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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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
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
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 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)
Show all 11Show fewer
  • 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
Show all 45Show fewer
  • 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.

Roberta Chapman, MD, FACC, FACP, FHFSA contact

+1 978-882-8421

rchapm11@its.jnj.com

Stacie Hallaway contact

839-216-3087

shallawa@its.jnj.com

17 sites in 1 country

United States17 sites, 17 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

    Not yet recruiting

  • Abbott Northwestern

    Minneapolis, Minnesota, 555407

    Juilanne Feola, 612-863-6066, julianne.feola@allina.com

    Kasia Hryniewicz, MD

    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

    Not yet 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

    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

    Not yet recruiting

Other trials in United States

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 groups in NCT06965504
Study groupRoleWhat they receive
Single arm studyOtherThis 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.

  1. 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)

  1. Composite of all-cause death and heart replacement

    Measured: 90-days, 180-days, 1-year post-enrollment

  2. Composite of all-cause death, HF hospitalization, and heart replacement

    Measured: 90-days, 1-year post-enrollment

  3. All-cause mortality

    Measured: Hospital Discharge (within 24 hours) , 90-days, 180-days, 1-year post-enrollment

  4. Cardiovascular mortality

    Measured: Hospital Discharge (within 24 hours), 90-days, 180-days, 1-year post-enrollment

  5. Worsening heart failure

    HF hospitalization or urgent HF visit

    Measured: 90-days, 180-days, 1-year post-enrollment

  6. Composite of all-cause death and worsening heart failure

    Measured: 90-days, 180-days, 1-year post-enrollment

  7. Non-HF cardiovascular hospitalization

    Measured: 90-days, 180-days, 1-year post-enrollment

  8. All cardiovascular hospitalization

    Measured: 90-days, 180-days, 1-year post-enrollment

  9. Composite of all-cause death and all cardiovascular hospitalization

    Measured: 90-days, 180-days, 1-year post-enrollment

  10. Rate of major device-related adverse events

    The composite rate of any of the following device-related serious adverse events:

    1. Major vascular access site complication
    2. Major hemolysis
    3. Bleeding, defined as MCS-ARC Type 3 or higher
    4. Structural complication requiring repair
    5. Stroke

    Measured: Hospital Discharge (within 24 hours), 30-days post-enrollment

  11. Subjects achieving indicated GDMT treatment

    Achieving any dose of all four classes

    Measured: Hospital Discharge(within 24 hours), 90-days, 180-days post-enrollment

  12. % 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

  13. 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

  14. Rate of GDMT-Related Serious Adverse Events

    The composite rate of any of the following GDMT-related serious adverse events:

    1. Recurrence or worsening shock; symptomatic hypotension requiring admission
    2. Bradycardia requiring treatment
    3. Hyperkalemia requiring intervention
    4. Ketoacidosis requiring treatment
    5. Need for new renal replacement therapy (RRT)

    Measured: Hospital Discharge (within 24 hours), 90-days, and 180-days post-enrollment

  15. Quality of life assessed by EQ-5D

    improvement from baseline

    Measured: 180-days and 1-year post-discharge

  16. 6-Minute Walk Test Distance

    improvement from baseline

    Measured: 180-days and 1-year post-discharge

  17. Change in LVEF from baseline

    Measured: 180-days post-discharge

  18. Change in LVEDD from baseline

    Measured: 180-days post-discharge

  19. Change in NYHA HF Class from baseline

    Measured: 180-days post-discharge

  20. 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.

  1. First posted11 May 2025
  2. Study start2 Oct 2026
  3. Primary completion1 Dec 2028 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 11 inclusion and 45 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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 Roberta Chapman, MD, FACC, FACP, FHFSA (+1 978-882-8421, rchapm11@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation) (time frame: Timeframe: 180-days post-enrollment). 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 NCT06965504.

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 13 Oct 2026.

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