Heart Failure study: Impella
Official title INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery
ClinicalTrials.gov ID: NCT06965504
What this study is testing
- What it's testing
- The study will see whether using the Impella 5.5 device together with the best drug treatment improves heart recovery in patients with decompensated heart failure and cardiogenic shock.
- Who it's for
- Adults who have heart failure with reduced ejection fraction and are in cardiogenic shock.
- What's involved
- Participants will receive the Impella 5.5 device and a carefully chosen medication plan, and will have regular heart function tests and follow‑up visits.
- Time commitment
- The study lasts until the patient’s heart function improves or the study ends, with multiple hospital visits and monitoring during that time.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥ 18 and \< 80 years
- Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form
- LVEF ≤ 40%
- Hypotension (sustained episode of systolic blood pressure ≤ 90 mmHg for at least 30 minutes or need for inotropic/vasoactive agents to maintain such...
- Hypoperfusion (physical sign(s) of organ hypoperfusion or serum lactate \>2 mmol/L)
You likely can't join if
- Drug allergies or hypersensitivities\ to HF GDMT medications, unless alternative can be identified \ Drug allergy/hypersensitivity is an...
- 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
See the full eligibility criteria
- Age ≥ 18 and \< 80 years
- Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form
- LVEF ≤ 40%
- 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)
- Hypoperfusion (physical sign(s) of organ hypoperfusion or serum lactate \>2 mmol/L)
- Cardiac index (CI) \< 2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
- Required support with an intra-aortic balloon pump (IABP) or Impella CP™
- 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
- Drug allergies or hypersensitivities\ to HF GDMT medications, unless alternative can be identified \ Drug allergy/hypersensitivity is an immune-mediated reaction to a medication.
- 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
- IABP use \>24 hours if placed at the enrolling site or \>48 hours if transferred on IABP
- Impella CP™ use \>24 hours if placed at the enrolling site or \>48 hours if transferred on Impella CP™
- Experienced complication(s) from IABP including clinically significant vascular injury, limb ischemia, end organ damage, or bleeding requiring transfusion(s) per Investigator's discretion
- 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...
- 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
- Mural thrombus in the left ventricle
- Severe arterial disease precluding placement of Impella
- Presence of atrial or ventricular septal defect
- Left ventricular rupture
- Cardiac tamponade
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Tampa, Florida, United States
- Minneapolis, Minnesota, United States
- New Brunswick, New Jersey, United States
- Dallas, Texas, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tampa, Florida, United States; Minneapolis, Minnesota, United States; New Brunswick, New Jersey, United States; Dallas, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.