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NAN-101 in Patients With Class III Heart Failure (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, Heart Failure, 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
Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2)
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent
multicenter, randomized controlled trials of carotid revascularization and intensive medical
management versus medical management alone in patients with asymptomatic high-grade carotid
stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no
endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with
embolic protection versus no stenting. Medical management will be uniform for all randomized
treatment groups and will be centrally directed.
Victor Weiss
All
35 Years to 100 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02089217
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General Inclusion Criteria
1. Patients ≥35 years old.
2. Carotid stenosis defined as:
• Stenosis ≥70% by catheter angiography (NASCET Criteria); OR
• by DUS with ≥70% stenosis defined by a peak systolic velocity of at least 230
cm/s plus at least one of the following:
1. an end diastolic velocity ≥100 cm/s, or
2. internal carotid/common carotid artery peak systolic velocity ratio ≥4.0, or
3. CTA with ≥ 70% stenosis, or
4. MRA with ≥ 70% stenosis.
3. No medical history of stroke or TIA ipsilateral to the stenosis within 180 days of
randomization. Life-long asymptomatic patients will be defined as having no medical
history of stroke or transient ischemic attack and negative responses to all of the
symptom items on the Questionnaire for Verifying Stroke-free Status (QVSS).18
4. Patients must have a modified Rankin Scale score of 0 or 1 at the time of informed
consent.
5. Women must not be of childbearing potential or, if of childbearing potential, have a
negative pregnancy test prior to randomization.
6. Patients must agree to comply with all protocol-specified follow-up appointments.
7. Patients must sign a consent form that has been approved by the local governing
Institutional Review Board (IRB)/Medical Ethics Committee (MEC) of the respective
clinical site.
8. Randomization to treatment group will apply to only one carotid artery for patients
with bilateral carotid stenosis. Management of the non-randomized stenosis may be done
in accordance with local PI recommendation. Treatment of the non-study internal
carotid artery must take place at least 30 days prior to randomization, or greater
than 44 days after randomization and 30 days after the study procedure is completed
(whichever is longer).
9. Carotid stenosis must be treatable with CEA, CAS, or either procedure.
General Exclusion Criteria
1. Intolerance or allergic reaction to a study medication without a suitable management
alternative.
2. GI hemorrhage within 1 month prior to enrollment that would preclude antiplatelet
therapy.
3. Prior major ipsilateral stroke in the past with substantial residual disability (mRS ≥
2) that is likely to confound study outcomes.
4. Severe dementia.
5. History of major symptomatic intracranial hemorrhage within 12 months that was not
related to anticoagulation.
6. Prior Intracranial hemorrhage that the investigator believes represents a
contraindication to the perioperative or periprocedural antithrombotic and
antiplatelet treatments necessary to complete endarterectomy or stenting per protocol.
7. Current neurologic illness characterized by fleeting or fixed neurologic deficits that
cannot be distinguished from TIA or stroke.
8. Patient objects to future blood transfusions.
9. Platelet count <100,000/microliter or history of heparin-induced thrombocytopenia.
10. Anticoagulation with Phenprocoumon (Marcumar®), warfarin, or a direct thrombin
inhibitor, or anti-Xa agents.
11. Chronic atrial fibrillation.
12. Any episode of atrial fibrillation within the past 6 months or history of paroxysmal
atrial fibrillation that is deemed to require chronic anticoagulation.
13. Other high-risk cardiac sources of emboli, including left ventricular aneurysm, severe
cardiomyopathy, aortic or mitral mechanical heart valve, severe calcific aortic
stenosis (valve area < 1.0 cm2), endocarditis, moderate to severe mitral stenosis,
left atrial thrombus, or any intracardiac mass, or known unrepaired PFO with prior
paradoxical embolism.
14. Unstable angina defined as rest angina with ECG changes that is not amenable to
revascularization (patients should undergo planned coronary revascularization at least
30 days before randomization).
15. Left Ventricular Ejection fraction <30% or admission for heart failure in prior 6
months.
16. Respiratory insufficiency with life expectancy < 4 years or FEV1 <30% of predicted
value.
17. Known malignancy other than basal cell non-melanoma skin cancer. There are two
exceptions to this rule: patients with prior cancer treatment and no recurrence for >5
years are eligible for enrollment and cancer patients with life expectancy of greater
than 5 years are eligible for enrollment.
18. Any major surgery, major trauma, revascularization procedure, or acute coronary
syndrome within the past 1 month.
19. Either the serum creatinine is ≥ 2.5 mg/dl or the estimated GFR is < 30 cc/min.
20. Major (non-carotid) surgery/procedures planned within 3 months after enrollment.
21. Currently listed or being evaluated for major organ transplantation (i.e. heart, lung,
liver, kidney).
22. Actively participating in another drug or aortic arch or cerebrovascular device trial
for which participation in CREST-2 would be compromised with regard to follow-up
assessment of outcomes or continuation in CREST-2.
23. Inability to understand and cooperate with study procedures or provide informed
consent.
24. Non-atherosclerotic carotid stenosis (dissection, fibromuscular dysplasia, or stenosis
following radiation therapy).
25. Previous ipsilateral CEA or CAS.
26. Ipsilateral internal or common carotid artery occlusion.
27. Intra-carotid floating thrombus.
28. Ipsilateral intracranial aneurysm > 5 mm.
29. Extreme morbid obesity that would compromise patient safety during the procedure or
would compromise patient safety during the periprocedural period.
30. Coronary artery disease with two or more proximal or major diseased coronary arteries
with 70% stenosis that have not, or cannot, be revascularized.
Specific carotid endarterectomy exclusion criteria
Patients who are being considered for revascularization by CEA must not have any of the
following criteria:
1. Serious adverse reaction to anesthesia not able to be overcome by pre-medication.
2. Distal/intracranial stenosis greater than index lesion.
3. Any of the following anatomical: radical neck dissection; surgically inaccessible
lesions (e.g. above cervical spine level 2 (C2)); adverse neck anatomy that limits
surgical exposure (e.g. spinal immobility •inability to flex neck beyond neutral or
kyphotic deformity, or short obese neck); presence of tracheostomy stoma; laryngeal
nerve palsy contralateral to target vessel; or previous extracranial-intracranial or
subclavian bypass procedure ipsilateral to the target vessel.
Specific Carotid Artery Stenting Exclusion Criteria
Patients who are being considered for revascularization by CAS must not have any of the
following criteria:
1. Allergy to intravascular contrast dye not amenable to pre-medication.
2. Type III, aortic arch anatomy.
3. Angulation or tortuosity (≥ 90 degree) of the innominate and common carotid artery
that precludes safe, expeditious sheath placement or that will transmit a severe loop
to the internal carotid after sheath placement.
4. Severe angulation or tortuosity of the internal carotid artery (including calyceal
origin from the carotid bifurcation) that precludes safe deployment of embolic
protection device or stent. Severe tortuosity is defined as 2 or more ≥ 90 degree
angles within 4 cm of the target stenosis.
5. Proximal/ostial CCA, innominate stenosis or distal/intracranial stenosis greater than
index lesion.
Excessive circumferential calcification of the stenotic lesion defined as >3mm
thickness of calcification seen in orthogonal views on fluoroscopy.(Note: Anatomic
considerations such as tortuosity, arch anatomy, and calcification must be evaluated
even more carefully in elderly subjects (≥ 70 years).)
6. Target ICA vessel reference diameter <4.0 mm or >9.0 mm. Target ICA measurements may
be made from angiography of the contralateral artery. The reference diameter must be
appropriate for the devices to be used.
7. Inability to deploy or utilize an FDA-approved Embolic Protection Device (EPD).
8. Non-contiguous lesions and long lesions (>3 cm).
9. Qualitative characteristics of stenosis and stenosis-length of the carotid bifurcation
(common carotid) and/or ipsilateral external carotid artery, that preclude safe sheath
placement.
10. Occlusive or critical ilio-femoral disease including severe tortuosity or stenosis
that necessitates additional endovascular procedures to facilitate access to the
aortic arch or that prevents safe and expeditious femoral access to the aortic arch.
"String sign" of the ipsilateral common or internal carotid artery.
11. Angiographic, CT, MR or ultrasound evidence of severe atherosclerosis of the aortic
arch or origin of the innominate or common carotid arteries that would preclude safe
passage of the sheath and other endovascular devices to the target artery as needed
for carotid stenting.
Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension (UNISUS)
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in
prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or
mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH)
compared to macitentan 10 mg.
James Runo, MD
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04273945
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Inclusion Criteria:
• Target population: greater than or equal to (>=) 18 (or the legal age of consent in
the jurisdiction in which the study is taking place) years of age
• Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health
Organization Functional Class (WHO FC) II, III, or IV
• Target population: PAH subtype falling in one of the below classifications:
Idiopathic; Heritable; Drug- or toxin-induced; Related to: Connective tissue disease,
HIV infection, Portal hypertension, and Congenital heart disease with
small/coincidental cardiac defect with systemic-to-pulmonary shunt (for example atrial
septal defect, ventricular septal defect, patent ductus arteriosus, atrioventricular
septal defect) which does not account for the elevated pulmonary vascular resistance
(PVR) or persistent PAH documented by an Right heart catheterization (RHC) >= 1 year
after simple systemic-to pulmonary shunt repair
• PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to
screening: Mean pulmonary artery pressure (mPAP) greater than (>) 20 millimeters of
mercury (mm Hg), and; Pulmonary artery wedge pressure (PAWP) or left ventricular end
diastolic pressure (LVEDP) less than or equal to (<=) 15 mm Hg, and PVR >= 3 Wood
Units (that is, >= 240 dyn*sec/cm^5)
• Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters
(m) and maximum distance of 440m at screening. Participants able to walk more than
440m at screening are eligible if they are in WHO FC III or IV and n-terminal
prohormone of brain natriuretic peptide or n-terminal pro B-type natriuretic peptide
(NT-proBNP) level is >=300 nanograms per liter (ng/L) at screening, based on central
laboratory results
Exclusion Criteria:
• Known presence of three or more of the following risk factors for heart failure with
preserved ejection fraction at screening, based on records that confirm documented
medical history: Body mass index (BMI) > 30 kilograms per meter square (kg/m^2),
Diabetes mellitus of any type, Essential hypertension (even if well controlled);
Coronary artery disease, that is, any of the following: history of stable angina, or
known more than 50 percent (%) stenosis in a coronary artery, or history of myocardial
infarction, or history of or planned coronary artery bypass grafting and/or coronary
artery stenting
• Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1
second [FEV1] / forced vital capacity [FVC] < 70%; and FEV1 < 60% of predicted after
bronchodilator administration) ) in participants with a known or suspected history of
significant lung disease as documented by a spirometry test performed within 1 year
prior to screening
• Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based
on records that confirm documented medical history
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >
1.5*upper limit of normal (ULN) at screening
• Hemoglobin < 100 gram per liter (g/L) (< 10 gram per deciliter [g/dL]) at screening
Pulmonary Arterial Hypertension, Otherpulmonary heart diseases, 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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