Congestive Heart Failure (CHF)
NAN-CS101 is an open-label Phase 1, dose-escalation clinical trial evaluating the safety and efficacy of a single infusion of AB-1002, an investigational gene therapy that aims to activate a key protein to stop the action of type 1 protein phosphatase (PP1), a substance that plays an important role in the development of heart failure, in people with Congestive Heart Failure (CHF).
What is Congestive Heart Failure (CHF)?
CHF is a chronic condition that gets worse over time. It can result from the weakening or stiffening of the heart muscle, or from increased oxygen demand by body tissues beyond the heart’s capability. CHF happens when the heart is unable to supply enough blood and oxygen to the body.
Patients with CHF may experience a range of debilitating symptoms, including:
- Shortness of breath
- Weight gain
- Swollen ankles, legs or abdomen
- Rapid heart rate
CHF is a chronic disease that severely impacts quality of life; if you think you have CHF, please talk to a medical professional.
About the NAN-CS101 Trial
NAN-CS101 is an open-label, Phase 1, dose-escalation clinical trial evaluating the safety and potential effect of AB-1002 in patients with NYHA Class III heart failure. AB-1002 is a one-time gene therapy administered to the heart to help promote increased production of a therapeutic protein inhibitor 1 (I-1c) designed to block the action of PP1, which is linked to CHF. Participants will be assigned to one of three dose levels of AB-1002.
Learn more about the this study at clinicaltrials.gov.
AB-1002 is an investigational therapy and has not been approved by the U.S. Food & Drug Administration (FDA) or any other healthcare authority for commercial use.
Clinical trial activities are outlined below:
Used to determine eligibility
Gene Therapy Administration
Administration of one-time infusion of AB-1002 by cardiac catheterization and infusion into the arteries of the heart
Occur approximately weekly to twice a month for the first 3 months following administration, then every three months for the remainder of the first year.
Long Term Follow Up Period
After the first year of participation post-administration, follow-up visits will occur every 6 months for 2 additional years.
Are You Eligible?
All clinical trials have specific eligibility criteria that patients must meet to participate. These are called inclusion and exclusion criteria and are related to a person’s health when they enter the clinical trial.
You may be eligible if:
- Are over 18 years of age
- Have chronic non-ischemic cardiomyopathy
- Have a confirmed diagnosis of New York Heart Association (NYHA) Class III heart failure for a minimum of 6 months despite appropriate medical therapy*
*Including but not limited to: Beta blocker therapy and angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or sacubitril/valsartan combination therapy (Entresto) for ≥90 days prior to enrollment. May also receive aldosterone antagonist therapy. Doses of the above medication must be stable for ≥30 days prior to enrollment. Cardiac resynchronization therapy, if clinically indicated, must have been implanted ≥90 days prior to enrollment. Internal cardioverter defibrillator (ICD) must have been implanted, if clinically indicated ≥30 days prior to enrollment.
You are not eligible if:
- Have chronic ischemic cardiomyopathy
- Have received intravenous (IV) inotropic therapy, intra-aortic balloon pump (IABP) or percutaneous cardiac assist device therapy within 30 days prior to enrollment
- Have restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or dyskinetic left ventricular (LV) aneurysm
- Have had cardiac surgery or percutaneous coronary intervention (PCI) within 30 days prior to screening
- Have third degree heart block
- Have had a clinically significant myocardial infarction (MI) within 6 months prior to enrollment
The NAN-CS101 Study
To find out if you are eligible for this clinical trial, you should talk to your doctor, or to find out more about this study, please visit clinicaltrials.gov.