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

Abiomed

Status

Not yet enrolling

Conditions

Heart Failure

Cardiogenic Shock

Reduced Ejection Fraction Heart Failure

Treatments

Device: Impella 5.5 SmartAssist

Study type

Interventional

Funder types

Industry

Identifiers

NCT06965504

INTeGRATE

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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:
1. 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)
2. Hypoperfusion (physical sign(s) of organ hypoperfusion or serum lactate >2 mmol/L)
3. Cardiac index (CI) < 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
4. 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:
1. On 2 or less of the 4-Pillar HF Drug Classes (BB, MRA, SGLT2i, and RASi)
2. If on BB and RASi, at least one of the two medications is < 50% of the maximal target dose

Exclusion criteria

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. 2o or 3o AV block, unless pacemaker is in place
5. Angioedema, hereditary or idiopathic
6. 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:
1. IABP use >24 hours if placed at the enrolling site or >48 hours if transferred on IABP
2. Impella CP™ use >24 hours if placed at the enrolling site or >48 hours if transferred on Impella CP™
3. Experienced complication(s) from IABP including clinically significant vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion
4. 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:
1. Aortic valve stenosis/calcification with orifice area ≤ 0.6cm2 or aortic insufficiency of any grade greater than mild on pre-procedure echocardiography
2. Presence of mechanical aortic valve or heart constrictive device
3. Mural thrombus in the left ventricle
4. Severe arterial disease precluding placement of Impella
5. Presence of atrial or ventricular septal defect
6. Left ventricular rupture
7. Cardiac tamponade
8. 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)