Status:
NOT_YET_RECRUITING
INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery
Lead Sponsor:
Abiomed Inc.
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Heart Failure
Cardiogenic Shock
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 i...
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 wi...
Eligibility Criteria
Inclusion
- Age ≥18 and \< 75 years
- Subject has signed the Informed Consent
- LVEF ≤ 40%
- History of HF \<5 years
- Subject is presenting with decompensated heart failure and meets one 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.
- Or serum lactate \> 2 mmol/L
- Or a cardiac index (CI) \< 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
- Or required support with an intra-aortic balloon pump (IABP)
- 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:
- On 2 or less of the evidence-based GDMT (BB, MRA, SGLT2i, and RASi)
- If on β-blocker and RASi, at least one of the two medications is \<50% of maximal dose.
Exclusion
- 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
- 2nd or 3rd degree AV block, unless pacemaker is in place
- Angioedema, hereditary or idiopathic
- Pregnancy, known or confirmed by a pregnancy test if of child bearing potential.
- Cardiogenic shock due to myocardial infarction prior to enrollment
- Mixed shock, septic shock, or shock from non-cardiac origins
- Severe Cardiogenic Shock, defined as meeting one or more of the below prior to enrollment:
- SCAI stage E per Study Definition (Appendix C)
- Serum lactate \> 8mmol/L
- On mechanical circulatory support (not including IABP) or on mechanical ventilation for non-procedural reasons.
- Experiencing pulseless electrical activity (PEA) or refractory ventricular tachycardia (VT)/ventricular fibrillation (VF)
- Severe acidosis (pH \< 7.2 or bicarbonate \< 10mEq/L)
- In cardiac arrest prior to enrollment
- Revascularization or cardiac surgery within 90-days of the index hospitalization date or decision to undergo revascularization or cardiac surgery made prior to enrollment.
- Inflammatory and infiltrative cardiomyopathy (CM) including myocarditis, restrictive CM, constrictive pericarditis, or hypertrophic CM including sarcoidosis and amyloidosis.
- Adult congenital heart disease without appropriate surgical correction
- Structural or anatomical abnormalities that cannot be modified as determined by the treating cardiologist, including severe primary mitral regurgitation (MR) .
- Severe RV dysfunction, per Study Definition (Appendix C), requiring mechanical or inotropic support prior to enrollment.
- Severe dilatation of the LV with LVEDD greater than 8.0cm
- History of heart transplant or listed for heart transplant prior to enrollment.
- Planned to be implanted with a permanent VAD within 90-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 2 years due to non-cardiac illness at the time of index hospitalization date.
- ICD upgrade to BiV, or implantation of CRT within 30-days of the index hospitalization date.
- Currently on dialysis, or has pre-existing end-stage chronic kidney disease (stage 4 or above), or has hereditary, infectious, or autoimmune nephropathy.
- Pre-existing liver dysfunction defined as: presence of liver cirrhosis or alcoholic hepatitis, or presence of acute liver failure or acute hepatitis not due to cardiogenic shock.
- Pre-existing pulmonary disease requiring home oxygen
- History of stroke or intracranial hemorrhage ≤ 90 days of the index hospitalization date, or a history of cerebrovascular disease with significant (\> 80%) uncorrected carotid stenosis, or any permanent neurological deficit with mRS score \>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.
- Thrombus in the left atrium or ventricle.
- Infection of the planned procedural access site or suspected systemic active infection.
- Severe arterial disease precluding placement of Impella.
- Presence of Atrial or Ventricular Septal Defect (including post-infarct VSD)
- Left ventricular rupture
- Cardiac tamponade I. Combined cardiorespiratory failure
- Known contraindication to heparin (i.e., heparin induced thrombocytopenia (HIT)) or intolerance to anticoagulant or antiplatelet therapies.
- Allergies or contraindications to contrast agents unless can be adequately medicated.
- History of bleeding diathesis or known coagulopathy, any GU or GI bleed within 90-days of the index hospitalization date 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 that has not met its primary endpoint.
- Subject belongs to a vulnerable population, such as such as prisoners, individuals with impaired decision making, or economically or educationally disadvantaged persons.
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Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06965504
Start Date
December 1 2025
End Date
June 1 2028
Last Update
June 15 2025
Active Locations (5)
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1
Tampa General Hospital
Tampa, Florida, United States, 33606
2
Abbott Northwestern
Minneapolis, Minnesota, United States, 555407
3
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
4
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104