GenePHIT: Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects with Non-Ischemic NYHA Cl

Eligibility

Key Inclusion Criteria:

1. Subject must be age ≥18 years of age, at the time of signing the informed consent
2. Chronic non-ischemic cardiomyopathy
3. 6MWT >50 meters
4. Medically stable, NYHA Class III HF for a minimum of 4 weeks while on appropriate medical therapy (defined below) including, but not limited to:
a. Angiotensin-converting enzyme inhibitor (ACE-I), angiotensin receptor-neprilysin inhibitor (ARNI), angiotensin receptor blocker (ARB), sacubitril/valsartan combination therapy (Entresto), beta blocker therapy, mineralocorticoid receptor antagonist (MRA), sodium-glucose co-transporter 2 inhibitor (SGLT2i) for ≥ 90 days prior to enrollment. Doses of the above medications must be stable for ≥ 30 days prior to enrollment.
b. Cardiac resynchronization therapy (Zareba et al., 2011), if clinically indicated, must have been implanted ≥ 90 days prior to enrollment. ICD must be implanted, if clinically indicated ≥ 30 days prior to enrollment.

Key Exclusion Criteria:
1.Chronic ischemic cardiomyopathy secondary to obstructive coronary artery disease
2. Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic LV aneurysm
3. Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap; Cardiac Support Device), surgically implanted LVAD or cardiac shunt
4. Known intrinsic liver disease (e.g., cirrhosis, hepatitis A, chronic hepatitis B or hepatitis C virus infection). If serology is positive and polymerase chain reaction (PCR) is known to be negative, the subject may be eligible (confirm with medical monitor)
5. Previous participation in a study of gene transfer
6. Malignant neoplasm within 5 years of dosing, with the exception of those with negligible risk of metastasis or death (such as adequately treated carcinoma in situs of the cervix, basal or squamous cell skin cancer, localized prostate cancer or ductal carcinoma in situ)

Interested in joining this trial?