RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Impella 5.5 heart pump, used with recommended heart failure medicines, helps the heart recover. It is for adults with worsening heart failure and cardiogenic shock, when the heart cannot pump enough blood to the body.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 to 79.
  • You or your legal representative signs a consent form.
  • Your heart pumps out 40% or less of the blood in its main pumping chamber with each beat.
  • You have worsening heart failure and at least two listed signs of shock: very low blood pressure or drugs needed to support it; poor blood flow to organs; a low measured heart pumping rate not caused by low blood volume; or support from an IABP balloon pump or Impella CP heart pump.
  • Before this hospital stay, you were prescribed no more than two of the four main types of heart failure medicine. If you took both a beta blocker and a renin-angiotensin system medicine, at least one was below half its maximum target dose.

Who can't join

  • You have a condition that prevents use of the study medicines, such as certain drug allergies, narrowed arteries to both kidneys, type 1 diabetes, certain heart signal blocks without a pacemaker, certain swelling disorders, or pregnancy.
  • You have a recent heart attack or sudden loss of blood flow to the heart, shock from infection or other non-heart causes, mixed shock, the study's most severe stage of heart shock, or cardiac arrest before enrollment.
  • You have used an IABP or Impella CP for over 24 hours at the study hospital or over 48 hours if transferred, or had major pump complications. Other heart support machines, a breathing machine outside a procedure, or heart surgery or restored heart blood flow within 30 days also rule you out.
  • You have certain heart muscle, heart lining, birth-related, or severe valve problems; mainly right-sided heart weakness; a past or planned heart transplant; a planned permanent heart pump within 180 days; or continuous home medicine through a vein to help the heart pump.
  • You have dialysis or certain serious kidney, liver, or oxygen-dependent lung diseases; a stroke or brain bleed within 90 days; certain severe neck artery narrowing; or lasting brain or nerve problems that limit daily life. Planned hospice or comfort care, or less than one year to live from a non-heart illness, also rules you out.
  • The Impella 5.5 cannot be placed safely because of certain valve problems, implanted heart devices, a heart clot, severe artery disease, a hole or tear in the heart, fluid pressing on the heart, or combined heart and breathing failure.
  • You have an active body-wide infection or infection where the pump would enter, cannot take blood-thinning medicines, or refuse blood transfusions.
  • You have problems that prevent consent or following study steps, are in treatment or follow-up in another trial of an experimental drug or device, or belong to a vulnerable group listed by the study, such as prisoners or people with certain disabilities or economic or educational disadvantages.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age ≥ 18 and \< 80 years 2. Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form 3. LVEF ≤ 40% 4. 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™ 5. 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: 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. 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 2. ST-segment elevation or acute coronary syndrome (ACS) prior to enrollment 3. Septic shock, shock from non-cardiac origins, or mixed shock 4. SCAI Stage E cardiogenic shock per study definition (Appendix C) prior to enrollment 5. In cardiac arrest prior to enrollment 6. 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 7. 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 8. Revascularization or cardiac surgery within 30-days prior to enrollment 9. Infiltrative/restrictive cardiomyopathy (sarcoidosis and amyloidosis), hypertrophic cardiomyopathy, constrictive pericarditis, pericardiac tamponade, or myocarditis requiring high-dose immunosuppression 10. Complex adult congenital heart disease 11. Primary severe valvular disease 12. Predominant RV dysfunction per Investigator's discretion 13. History of heart transplant or listed for heart transplant or planned for heart transplantation prior to enrollment 14. Planned to be implanted with a permanent VAD within 180-days of the index hospitalization date 15. Continuous outpatient inotropic support prior to the index hospitalization date 16. 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 17. 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 18. Pre-existing functional liver disease including liver cirrhosis, alcoholic hepatitis, metabolic dysfunction associated steatohepatitis (MASH), or genetic liver disease 19. Pre-existing pulmonary disease with oxygen dependency 20. 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 21. 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 22. Infection of the planned procedural access site or systemic active infection including sepsis and bacteremia 23. Intolerance to anticoagulant or antiplatelet therapies, or will refuse blood transfusions 24. 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 25. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device 26. 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)

Study sites (17)

FL

IN

MN

MO

NC

NJ

NY

PA

TN

TX

UT