Heart FailureNCT06800716
Impella Reverse Remodeling in End-Stage Heart Failure
An observational study of Heart Failure and Cardiomyopathy, run by Columbia University at 1 site in United States.
Trial summary
This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Cardiomyopathy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inpatients at Columbia University Irving Medical Center, who are waitlisted for heart transplant with a clinical indication for Impella 5.5 left ventricular assist device (LVAD) placement.
Who may be able to join
- Age 18 years or older
- Dilated cardiomyopathy (LVEDD > 5.5 cm and LVEF <25%)
- Indication for temporary mechanical circulatory support therapy with Impella 5.5 LVAD as a bridge to transplant or bridge to transplant decision based on treating physician's discretion
Who cannot join
- Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation
- Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation
- Congenital heart disease
- Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis
- Evidence of acute myocarditis by endomyocardial biopsy
- Prior heart transplantation
Show all 20Show fewer
- Mechanical aortic / mitral valve
- Patient with known aortic diseases such as Marfan-Syndrome, Morbus Erdheim-Gsell or others
- Left Ventricular thrombus
- Left Ventricular rupture
- Cardiac tamponade
- Presence of an Atrial or Ventricular Septal Defect
- Severe right ventricular (RV) Failure requiring mechanical RV support
- Severe peripheral vascular disease precluding placement of the Impella System
- Recent stroke resulting in significant neurological deficit
- Hypercoagulable disease precluding device implantation
- Severe thrombocytopenia (<50,000)
- Contraindication to anticoagulation
- Suspected or known pregnancy or lactating women
- Subject belongs to a vulnerable population
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University
New York, New York, 10032
Kate Dalton, MS, (347)514-3366, keb2114@cumc.columbia.edu
Adil Yunis, MD
About this study
Official title: A Prospective Study of Recovery Mechanisms in Heart Transplant Eligible Patients With Cardiogenic Shock on Impella 5.5 Support
This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. There will be two phases of enrollment: First phase will enroll 10 patients; second phase will enroll an additional 40 patients. Approximately 50 participants will take part in the study at Columbia University Irving Medical Center.
Participation in this research is expected to last approximately 14 months. This time estimate includes a screening period for about 1- 3 days, treatment period of 40 days and post treatment follow-up period for 1 year. Data will be collected through 1- year after heart transplant. Clinical data (medical history, vital signs, laboratory assessments) from medical records, to perform functional testing, and to obtain blood and discarded heart tissue fromfor the purpose of this research study.
Participants will be asked to share their records for echocardiography, right heart catheterization, laboratory data and clinical information. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.
Read the detailed description
Percutaneous endovascular mechanical circulatory support (MCS) devices have been increasingly utilized in patients on the waitlist for heart transplantation in the new heart allocation system. However, the number of patients recovering from heart failure and delisted from cardiac transplantation has declined in the new heart allocation system. While significant research has been performed on myocardial recovery with durable left ventricular assist device (LVAD) support, natural course and mechanistic basis of reverse remodeling on percutaneous endovascular MCS remains unknown. The primary objective of this prospective, observational, single-center study is to evaluate whether mechanical circulatory support with Impella 5.5 LVAD in decompensated patients on the waitlist for heart transplantation results in left ventricular reverse remodeling and improvement in end-organ function within 14 days of initiating support. Phenotypic data including clinical information, echocardiography, and hemodynamics will be serially obtained in participants before and after Impella 5.5 LVAD placement. Paired serum samples (pre- and post- Impella support) will be obtained for proteomic analysis. Cardiac tissue samples will be collected at the time of cardiac transplantation for histopathological analysis as well as RNA-sequencing. Candidate genes and proteins of reverse remodeling will be validated using quantitative polymerase chain reaction (qPCR) and Western Blotting. This study will definitively establish the natural course of reverse remodeling in patients with chronically failing ventricles on Impella 5.5 support and determine molecular signals and novel biomarkers of myocardial recovery in this growing population. Data obtained from this study will help determine which patients should pursue recovery pathway as opposed to transplant.
- Conditions
- Heart Failure, Cardiomyopathy
- Keywords
- cardiogenic shock and transplant, impella, LVAD
- Medical subject headings
- Heart Failure, Cardiomyopathies, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Decompensated patients on the waitlist for heart transplantation | Study participants will receive Impella 5.5 LVAD for treatment of cardiogenic shock and transplant listing as standard of care. Clinical data and serum laboratory including blood counts, end-organ function, nutritional parameters will be collected prospectively from medical records. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction (LVEF)
A change in echocardiographic index will be evaluated by measuring a change in LVEF before and after Impella support at minimal pump setting.
Measured: Baseline and approximately Day 40
Change in Left Ventricular End-Diastolic Diameter (LVEDD)
A change in echocardiographic index will be evaluated by measuring a change in LVEDD before and after Impella support at minimal pump setting.
Measured: Baseline and approximately Day 40
Change in Cardiac Index
A change in hemodynamics will be evaluated by measuring a change in cardiac index before and after Impella support at minimal pump speed setting (P2).
Measured: Baseline and approximately Day 40
Change in Pulmonary Capillary Wedge Pressure
A change in hemodynamics will be evaluated by measuring a change in Pulmonary Capillary Wedge Pressure before and after Impella support at minimal pump speed setting (P2).
Measured: Baseline and approximately Day 40
Secondary outcomes (30)
Transplant Waitlist Outcome
The transplant waitlist outcome will be evaluated and the number of participants who die, are delisted due to worsening clinical condition, are transplanted, or are delisted for recovery will be reported.
Measured: 14 months
Number of Participants Escalated
Number of participants escalated to extracorporeal membrane oxygenation (ECMO) or other temporary/durable mechanical circulatory support (MCS).
Measured: 14 months
Waitlist time on Impella Support
Waitlist time on Impella support measured in days from the date of Impella insertion to heart transplantation or other waitlist end-point.
Measured: 14 months
Change in aminoterminal pro B-type natriuretic peptide (NT-proBNP)
Change in NT-proBNP levels collected from blood samples and measured in pg/mL.
Measured: Baseline and approximately Day 40
Change in Blood Urea Nitrogen (BUN)
Change in BUN levels collected from blood samples and measured in mg/dL.
Measured: Baseline and approximately Day 40
Change in Estimated Glomerular Filtration Rate (eGFR)
Change in eGFR collected from blood samples and measured in mL/min/1.73m^2.
Measured: Baseline and approximately Day 40
Change in Cystatin C
Change in Cystatin C collected from blood samples and measured in mg/L.
Measured: Baseline and approximately Day 40
Change in Total Bilirubin
Change in Total Bilirubin collected from blood samples and measured in mg/dL.
Measured: Baseline and approximately Day 40
Change in Aspartate Aminotransferase (AST)
Change in AST collected from blood samples and measured in U/L.
Measured: Baseline and approximately Day 40
Change in Alanine Aminotransferase (ALT)
Change in ALT collected from blood samples and measured in U/L.
Measured: Baseline and approximately Day 40
Change in International Normalized Ratio (INR)
Change in INR collected from blood samples. INR is a ratio and has no units of measure.
Measured: Baseline and approximately Day 40
Change in Hemoglobin
Change in hemoglobin levels collected from blood samples and measured in g/L.
Measured: Baseline and approximately Day 40
Change in Platelet Count
Change in platelet count collected from blood samples and measured in pl/μL.
Measured: Baseline and approximately Day 40
Change in Lactate dehydrogenase (LDH)
Change in LDH collected from blood samples and measured in U/L.
Measured: Baseline and approximately Day 40
Change in Plasma Free Hemoglobin
Change in plasma free hemoglobin collected from blood samples and measured in mg/dL.
Measured: Baseline and approximately Day 40
Change in Prealbumin
Change in prealbumin collected from blood samples and measured in mg/dL.
Measured: Baseline and approximately Day 40
Change in Albumin
Change in albumin collected from blood samples and measured in mg/dL.
Measured: Baseline and approximately Day 40
Change in C-Reactive Protein (CRP)
Change in CRP collected from blood samples and measured in mg/L.
Measured: Baseline and approximately Day 40
Change in Erythrocyte Sedimentation Rate (ESR)
Change in ESR collected from blood samples and measured in mm/hr.
Measured: Baseline and approximately Day 40
Change in Procalcitonin
Change in procalcitonin collected from blood samples and measured in ng/mL.
Measured: Baseline and approximately Day 40
Change in HLA Allosensitization Profile
Change in the HLA allosensitization profile. Allosensitization is the presence of circulating antibodies against human leukocyte antigens and nonhuman leukocyte antigens.
Measured: Baseline and approximately Day 40
Change in Vasoactive-Inotropic Score (VIS)
Vasoactive-Inotropic Score (VIS) is calculated with the following formula: VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min). Scores range from 0 to no upper limit, with a higher score indicating a worse outcome.
Measured: Baseline and approximately Day 40
Six Minute Walk Test (6MWT)
The 6MWT is a measure of performance that assesses the distance walked in six minutes measured in meters. the 6MWT will be conducted in the Cardiac Care Unit (CCU) on device support.
Measured: 14 months
Change in Upper Extremity Hand Strength
Change in upper extremity strength measured by Handgrip dynamometry in kilograms.
Measured: 14 months
Units of Blood Used During Heart Transplant
Units of red blood cells, cryoprecipitate, fresh frozen plasma, and platelets used during transplant.
Measured: Day of Transplant (Approximately Day 40)
Primary Graft Failure
The number of participants with primary graft failure after heart transplantation. Graft failure defined as left ventricular ejection fraction of <40%.
Measured: 14 months
Early Transplant Rejection
The number of participants with early transplant rejection. Early transplant rejected defined as an episode of rejection within the first 3 months of transplant.
Measured: 14 months
AlloMap Score
AlloMap score after heart transplantation. AlloMap measures the risk of acute cellular rejection. Scores range from 0 - 40 with higher score indicating a worse outcome.
Measured: After Transplant, approximately Day 40
Allosure Score
Allosure score after heart transplantation. Allosure measures the risk of rejection in heart transplant recipients. Scores range from a lower limit of < 0.04 and above with a higher score indicating a worse outcome.
Measured: After Transplant, approximately Day 40
Post-Transplant Length of Stay
Post-transplant length of hospital stay measured in days and assessed for up to 14 months.
Measured: Up to 14 months (approximately 420 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start4 Dec 2024
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
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 Columbia 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Abiomed Inc.
- Responsible party
- Principal investigator, Adil A Yunis, MD, Columbia University
- Investigators
- Adil Yunis, MS, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800716
- Sponsor's protocol ID
- AAAV1201
- Status last verified
- Aug 2026
- First submitted
- 8 Jan 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Recovery Mechanisms in Heart Transplant Eligible Patients With Cardiogenic Shock on Impella 5.5 Support
- ClinicalTrials.gov ID
- NCT06800716
- Acronym / sponsor ID
- AAAV1201
- Conditions
- Heart Failure, Cardiomyopathy
- Keywords
- cardiogenic shock and transplant, impella, LVAD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Abiomed Inc.
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 30 Jan 2025 (actual)
- 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.
This observational study is being done to learn more about heart attack recovery in patients supported with the Impella 5.5 left ventricular assist device (LVAD) as part of their standard of care. There are three stages in this study: screening, treatment and post treatment. There will be two phases of enrollment: First phase will enroll 10 patients; second phase will enroll an additional 40 patients. Approximately 50 participants will take part in the study at Columbia University Irving Medical Center.
Participation in this research is expected to last approximately 14 months. This time estimate includes a screening period for about 1- 3 days, treatment period of 40 days and post treatment follow-up period for 1 year. Data will be collected through 1- year after heart transplant. Clinical data (medical history, vital signs, laboratory assessments) from medical records, to perform functional testing, and to obtain blood and discarded heart tissue fromfor the purpose of this research study.
Participants will be asked to share their records for echocardiography, right heart catheterization, laboratory data and clinical information. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test.
Detailed description
Percutaneous endovascular mechanical circulatory support (MCS) devices have been increasingly utilized in patients on the waitlist for heart transplantation in the new heart allocation system. However, the number of patients recovering from heart failure and delisted from cardiac transplantation has declined in the new heart allocation system. While significant research has been performed on myocardial recovery with durable left ventricular assist device (LVAD) support, natural course and mechanistic basis of reverse remodeling on percutaneous endovascular MCS remains unknown. The primary objective of this prospective, observational, single-center study is to evaluate whether mechanical circulatory support with Impella 5.5 LVAD in decompensated patients on the waitlist for heart transplantation results in left ventricular reverse remodeling and improvement in end-organ function within 14 days of initiating support. Phenotypic data including clinical information, echocardiography, and hemodynamics will be serially obtained in participants before and after Impella 5.5 LVAD placement. Paired serum samples (pre- and post- Impella support) will be obtained for proteomic analysis. Cardiac tissue samples will be collected at the time of cardiac transplantation for histopathological analysis as well as RNA-sequencing. Candidate genes and proteins of reverse remodeling will be validated using quantitative polymerase chain reaction (qPCR) and Western Blotting. This study will definitively establish the natural course of reverse remodeling in patients with chronically failing ventricles on Impella 5.5 support and determine molecular signals and novel biomarkers of myocardial recovery in this growing population. Data obtained from this study will help determine which patients should pursue recovery pathway as opposed to transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decompensated patients on the waitlist for heart transplantation | – | –Study participants will receive Impella 5.5 LVAD for treatment of cardiogenic shock and transplant listing as standard of care. Clinical data and serum laboratory including blood counts, end-organ function, nutritional parameters will be collected prospectively from medical records. Participants are required to complete an assessment a 6-minute walk, and hand grip strength test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients at Columbia University Irving Medical Center, who are waitlisted for heart transplant with a clinical indication for Impella 5.5 left ventricular assist device (LVAD) placement.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Dilated cardiomyopathy (LVEDD > 5.5 cm and LVEF <25%)
- Indication for temporary mechanical circulatory support therapy with Impella 5.5 LVAD as a bridge to transplant or bridge to transplant decision based on treating physician's discretion
Key exclusion criteria (20 listed)
- Intra-aortic balloon pump (IABP) use for more than 7 days at the time of Impella 5.5 implantation
- Percutaneous mechanical circulatory support device, extracorporeal membrane oxygenation (ECMO) or paracorporeal ventricular assist device (VAD) support prior to Impella 5.5 implantation
- Congenital heart disease
- Restrictive or hypertrophic Cardiomyopathy including hypertrophic obstructive cardiomyopathy (HOCM) Amyloidosis, and Sarcoidosis
- Evidence of acute myocarditis by endomyocardial biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline and approximately Day 40
A change in echocardiographic index will be evaluated by measuring a change in LVEF before and after Impella support at minimal pump setting.
Change in Left Ventricular End-Diastolic Diameter (LVEDD)
Time frame: Baseline and approximately Day 40
A change in echocardiographic index will be evaluated by measuring a change in LVEDD before and after Impella support at minimal pump setting.
Change in Cardiac Index
Time frame: Baseline and approximately Day 40
A change in hemodynamics will be evaluated by measuring a change in cardiac index before and after Impella support at minimal pump speed setting (P2).
Change in Pulmonary Capillary Wedge Pressure
Time frame: Baseline and approximately Day 40
A change in hemodynamics will be evaluated by measuring a change in Pulmonary Capillary Wedge Pressure before and after Impella support at minimal pump speed setting (P2).
30 secondary outcomes
Transplant Waitlist Outcome
Time frame: 14 months
Number of Participants Escalated
Time frame: 14 months
Waitlist time on Impella Support
Time frame: 14 months
Change in aminoterminal pro B-type natriuretic peptide (NT-proBNP)
Time frame: Baseline and approximately Day 40
Change in Blood Urea Nitrogen (BUN)
Time frame: Baseline and approximately Day 40
Change in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline and approximately Day 40
Change in Cystatin C
Time frame: Baseline and approximately Day 40
Change in Total Bilirubin
Time frame: Baseline and approximately Day 40
Change in Aspartate Aminotransferase (AST)
Time frame: Baseline and approximately Day 40
Change in Alanine Aminotransferase (ALT)
Time frame: Baseline and approximately Day 40
Change in International Normalized Ratio (INR)
Time frame: Baseline and approximately Day 40
Change in Hemoglobin
Time frame: Baseline and approximately Day 40
Change in Platelet Count
Time frame: Baseline and approximately Day 40
Change in Lactate dehydrogenase (LDH)
Time frame: Baseline and approximately Day 40
Change in Plasma Free Hemoglobin
Time frame: Baseline and approximately Day 40
Change in Prealbumin
Time frame: Baseline and approximately Day 40
Change in Albumin
Time frame: Baseline and approximately Day 40
Change in C-Reactive Protein (CRP)
Time frame: Baseline and approximately Day 40
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline and approximately Day 40
Change in Procalcitonin
Time frame: Baseline and approximately Day 40
Change in HLA Allosensitization Profile
Time frame: Baseline and approximately Day 40
Change in Vasoactive-Inotropic Score (VIS)
Time frame: Baseline and approximately Day 40
Six Minute Walk Test (6MWT)
Time frame: 14 months
Change in Upper Extremity Hand Strength
Time frame: 14 months
Units of Blood Used During Heart Transplant
Time frame: Day of Transplant (Approximately Day 40)
Primary Graft Failure
Time frame: 14 months
Early Transplant Rejection
Time frame: 14 months
AlloMap Score
Time frame: After Transplant, approximately Day 40
Allosure Score
Time frame: After Transplant, approximately Day 40
Post-Transplant Length of Stay
Time frame: Up to 14 months (approximately 420 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- 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.
Adil Yunis, MS 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?
An observational study of Heart Failure and Cardiomyopathy, run by Columbia 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 3 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adil Yunis, MD (212-305-0211, aay2122@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (LVEF) (time frame: Baseline and approximately Day 40). The study lists 4 primary outcomes in all. 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 19 Aug 2026.