INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery

NCT06965504 | Not Yet Recruiting FDA Device

• 1 other identifier: INTeGRATE
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Heart Failure; Cardiogenic Shock; Reduced Ejection Fraction Heart Failure

Keywords

Impella 5.5; Heart Failure Cardiogenic Shock; Reduced Ejection Fraction Heart Failure; Mechanical Circulatory Support; Cardiovascular Disease; Heart Disease; Guideline Directed Medical Therapy

Outcome Measures

Primary Outcomes (1)

• Composite of all-cause death, HF hospitalization, and heart replacement (heart transplantation or durable LVAD implantation)

  Timeframe: 180-days post-enrollment

Secondary Outcomes (20)

• Composite of all-cause death and heart replacement

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

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

  90-days, 1-year post-enrollment

• All-cause mortality

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

• Cardiovascular mortality

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

• Worsening heart failure

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

Study Arms (1)

Single arm study

OTHER

This is a single arm study.

Device: Impella 5.5 SmartAssist

Interventions

Impella 5.5 SmartAssist DEVICE

The intervention is Impella 5.5 with SmartAssist® support combined with protocolized guideline directed medical therapy (GDMT) and HF-CS best practices.

Single arm study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and \< 80 years
• Subject has signed the Informed Consent Form. If the subject has been enrolled via an LAR, the subject must provide assent, the assent will be documented.
• LVEF ≤ 40%
• Subject is presenting with decompensated heart failure and meets at least one (1) of the following cardiogenic shock criteria:
• Sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure.
• Cardiac index (CI) \< 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia.
• Require support with an intra-aortic balloon pump (IABP)
• Serum lactate \>2 mmol/L
• 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.

You may not qualify if:

• 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
• o or 3o AV block, unless pacemaker is in place
• 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
• Intra-aortic balloon pump (IABP) use \>24 hours from the onset of cardiogenic shock if placed at the enrolling site or \>48 hours if transferred on IABP prior to enrollment
• On mechanical circulatory support other than IABP (i.e. ECMO, Impella CP, etc) or on mechanical ventilation for non-procedural reasons prior to enrollment
• Revascularization or cardiac surgery within 30-days of the index hospitalization date or decision to undergo revascularization or cardiac surgery made prior to enrollment

Sponsors & Collaborators

• Abiomed Inc.: lead
• Johnson & Johnson: collaborator

Study Sites (7)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Abbott Northwestern

Minneapolis, Minnesota, 555407, United States

Location

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Centennial Medical Center

Nashville, Tennessee, 32703, United States

Location

MeSH Terms

Conditions

Heart Failure; Shock, Cardiogenic; Heart Failure, Systolic; Cardiovascular Diseases; Heart Diseases

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Adam DeVore, MD, MHS

  Duke University

  PRINCIPAL INVESTIGATOR

• Gavin Hickey, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Manreet Kanwar, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 11, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)