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

Starting soon · Not applicable

Conditions studied: Heart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure

In brief

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.

Key facts

Study ID

NCT06965504

Run by

Abiomed Inc.

People needed

250

Starts

2026-04-01

Expected to finish

2029-06-01

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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
• 2o 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
• Infiltrative/restrictive cardiomyopathy (sarcoidosis and amyloidosis), hypertrophic cardiomyopathy, constrictive pericarditis, pericardiac tamponade, or fulminant myocarditis (giant cell or immune checkpoint inhibitor)
• 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 liver disease including liver cirrhosis, alcoholic hepatitis, metabolic dysfunction associated steatohepatitis (MASH), or genetic liver disease.

Where it is running

• 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
• Atrium Health — Charlotte, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Centennial Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.