Acute on Chronic Systolic Congestive Heart FailureNCT02652676
Reversible Pulmonary Artery Banding as Simplified Management of End-stage Dilated Left Ventriculopathy in Early Life
A study testing Reversible Pulmonary Artery Banding and GORE-TEX DualMesh EMERGE PLUS Biomaterial in people with Acute on Chronic Systolic Congestive Heart Failure, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this study is to: 1) Remodel and restore left ventricular geometry and function. 2) Avoid the need for mechanical circulatory support (MCS) and/or cardiac transplantation (CT). Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Acute on Chronic Systolic Congestive Heart Failure
- What is being tested?
- Reversible Pulmonary Artery Banding and GORE-TEX DualMesh EMERGE PLUS Biomaterial
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 7 May 2021
- Phase
- Interventional
- 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 Up to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 0-4 years
- Isolated, idiopathic left-ventricular end-stage dilated cardiomyopathy or a Left Ventricular End-Diastolic Diameter (LVEDD) Z-score > 4.5; Ejection Fraction (EF) < 30%
- Acceptable candidate for mechanical circulatory support and/or cardiac transplantation
- Preserved right-ventricular function
- Clinical functional status IV (hospitalized)
- Parental consent
Who cannot join
- Biventricular end-stage dilated cardiomyopathy
- Proven or suspected myocarditis
- Concomitant structural (congenital) heart disease
- Moderate-severe tricuspid valve regurgitation
- Pulmonary hypertension out of proportion with left-ventricular end-stage cardiomyopathy
- Hereditary disease associated with bi-ventricular dysfunction
- Age greater than 4 years
- No parental consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Children's Hospital
Loma Linda, California, 92354
About this study
The purpose of this study is to: 1) Remodel and restore left ventricular geometry and function. 2) Avoid the need for mechanical circulatory support (MCS) and/or cardiac transplantation (CT). 3) Confirm the outcomes of a pilot study completed in Germany and reported in The Journal of Heart and Lung Transplantation in May 2013.
Read the detailed description
The study infant will undergo cardiac catheterization and myocardial biopsy before pulmonary artery banding and at appropriate intervals during follow-up surveillance by the interventional cardiologist. Patients will be "listed" for heart transplantation, and rPAB will be applied in lieu of mechanical circulatory support or as an alternative to already existing mechanical circulatory support, in the form of extracorporeal mechanical oxygen (ECMO). Myocardial biopsies will be flash frozen for storage and eventual probing for cell type (mature or stem) as part of a separate study.
The addition of afterload rPAB to a normal-functioning right ventricle (in the setting of end-stage dilated cardiomyopathy) shifts the inter-ventricular septum toward the midline, thus significantly improving left ventricular geometry and function. It permits the infant or young child to operate from a much improved position on Starling's curve with gradual resolution of congestive heart failure and the potential for lethal ventricular dysrhythmia. An abundance of progenitor myocytes known to exist within the myocardium of this patient age group may then contribute to "permanent" left ventricular restoration.
A sternotomy incision is used for application of the rPAB. The band is tightened under echocardiographic control until the inter-ventricular septum becomes a midline structure. Myocardial function is augmented with inotropic and vasodilator agents. These agents are weaned off gradually over a period of 2-4 weeks. The infant is separated from mechanical ventilation within the first post-rPAB week, and enteric feeding is resumed. The infant is discharged on oral medications, and is kept under frequent clinical surveillance.
As the infant grows, the rPAB becomes relatively more obstructive to right ventricular outflow. Based on a finding of increasing right ventricular dilation, onset or worsening tricuspid valve regurgitation, or a gradual late increase in plasma B-type natriuretic peptide (BNP) levels, the band may be loosened in stages as a balloon catheter-based procedure. Band enlargement may be accomplished in stages, ultimately opting for a mild residual right ventricle-main pulmonary artery pressure gradient of 15-30 mmHg.
The infants' short- and long-term surveillance will include clinical examination, height, weight, cardiac catheterization, electrocardiogram, echocardiogram, chest x-ray, and plasma BNP levels.
- Being tested
- Reversible Pulmonary Artery Banding, GORE-TEX DualMesh EMERGE PLUS Biomaterial
- Keywords
- Infant Cardiac Transplantation, End-stage Idiopathic Dilated Cardiomyopathy, Mechanical Circulatory Device, End Stage Dilated Left Ventriculopathy, Acute-on-Chronic Left Ventricular Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reversible Pulmonary Artery BandingProcedure or surgery
Also called rPAB
A sternotomy incision is used for application of the rPAB. Tightening is under echocardiographic control until the inter-ventricular septum becomes a midline structure. Myocardial function is augmented with inotropic and vasodilator agents that are weaned after 2-4 weeks. The infant is separated from mechanical ventilation within the first week, and enteric feeding is resumed. The infant is discharged on oral medications, with follow-ups. Band enlargement is in stages as a balloon catheter-based procedure if a finding of increasing right ventricular dilation, onset or worsening tricuspid valve regurgitation, or a gradual late increase in plasma B-type natriuretic peptide (BNP) levels, opting for a mild residual right ventricle-main pulmonary artery pressure gradient of 15-30 mmHg.
GORE-TEX DualMesh EMERGE PLUS BiomaterialProcedure or surgery
Also called Gortex Cardiovascular Patch
The study is being conducted to evaluate the procedure, not the materials being used. The study uses the patch as materials to create the band around the pulmonary artery which is currently done routinely off label. The patch is approved as a cardiovascular patch. FDA 501(k) K032168.
| Study group | Role | What they receive |
|---|---|---|
| Reversible Pulmonary Artery Banding Procedure | Experimental | The addition of afterload Reversible Pulmonary Artery Banding to a normal-functioning right ventricle (in the setting of end-stage dilated cardiomyopathy) shifts the inter-ventricular septum toward the midline, thus significantly improving left ventricular geometry and function. It permits the infant or young child to operate from a much improved position on Starling's curve with gradual resolution of congestive heart failure and the potential for lethal ventricular dysrhythmia. An abundance of progenitor myocytes known to exist within the myocardium of this patient age group may then contribute to "permanent" left ventricular restoration. Receives: Procedure: Reversible Pulmonary Artery Banding; Procedure: GORE-TEX DualMesh EMERGE PLUS Biomaterial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Success
positive surgical outcome, the survival of the patient, the lack of a need for mechanical circulatory support or heart transplant, and improved left ventricular function
Measured: 5 years
Secondary outcomes (2)
All Cause Mortality
Total number of deaths due to non-cardiac open vs minimally invasive thoracic surgery.
Measured: 5 years
Persistent Heart Failure
Described as having an NYHA of greater than II.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute on Chronic Systolic Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Martens, MD, PhD, Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652676
- Sponsor's protocol ID
- 5150418
- Status last verified
- Feb 2023
- First submitted
- 8 Jan 2016
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arbustini E, Weidemann F, Hall JL. Left ventricular noncompaction: a distinct cardiomyopathy or a trait shared by different cardiac diseases? J Am Coll Cardiol. 2014 Oct 28;64(17):1840-50. doi: 10.1016/j.jacc.2014.08.030. Epub 2014 Oct 21.
PubMed 25443708Bailey LL. Back to the future! Bold new indication for pulmonary artery banding. J Heart Lung Transplant. 2013 May;32(5):482-3. doi: 10.1016/j.healun.2013.03.001. No abstract available.
PubMed 23570740Brancaccio G, Amodeo A, Ricci Z, Morelli S, Gagliardi MG, Iacobelli R, Michielon G, Picardo S, Parisi F, Pongiglione G, Di Donato RM. Mechanical assist device as a bridge to heart transplantation in children less than 10 kilograms. Ann Thorac Surg. 2010 Jul;90(1):58-62. doi: 10.1016/j.athoracsur.2010.03.056.
PubMed 20609748Everett BM, Berger JS, Manson JE, Ridker PM, Cook NR. B-type natriuretic peptides improve cardiovascular disease risk prediction in a cohort of women. J Am Coll Cardiol. 2014 Oct 28;64(17):1789-97. doi: 10.1016/j.jacc.2014.04.089. Epub 2014 Oct 21.
PubMed 25443700Julious SA. Two-sided confidence intervals for the single proportion: comparison of seven methods by Robert G. Newcombe, Statistics in Medicine 1998; 17:857-872. Stat Med. 2005 Nov 15;24(21):3383-4. doi: 10.1002/sim.2164. No abstract available.
PubMed 16206245Miyamoto SD, Karimpour-Fard A, Peterson V, Auerbach SR, Stenmark KR, Stauffer BL, Sucharov CC. Circulating microRNA as a biomarker for recovery in pediatric dilated cardiomyopathy. J Heart Lung Transplant. 2015 May;34(5):724-33. doi: 10.1016/j.healun.2015.01.979. Epub 2015 Jan 30.
PubMed 25840506Ross RD. The Ross classification for heart failure in children after 25 years: a review and an age-stratified revision. Pediatr Cardiol. 2012 Dec;33(8):1295-300. doi: 10.1007/s00246-012-0306-8. Epub 2012 Apr 5.
PubMed 22476605Schranz D, Veldman A, Bartram U, Michel-Behnke I, Bauer J, Akinturk H. Pulmonary artery banding for idiopathic dilative cardiomyopathy: a novel therapeutic strategy using an old surgical procedure. J Thorac Cardiovasc Surg. 2007 Sep;134(3):796-7. doi: 10.1016/j.jtcvs.2007.04.044. No abstract available.
PubMed 17723838Schranz D, Rupp S, Muller M, Schmidt D, Bauer A, Valeske K, Michel-Behnke I, Jux C, Apitz C, Thul J, Hsu D, Akinturk H. Pulmonary artery banding in infants and young children with left ventricular dilated cardiomyopathy: a novel therapeutic strategy before heart transplantation. J Heart Lung Transplant. 2013 May;32(5):475-81. doi: 10.1016/j.healun.2013.01.988. Epub 2013 Feb 12.
PubMed 23410738
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversible Pulmonary Artery Banding as Simplified Management of End-stage Dilated Left Ventriculopathy in Early Life
- ClinicalTrials.gov ID
- NCT02652676
- Acronym / sponsor ID
- 5150418
- Keywords
- Infant Cardiac Transplantation, End-stage Idiopathic Dilated Cardiomyopathy, Mechanical Circulatory Device, End Stage Dilated Left Ventriculopathy, Acute-on-Chronic Left Ventricular Failure
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 12 Jan 2016 (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 purpose of this study is to: 1) Remodel and restore left ventricular geometry and function. 2) Avoid the need for mechanical circulatory support (MCS) and/or cardiac transplantation (CT). 3) Confirm the outcomes of a pilot study completed in Germany and reported in The Journal of Heart and Lung Transplantation in May 2013.
Detailed description
The study infant will undergo cardiac catheterization and myocardial biopsy before pulmonary artery banding and at appropriate intervals during follow-up surveillance by the interventional cardiologist. Patients will be "listed" for heart transplantation, and rPAB will be applied in lieu of mechanical circulatory support or as an alternative to already existing mechanical circulatory support, in the form of extracorporeal mechanical oxygen (ECMO). Myocardial biopsies will be flash frozen for storage and eventual probing for cell type (mature or stem) as part of a separate study.
The addition of afterload rPAB to a normal-functioning right ventricle (in the setting of end-stage dilated cardiomyopathy) shifts the inter-ventricular septum toward the midline, thus significantly improving left ventricular geometry and function. It permits the infant or young child to operate from a much improved position on Starling's curve with gradual resolution of congestive heart failure and the potential for lethal ventricular dysrhythmia. An abundance of progenitor myocytes known to exist within the myocardium of this patient age group may then contribute to "permanent" left ventricular restoration.
A sternotomy incision is used for application of the rPAB. The band is tightened under echocardiographic control until the inter-ventricular septum becomes a midline structure. Myocardial function is augmented with inotropic and vasodilator agents. These agents are weaned off gradually over a period of 2-4 weeks. The infant is separated from mechanical ventilation within the first post-rPAB week, and enteric feeding is resumed. The infant is discharged on oral medications, and is kept under frequent clinical surveillance.
As the infant grows, the rPAB becomes relatively more obstructive to right ventricular outflow. Based on a finding of increasing right ventricular dilation, onset or worsening tricuspid valve regurgitation, or a gradual late increase in plasma B-type natriuretic peptide (BNP) levels, the band may be loosened in stages as a balloon catheter-based procedure. Band enlargement may be accomplished in stages, ultimately opting for a mild residual right ventricle-main pulmonary artery pressure gradient of 15-30 mmHg.
The infants' short- and long-term surveillance will include clinical examination, height, weight, cardiac catheterization, electrocardiogram, echocardiogram, chest x-ray, and plasma BNP levels.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reversible Pulmonary Artery Banding Procedure | Experimental | Procedure: Reversible Pulmonary Artery Banding, Procedure: GORE-TEX DualMesh EMERGE PLUS BiomaterialThe addition of afterload Reversible Pulmonary Artery Banding to a normal-functioning right ventricle (in the setting of end-stage dilated cardiomyopathy) shifts the inter-ventricular septum toward the midline, thus significantly improving left ventricular geometry and function. It permits the infant or young child to operate from a much improved position on Starling's curve with gradual resolution of congestive heart failure and the potential for lethal ventricular dysrhythmia. An abundance of progenitor myocytes known to exist within the myocardium of this patient age group may then contribute to "permanent" left ventricular restoration. |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 0-4 years
- Isolated, idiopathic left-ventricular end-stage dilated cardiomyopathy or a Left Ventricular End-Diastolic Diameter (LVEDD) Z-score > 4.5; Ejection Fraction (EF) < 30%
- Acceptable candidate for mechanical circulatory support and/or cardiac transplantation
- Preserved right-ventricular function
- Clinical functional status IV (hospitalized)
Key exclusion criteria (8 listed)
- Biventricular end-stage dilated cardiomyopathy
- Proven or suspected myocarditis
- Concomitant structural (congenital) heart disease
- Moderate-severe tricuspid valve regurgitation
- Pulmonary hypertension out of proportion with left-ventricular end-stage cardiomyopathy
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 |
|---|---|---|
| Reversible Pulmonary Artery BandingAlso: rPABA sternotomy incision is used for application of the rPAB. Tightening is under echocardiographic control until the inter-ventricular septum becomes a midline structure. Myocardial function is augmented with inotropic and vasodilator agents that are weaned after 2-4 weeks. The infant is separated from mechanical ventilation within the first week, and enteric feeding is resumed. The infant is discharged on oral medications, with follow-ups. Band enlargement is in stages as a balloon catheter-based procedure if a finding of increasing right ventricular dilation, onset or worsening tricuspid valve regurgitation, or a gradual late increase in plasma B-type natriuretic peptide (BNP) levels, opting for a mild residual right ventricle-main pulmonary artery pressure gradient of 15-30 mmHg. | Procedure or surgery | Reversible Pulmonary Artery Banding Procedure |
| GORE-TEX DualMesh EMERGE PLUS BiomaterialAlso: Gortex Cardiovascular PatchThe study is being conducted to evaluate the procedure, not the materials being used. The study uses the patch as materials to create the band around the pulmonary artery which is currently done routinely off label. The patch is approved as a cardiovascular patch. FDA 501(k) K032168. | Procedure or surgery | Reversible Pulmonary Artery Banding Procedure |
Primary outcome
Surgical Success
Time frame: 5 years
positive surgical outcome, the survival of the patient, the lack of a need for mechanical circulatory support or heart transplant, and improved left ventricular function
2 secondary outcomes
All Cause Mortality
Time frame: 5 years
Persistent Heart Failure
Time frame: 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Background: PubMed 25443708Arbustini E, Weidemann F, Hall JL. Left ventricular noncompaction: a distinct cardiomyopathy or a trait shared by different cardiac diseases? J Am Coll Cardiol. 2014 Oct 28;64(17):1840-50. doi: 10.1016/j.jacc.2014.08.030. Epub 2014 Oct 21.
- Background: PubMed 23570740Bailey LL. Back to the future! Bold new indication for pulmonary artery banding. J Heart Lung Transplant. 2013 May;32(5):482-3. doi: 10.1016/j.healun.2013.03.001. No abstract available.
- Background: PubMed 20609748Brancaccio G, Amodeo A, Ricci Z, Morelli S, Gagliardi MG, Iacobelli R, Michielon G, Picardo S, Parisi F, Pongiglione G, Di Donato RM. Mechanical assist device as a bridge to heart transplantation in children less than 10 kilograms. Ann Thorac Surg. 2010 Jul;90(1):58-62. doi: 10.1016/j.athoracsur.2010.03.056.
- Background: PubMed 25443700Everett BM, Berger JS, Manson JE, Ridker PM, Cook NR. B-type natriuretic peptides improve cardiovascular disease risk prediction in a cohort of women. J Am Coll Cardiol. 2014 Oct 28;64(17):1789-97. doi: 10.1016/j.jacc.2014.04.089. Epub 2014 Oct 21.
- Background: PubMed 16206245Julious SA. Two-sided confidence intervals for the single proportion: comparison of seven methods by Robert G. Newcombe, Statistics in Medicine 1998; 17:857-872. Stat Med. 2005 Nov 15;24(21):3383-4. doi: 10.1002/sim.2164. No abstract available.
- Background: PubMed 25840506Miyamoto SD, Karimpour-Fard A, Peterson V, Auerbach SR, Stenmark KR, Stauffer BL, Sucharov CC. Circulating microRNA as a biomarker for recovery in pediatric dilated cardiomyopathy. J Heart Lung Transplant. 2015 May;34(5):724-33. doi: 10.1016/j.healun.2015.01.979. Epub 2015 Jan 30.
- Background: PubMed 22476605Ross RD. The Ross classification for heart failure in children after 25 years: a review and an age-stratified revision. Pediatr Cardiol. 2012 Dec;33(8):1295-300. doi: 10.1007/s00246-012-0306-8. Epub 2012 Apr 5.
- Background: PubMed 17723838Schranz D, Veldman A, Bartram U, Michel-Behnke I, Bauer J, Akinturk H. Pulmonary artery banding for idiopathic dilative cardiomyopathy: a novel therapeutic strategy using an old surgical procedure. J Thorac Cardiovasc Surg. 2007 Sep;134(3):796-7. doi: 10.1016/j.jtcvs.2007.04.044. No abstract available.
- Background: PubMed 23410738Schranz D, Rupp S, Muller M, Schmidt D, Bauer A, Valeske K, Michel-Behnke I, Jux C, Apitz C, Thul J, Hsu D, Akinturk H. Pulmonary artery banding in infants and young children with left ventricular dilated cardiomyopathy: a novel therapeutic strategy before heart transplantation. J Heart Lung Transplant. 2013 May;32(5):475-81. doi: 10.1016/j.healun.2013.01.988. Epub 2013 Feb 12.
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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.
Timothy Martens, MD, PhD principal investigator
Loma Linda University 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 Reversible Pulmonary Artery Banding and GORE-TEX DualMesh EMERGE PLUS Biomaterial in people with Acute on Chronic Systolic Congestive Heart Failure, run by Loma Linda University 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 6 inclusion and 8 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 10 Feb 2023. 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 was stopped early. 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?
Surgical Success (time frame: 5 years). 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 NCT02652676, which also lists 9 linked publications.
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 10 Feb 2023.