy
- Active myocardial ischemia or acute coronary syndrome
- Severe peripheral vascular disease
- Severe aortic or mitral valve insufficiency
- Severe aortic or mitral valve stenosis
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 |
|---|---|---|
| Conductance catheterizationCD Leycom Conductance Catheter | Device | Control, IABP recipient |
Primary outcome
Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.
Time frame: 24 hours
We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Navin Kapur, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conductance catheterization in people with Heart Failure, run by Tufts 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 7 inclusion and 14 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 31 May 2017. 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 31 May 2017). 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?
Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work. (time frame: 24 hours). 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 31 May 2017.