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NAN-101 in Patients With Class III HeartFailure (NAN-CS101)
This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to
explore the safety, feasibility, and efficacy of a single intracoronary infusion of
BNP116.sc-CMV.I1c in patients with NYHA Class III heart failure. Patients with symptomatic
congestive heart failure will be enrolled until up to 12 subjects have received infusions of
investigational product. All patients will be followed until 12 months post treatment
intervention, and then undergo long-term follow-up via semi-structured telephone
questionnaires every 6 months for an additional 24 months (+/- 30 days).
David Murray, MD
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04179643
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Inclusion criteria:
• Age >18 years of age
• Chronic non-ischemic cardiomyopathy
• LVEF 15% ≤ 30% by transthoracic echocardiography (TTE) within 6 months prior to
enrollment
• NYHA Class III HF for a minimum of 3 months HF despite appropriate medical therapy
(defined below):
• Treatment with appropriate HF therapy as tolerated, 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 medications must be stable for ≥ 30 days
prior to enrollment; and
• Cardiac resynchronization therapy (CRT), if clinically indicated, must have been
implanted ≥ 90 days prior to enrollment. Internal cardioverter defibrillator
(ICD) must be implanted, if clinically indicated ≥ 30 days prior to enrollment
• Females of childbearing potential must use at least one of the following acceptable
birth control methods throughout the study and for 6 months after IP administration:
• Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6
months minimum prior to IP administration
• Intrauterine device in place for at least 90 days prior to receiving IP
• Barrier methods (diaphragm plus spermicide or condom) starting at least 30 days prior
to receiving IP
• Abstinence (the subject must be willing to remain abstinent from screening to 6 months
after receiving IP). Females are allowed to claim abstinence as their method of
contraception only when it is the preferred and usual lifestyle of the subject
• Surgical sterilization of the partner(s) (vasectomy) for >180 days prior to IP
administration
• Hormonal contraceptives starting > 90 days prior to IP. If hormonal contraceptives are
started less than 90 days prior to receiving IP, subjects must agree to use a barrier
method (diaphragm plus spermicide or condom) from screening through 90 days after
initiation of hormonal contraceptives
• Males subjects capable of fathering a child:
• Must agree to use a condom from IP administration through 6 months after the time of
IP administration
• Must agree not to donate sperm for 6 months after time of receiving IP
• Documented evidence of vasectomy in males for 180 days minimum prior to receiving IP
is an acceptable form of contraception
• Males who claim abstinence as their method of contraception are allowed provided they
agree to use barrier methods should they become sexually active from screening through
6 months after receiving IP. Males are allowed to claim abstinence as their method of
contraception only when it is the preferred and usual lifestyle of the subject
• Ability to sign Informed Consent Form (ICF) and Release of Medical Information Form
• Appropriate candidate for protocol-specified intracoronary infusion in the judgment of
the infusing interventional cardiologist
Cohort 3: medical history documentation of PLN-R14Del mutation and an ICD in situ (at least
30 days prior to enrollment)
Exclusion Criteria:
• Chronic ischemic cardiomyopathy
• Intravenous (IV) inotropic therapy, intra-aortic balloon pump (IABP) or percutaneous
cardiac assist device therapy within 30 days prior to enrollment
• Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease,
amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic
LV aneurysm
• Cardiac surgery or percutaneous coronary intervention (PCI) within 30 days prior to
enrollment
• Third degree heart block
• Clinically significant myocardial infarction (MI) in the judgment of the subject's
physician (e.g., ST elevation MI [STEMI] or large non-STEMI) within 6 months prior to
enrollment
• Prior heart transplantation, left ventricular reduction surgery (LVRS),
cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device),
surgically implanted LVAD or cardiac shunt
• Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LV reduction
surgery, heart transplant, conventional revascularization procedure, or valvular
repair within 3 months of IP dosing
• Known hypersensitivity to contrast dyes used for angiography; history of, or likely
need for, high-dose steroid pretreatment prior to contrast angiography
• Expected survival < 1 year in the judgment of the investigator
• Active or suspected infection within 48 hours prior to enrollment as evidenced by
fever or positive culture
• Known intrinsic liver disease (e.g., cirrhosis, hepatitis A, chronic hepatitis B or
hepatitis C virus infection). If serology is positive and PCR is negative, subject may
be eligible (confirm with medical monitor).
• Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase
[AST], alkaline phosphatase) > 2x upper limit of normal (ULN) within 30 days prior to
enrollment.
• Renal Failure, dialysis dependent or serum creatinine > 2.5 mg/dl within 30 days prior
to enrollment
• Bleeding diathesis or thrombocytopenia defined as platelets <50,000 platelets/μL
within 30 days prior to enrollment
• Anemia defined as hemoglobin <10 g/dL or transfusion dependent within 30 days prior to
enrollment
• Neutropenia defined as absolute neutrophils <1500 mm3 within 30 days prior to
enrollment
• Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an
absolute neutrophil count <1000 cells/mm3
• Previous participation in a study of gene transfer
• Receiving investigational intervention or participating in another clinical study
within 30 days or within 5 half-lives of another investigational drug administration
prior to administration of NAN-101 that may impact the therapeutic potential of
NAN-101.
• Pregnancy or breastfeeding at the time of screening
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)
The study investigators are interested in learning more about how drugs, that are given to
children by their health care provider, act in the bodies of children and young adults in
hopes to find the most safe and effective dose for children. The primary objective of this
study is to evaluate the PK of understudied drugs currently being administered to children
per SOC as prescribed by their treating provider.
Maria Stanley
All
0 Years to 20 Years old
NA
This study is also accepting healthy volunteers
NCT04278404
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Inclusion Criteria:
1. Participant is < 21 years of age
2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is
willing to provide informed consent/HIPAA:
3. (a) Participant is receiving one or more of the study drugs of interest at the time of
enrollment or (b) Participant is NOT receiving one or more of the study drugs of
interest but is SARS-COV-2 positive within 60 days prior to enrollment
Exclusion Criteria:
1. Participant has a known pregnancy
Below exclusion criteria apply only to:
Participants receiving one or more of the study drugs of interest at the time of
enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for
details on enrollment cohort specifications and additional eligibility criteria)
2. Has had intermittent dialysis within previous 24 hours
3. Has had a kidney transplant within previous 30 days
4. Has had a liver transplant within previous 1 year
5. Has had a stem cell transplant within previous 1 year
6. Has had therapeutic hypothermia within previous 24 hours
7. Has had plasmapheresis within the previous 24 hours
8. Has a Ventricular Assist Device
9. Has any condition which would make the participant, in the opinion of the
investigator, unsuitable for the study
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension, UrinaryTract Infections in Children, Hypertension, Pain, Hyperphosphatemia, Primary Hyperaldosteronism, Edema, Hypokalemia, HeartFailure, Hemophilia, Menorrhagia, Insomnia, Pneumonia, Skin Infection, Arrythmia, Asthma in Children, Bronchopulmonary Dysplasia, Adrenal Insufficiency, Fibrinolysis, Hemorrhage, Attention Deficit Hyperactivity Disorder, Multisystem Inflammatory Syndrome in Children (MIS-C), Kawasaki Disease, Coagulation Disorder, Down Syndrome, Other
Prospective Multi-Center Randomized Study for Evaluating the EVAHEART®2 Left Ventricular Assist System (COMPETENCE)
This is a prospective, multi-center, unblinded, randomized, controlled, and non-inferiority
study comparing the EVA2 LVAS to the most recent magnetically levitated centrifugal LVAS (HM3
LVAS).
Yu Xia
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT01187368
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Inclusion Criteria:
The following is a list of general inclusion criteria:
• Age ≥ 18 years
• Left Ventricular Ejection Fraction (LVEF) < 30%
• NYHA Class III with dyspnea upon mild physical activity or Class IV heart failure
• Inotrope dependent OR Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
• Patient is able to provide written informed consent
• More detailed inclusion criteria information is noted in the study protocol
Exclusion Criteria:
1. Etiology of heart failure due to or associated with uncorrected thyroid disease,
obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive
cardiomyopathy
2. Technical obstacles which pose an inordinately high surgical risk
3. Existence of ongoing mechanical circulatory support (MCS) other than IABP and Impella
5.0 or 5.5
4. Ongoing Impella (5.0 or 5.5) presenting related clinical sign (i.e. hematuria) and
elevated LDH equal or greater than 600 IU/L.
5. Positive pregnancy test if of childbearing potential
6. Presence of mechanical aortic cardiac valve that will not be either converted to a
bioprosthesis
7. History of any organ transplant
8. Platelet count <100,000/mL
9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial
issues
10. History of confirmed, untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter
within 6 months of enrollment
11. Presence of an active, uncontrolled infection
12. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative
therapy that the investigator will require based upon the patient's health status
13. Presence of remarkable pre-defined end-organ dysfunction.
14. Patient has moderate to severe aortic insufficiency without plans for correction
during pump implant
15. Low albumin •removed from recent exclusion criteria
16. Planned Bi-VAD support prior to enrollment
17. Patient has known hypo- or hyper coagulable state such as disseminated intravascular
coagulation and heparin induced thrombocytopenia (HIT)
18. Participation in any other clinical investigation that is likely to confound study
results or affect the study
19. Any condition other than heart failure that could limit survival to less than 24
months
20. Patients refusing blood transfusion
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