Loading clinical trials...

INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

Initiation and Titration of Guideline Directed Medical Therapy in Heart Failure Cardiogenic Shock With Impella 5.5 for Cardiac Recovery: INTeGRATE

NCT06965504•Abiomed Inc.

View on ClinicalTrials.gov

Summary

The study will evaluate if Impella 5.5® support in heart failure reduced ejection fraction (HFrEF) patients presenting with decompensated heart failure (HF) and cardiogenic shock will facilitate the initiation and optimization of guideline directed medical therapy (GDMT) during the hospital stay and post-discharge.

Detailed Description

This is a prospective, single arm, multi-center, post-market, on-label study. Patients presenting with HFrEF who are not on adequate GDMT and who are presenting with heart failure cardiogenic shock will be evaluated for inclusion. The study objectives are to evaluate the impact of Impella 5.5 support on GDMT up-titration during support, at discharge, and at 90-days post-discharge and to evaluate the feasibility of Impella 5.5 combined with optimal GDMT to improve heart recovery in patients with decompensated heart failure. Outcomes will be measured up to one-year post-hospital discharge.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 and \< 75 years
•2. Subject has signed the Informed Consent
•3. LVEF ≤ 40%
•4. History of HF \<5 years
•5. Subject is presenting with decompensated heart failure and meets one of the following cardiogenic shock criteria:
•1. Sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure.
•2. Or serum lactate \> 2 mmol/L
•3. Or a cardiac index (CI) \< 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
•4. Or required support with an intra-aortic balloon pump (IABP)
•6. Subject has inadequate heart failure GDMT based on the most recent outpatient prescription prior to index admission as determined by the treating cardiologist and the Eligibility Committee, defined as:
+2 more criteria

Exclusion Criteria

•1. Underlying unmodifiable conditions that limit initiation of GDMT prior to enrollment, including but not limited to:
•1. 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:
•2. Known bilateral renal artery stenosis
•3. Type 1 diabetes
•4. 2nd or 3rd degree AV block, unless pacemaker is in place
•5. Angioedema, hereditary or idiopathic
•6. Pregnancy, known or confirmed by a pregnancy test if of child bearing potential.
•2. Cardiogenic shock due to myocardial infarction prior to enrollment
•3. Mixed shock, septic shock, or shock from non-cardiac origins
+38 more criteria

Locations (5)

Tampa General Hospital

Tampa, Florida, United States

Abbott Northwestern

Minneapolis, Minnesota, United States

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Centennial Medical Center

Nashville, Tennessee, United States

Key Dates

Start Date

April 1, 2026

Primary Completion Date

December 1, 2028

Completion Date

June 1, 2029

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Heart FailureCardiogenic ShockReduced Ejection Fraction Heart Failure

Interventions

Impella 5.5 SmartAssist

DEVICE

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

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

NCT07484009

Acute Heart Failure (AHF)Heart Failure (for Example, Fluid Overload)+1 more

View study

RECRUITING

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure