Is NCT06965504 recruiting in New Brunswick, NJ?

Yes, NCT06965504 is currently recruiting participants at its New Brunswick, NJ location. This heart failure clinical trial is actively enrolling qualified participants.

How do I join the heart failure clinical trial in New Brunswick?

To join this clinical trial in New Brunswick, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New Brunswick clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Heart Failure Clinical Trial in New Brunswick, NJ

Who Can Participate

Inclusion Criteria

Age ≥ 18 and \< 80 years

Subject or subject's legally authorized representative (LAR) has signed the Informed Consent Form

Subject is presenting with decompensated heart failure and meets at least two (2) of the following cardiogenic shock criteria:

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™

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

Exclusion Criteria

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

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:

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 neurological deficit with modified Rankin Scale (mRS) \>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

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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Brunswick?

Yes, this clinical trial (NCT06965504) has an active research site in New Brunswick, NJ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Heart Failure Treatment Options in New Brunswick, NJ

If you're searching for heart failure treatment options in New Brunswick, NJ, this clinical trial (NCT06965504) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Brunswick research site is actively enrolling participants for this clinical trial. You'll receive care from experienced heart failure specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all heart failure clinical trials near you to find additional studies recruiting in your area.

Heart Failure Clinical Trial in New Brunswick, NJ

Expert Care in New Brunswick

IRB Approved

No-Cost Care

Apply for This New Brunswick Location

Why Participate?

Simple Process

About This Heart Failure Study in New Brunswick