Heart FailureINTeGRATENCT06965504
INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery
A study testing Impella 5.5 SmartAssist in people with Heart Failure and Cardiogenic Shock, run by Abiomed Inc. at 17 sites in United States.
Trial summary
The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure
- What is being tested?
- Impella 5.5 SmartAssist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 17 sitesUnited States
- Study dates
- 2 Oct 2026to 1 Jun 2029
- Phase
- Interventional
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and < 80 years
- Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form
- LVEF ≤ 40%
- Subject is presenting with decompensated heart failure and meets at least two (2) of the following cardiogenic shock criteria:
- Hypotension (sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for inotropic/vasoactive agents to maintain such blood pressure)
- Hypoperfusion (physical sign(s) of organ hypoperfusion or serum lactate >2 mmol/L)
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- Cardiac index (CI) < 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
- Required support with an intra-aortic balloon pump (IABP) or Impella CP™
- Subject has inadequate heart failure GDMT based on the most recent outpatient prescription prior to index admission, defined as:
- On 2 or less of the 4-Pillar HF Drug Classes (BB, MRA, SGLT2i, and RASi)
- If on BB and RASi, at least one of the two medications is < 50% of the maximal target dose
Who cannot join
- Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to:
- Drug allergies or hypersensitivities* to HF GDMT medications, unless alternative can be identified
- Drug allergy/hypersensitivity is an immune-mediated reaction to a medication. Adverse reactions must be a result of immune or inflammatory cell stimulations by the mеԁiсаtion.
- Known bilateral renal artery stenosis
- Type 1 diabetes
- 2o or 3o AV block, unless pacemaker is in place
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- Angioedema, hereditary or idiopathic
- Pregnancy, known or confirmed by a pregnancy test if of childbearing potential
- ST-segment elevation or acute coronary syndrome (ACS) prior to enrollment
- Septic shock, shock from non-cardiac origins, or mixed shock
- SCAI Stage E cardiogenic shock per study definition (Appendix C) prior to enrollment
- In cardiac arrest prior to enrollment
- Prolonged use (or use with complication) of Intra-aortic balloon pump (IABP) or Impella CP™ prior to enrollment, meeting at least one of the following:
- IABP use >24 hours if placed at the enrolling site or >48 hours if transferred on IABP
- Impella CP™ use >24 hours if placed at the enrolling site or >48 hours if transferred on Impella CP™
- Experienced complication(s) from IABP including clinically significant vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion
- Experienced complication(s) from Impella CP™ including clinically significant hemolysis, vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion
- On mechanical circulatory support other than IABP or Impella CP™ (i.e. ECMO, etc) or on mechanical ventilation for non-procedural reasons prior to enrollment
- Revascularization or cardiac surgery within 30-days prior to enrollment
- Infiltrative/restrictive cardiomyopathy (sarcoidosis and amyloidosis), hypertrophic cardiomyopathy, constrictive pericarditis, pericardiac tamponade, or myocarditis requiring high-dose immunosuppression
- Complex adult congenital heart disease
- Primary severe valvular disease
- Predominant RV dysfunction per Investigator's discretion
- History of heart transplant or listed for heart transplant or planned for heart transplantation prior to enrollment
- Planned to be implanted with a permanent VAD within 180-days of the index hospitalization date
- Continuous outpatient inotropic support prior to the index hospitalization date
- Planned to pursue palliative care or hospice, or life expectancy of less than 1 year due to non-cardiac illness at the time of index hospitalization date
- Currently on dialysis, or has pre-existing end-stage chronic kidney disease (stage 4 and above), or has nephropathy of hereditary, infectious, or autoimmune origin
- Pre-existing functional liver disease including liver cirrhosis, alcoholic hepatitis, metabolic dysfunction associated steatohepatitis (MASH), or genetic liver disease
- Pre-existing pulmonary disease with oxygen dependency
- History of stroke or intracranial hemorrhage ≤ 90 days prior to the index hospitalization date, or a history of cerebrovascular disease with significant (> 80%) uncorrected carotid stenosis, or any permanent neurological deficit with modified Rankin Scale (mRS) >2
- Any contraindication that precludes placing an Impella 5.5™, including but not limited to:
- Aortic valve stenosis/calcification with orifice area ≤ 0.6cm2 or aortic insufficiency of any grade greater than mild on pre-procedure echocardiography
- Presence of mechanical aortic valve or heart constrictive device
- Mural thrombus in the left ventricle
- Severe arterial disease precluding placement of Impella
- Presence of atrial or ventricular septal defect
- Left ventricular rupture
- Cardiac tamponade
- Combined cardiorespiratory failure
- Infection of the planned procedural access site or systemic active infection including sepsis and bacteremia
- Intolerance to anticoagulant or antiplatelet therapies, or will refuse blood transfusions
- Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
- Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device
- Subject belongs to a vulnerable population, such as prisoners, pregnant women, handicapped, mentally disabled persons, or economically or educationally disadvantaged persons per 21CFR56.111(a)(3) and 111(b)
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 17 recruiting
- Not yet recruiting
Atrium Health- Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
Haley Bonilla, 704-468-3193, haley.bonilla@atriumhealth.org
Priyesh Patel, M.D.
- Not yet recruiting
Medical City Heart Hospital Dallas
Dallas, Texas, 75243
Lauren Horton, 469-887-3274, lauren.horton2@hcahealthcare.com
Song Li, MD
- Not yet recruiting
Duke University
Durham, North Carolina, 27710
Elyse Wilson, (919) 681-8879, elyse.wilson@duke.edu
Adam DeVore, MD, MHS, FHFSA, FAHA, FACC
- Not yet recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Manuel Castillo, 551-996-2136, manuel.castillo@hmhn.org
Kanika Mody, MD
- Not yet recruiting
Ascension St. Vincent
Indianapolis, Indiana, 46260
Jennifer Brown, 317-338-6439, Jennifer.Brown4@ascension.org
Sunit-Preet Chaudhry, MD, FACC
- Recruiting
Abbott Northwestern
Minneapolis, Minnesota, 555407
Juilanne Feola, 612-863-6066, julianne.feola@allina.com
Kasia Hryniewicz, MD
- Not yet recruiting
Centennial Medical Center
Nashville, Tennessee, 32703
Kristen Kuhn, 615.982.0640, kristen.kuhn2@hcahealthcare.com
Thomas McRae, MD, FACC
- Not yet recruiting
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Manisha Bajpai, MD, 732-258-3649, bajpaima@rwjms.rutgers.edu
Maya Guglin, MD, PhD
- Not yet recruiting
New York Presbyterian - Columbia
New York, New York, 10032
Jessica Idumonyi, (212) 305-1429, joi2102@cumc.columbia.edu
Adil Yunis, MD
- Not yet recruiting
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Alyson Brown, 215-662-2128, alyson.brown@pennmedicine.upenn.edu
Joyce Wald, DO, FACC
- Not yet recruiting
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Laurie Machen, 412-359-6181, Laurie.Machen@ahn.org
Matthew Lander, MD
- Not yet recruiting
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213
Traci Mc Gaha, 412-692-2769, mcgahatl4@upmc.edu
Sideris Facaros, MD
- Not yet recruiting
University of Utah
Salt Lake City, Utah, 84132
Ashley Elmer, 801.585.6775, ashley.elmer@hsc.utah.edu
Stavros Drakos, MD
- Not yet recruiting
Barnes Jewish
St Louis, Missouri, 63110
Jean Flanagan, 314-454-7451, jflanaga@wustl.edu
Justin Vader, MD, MPHS
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
Courtney Nicholas, BS RN, CCRP, CVRN-BC, 813-844-4914, courtneynicholas@tgh.org
Debbie Rinde-Hoffman, MD, FACC, FACP, FHFSA
- Not yet recruiting
Westchester Medical Center
Valhalla, New York, 10595
Rajkumari Bhardwa, 914-493-5599, Rajkumari.Bhardwaj@wmchealth.org
Alan Gass, MD
- Not yet recruiting
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Karen Blinson Research Coordinator, 336-716-5706, karen.blinson@advocatehealth.org
Olivia Gilbert, MD
About this study
Official title: Initiation and Titration of Guideline Directed Medical Therapy in Heart Failure Cardiogenic Shock With Impella 5.5 for Cardiac Recovery: INTeGRATE
The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.
Read the detailed description
This is a prospective, single arm, multi-center, post-market, on-label study. For patients presenting with cardiogenic shock in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis (also known as decompensated heart failure complicated with cardiogenic shock, commonly referred to as heart failure-related cardiogenic shock, HF-CS, including both acute-on-chronic and de novo presentations) as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP), an intentional device-supported strategy with Impella 5.5™ for optimization of guideline-directed medical therapy (GDMT) combined with best practices improves outcomes over standard of care.
- Being tested
- Impella 5.5 SmartAssist
- Keywords
- Impella 5.5, Heart Failure Cardiogenic Shock, Reduced Ejection Fraction Heart Failure, Mechanical Circulatory Support, Cardiovascular Disease, Heart Disease, Guideline Directed Medical Therapy
- Medical subject headings
- Heart Failure, Shock, Cardiogenic, Heart Failure, Systolic, Cardiovascular Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impella 5.5 SmartAssistDevice
The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Other | This is a single arm study. Receives: Device: Impella 5.5 SmartAssist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)
Measured: Timeframe: 180-days post-enrollment
Secondary outcomes (20)
Composite of all-cause death and heart replacement
Measured: 90-days, 180-days, 1-year post-enrollment
Composite of all-cause death, HF hospitalization, and heart replacement
Measured: 90-days, 1-year post-enrollment
All-cause mortality
Measured: Hospital Discharge (within 24 hours) , 90-days, 180-days, 1-year post-enrollment
Cardiovascular mortality
Measured: Hospital Discharge (within 24 hours), 90-days, 180-days, 1-year post-enrollment
Worsening heart failure
HF hospitalization or urgent HF visit
Measured: 90-days, 180-days, 1-year post-enrollment
Composite of all-cause death and worsening heart failure
Measured: 90-days, 180-days, 1-year post-enrollment
Non-HF cardiovascular hospitalization
Measured: 90-days, 180-days, 1-year post-enrollment
All cardiovascular hospitalization
Measured: 90-days, 180-days, 1-year post-enrollment
Composite of all-cause death and all cardiovascular hospitalization
Measured: 90-days, 180-days, 1-year post-enrollment
Rate of major device-related adverse events
The composite rate of any of the following device-related serious adverse events:
- Major vascular access site complication
- Major hemolysis
- Bleeding, defined as MCS-ARC Type 3 or higher
- Structural complication requiring repair
- Stroke
Measured: Hospital Discharge (within 24 hours), 30-days post-enrollment
Subjects achieving indicated GDMT treatment
Achieving any dose of all four classes
Measured: Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
% of Subjects achieving optimized GDMT treatment
Achieving at least 50% of the target dose of all four classes
Measured: 90-days and 180-days post-enrollment
Modified Heart Failure Collaboratory (mHFC) score
Defined by HFC in 2022. Improvement from baseline
Measured: Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment
Rate of GDMT-Related Serious Adverse Events
The composite rate of any of the following GDMT-related serious adverse events:
- Recurrence or worsening shock; symptomatic hypotension requiring admission
- Bradycardia requiring treatment
- Hyperkalemia requiring intervention
- Ketoacidosis requiring treatment
- Need for new renal replacement therapy (RRT)
Measured: Hospital Discharge (within 24 hours), 90-days, and 180-days post-enrollment
Quality of life assessed by EQ-5D
improvement from baseline
Measured: 180-days and 1-year post-discharge
6-Minute Walk Test Distance
improvement from baseline
Measured: 180-days and 1-year post-discharge
Change in LVEF from baseline
Measured: 180-days post-discharge
Change in LVEDD from baseline
Measured: 180-days post-discharge
Change in NYHA HF Class from baseline
Measured: 180-days post-discharge
Change in HF biomarker
NT-proBNP from baseline
Measured: Hospital Discharge (within 24 hours), 30-days, and 90-days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start2 Oct 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Adam DeVore, MD, MHS, Principal investigator, Duke UniversityGavin Hickey, MD, Principal investigator, University of PittsburghManreet Kanwar, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965504
- Sponsor's protocol ID
- INTeGRATE
- Acronym
- INTeGRATE
- Status last verified
- Oct 2026
- First submitted
- 21 Apr 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No