Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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 ≤ 30% by transthoracic echocardiography (TTE) within 6 months prior to enrollment
• NYHA Class III HF for a minimum of 6 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
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,
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, Urinary Tract 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
PROACTIVE-HF IDE Trial HeartFailure NYHA Class III (PROACTIVE-HF)
This is a prospective, open- label, single arm, multicenter clinical trial to evaluate the
safety and effectiveness of the Cordella PA Sensor System in NYHA Class III Heart Failure
Patients compared to a Performance Goal (PG).
Farhan Raza
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04089059
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Inclusion Criteria
1. Subject has given written informed consent
2. Male or female, at least 18 years of age
3. Diagnosis and treatment of HF (regardless of left ventricular ejection fraction
(LVEF)) for ≥ 3 months and NYHA Class III HF at time of Screening
4. Subjects should be on stable, optimally titrated medical therapy for at least 30 days,
as recommended according to current American Heart Association (AHA)/American College
of Cardiology (ACC) guidelines as standard-of-care for HF therapy in the United
States, or current European Society of Cardiology (ESC) guidelines for HF treatment in
Europe, with any intolerance documented.
5. HF related hospitalization, HF treatment in a hospital day-care setting, or urgent
outpatient clinic HF visit for IV diuretics within 12 month (last hospitalization
should be 30 days before Screening/Enrollment) and/or N-terminal pro B-type
Natriuretic Peptide (NT proBNP) at time of Screening/ Enrollment defined as:
1. Subjects with LVEF ≤ 50%: NT-proBNP ≥ 1500 pg/mL.
2. Subjects with LVEF > 50%: NT-proBNP ≥ 800 pg/mL . Thresholds for NT-proBNP (for
both LVEF ≤ 50% and LVEF > 50%) will be corrected for body mass index (BMI) using
a 4% reduction per BMI unit over 25 kg/m2
6. Subjects should be on diuretic therapy
7. Subjects who are physically able to hold the myCordella™ Patient Reader unit
(approximate weight 1.3lb) against the ventral thoracic surface for up to 2 minutes
per day while in a seated position, as well as dock and undock the myCordella™ Patient
Reader
8. Subjects with sufficient eyesight, hearing, and mental capacity to respond to the
myCordella™ Patient Reader's audio/visual cues and operate the myCordella™ Patient
Reader
9. Subject has sufficient Cellular and/ or Wi- Fi Internet coverage at home
10. Subject agrees to return to the treating Investigator for all scheduled follow up
visits and can return to the hospital for follow up
Exclusion Criteria
1. Intolerance to all neuro-hormonal antagonists (i.e., intolerance to ACE-I, ARB, ARNI,
and beta-blockers) due to hypotension or renal dysfunction
2. ACC/AHA Stage D refractory HF (including having received or currently receiving
pharmacologic circulatory support with inotropes)
3. Subjects with history of recurrent pulmonary embolism ( ≥2 episodes within 5 years
prior to Screening Visit) and/or deep vein thrombosis (< 3 month prior to Screening
Visit)
4. Subjects who have had a major cardiovascular (CV) event (e.g. myocardial infarction,
stroke) within 3 months of the Screening Visit
5. Unrepaired severe valvular disease
6. Subjects with significant congenital heart disease that has not been repaired and
would prevent implantation of the Cordella PA sensor or mechanical/tissue right heart
valve(s)
7. Subjects with known coagulation disorders
8. Subjects with a hypersensitivity or allergy to platelet aggregation inhibitors
including aspirin, clopidogrel, prasugrel, and ticagrelor; or patients unable to take
dual antiplatelet or anticoagulants for one-month post implant
9. Known history of life threatening allergy to contrast dye
10. Subjects whereby RHC is contraindicated
11. Subjects with an active infection at the Sensor Implant Visit
12. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic
renal dialysis
13. Implanted with Cardiac Resynchronization Therapy (CRT)-Pacemaker (CRT-P) or
CRT-Defibrillator (CRT-D) for less than 90 days prior to screening visit
14. Received or are likely to receive an advanced therapy (e.g. mechanical circulatory
support or lung or heart transplant) in the next 12 months
15. Subjects who are pregnant or breastfeeding
16. Subjects who are unwilling or deemed by the Investigator to be unwilling to comply
with the study protocol, or subjects with a history of non-compliance
17. Severe illness, other than heart disease, which would limit survival to <1 year
18. Subjects whose clinical condition, in the opinion of the Investigator, makes them an
unsuitable candidate for the study
19. Subjects enrolled in another investigational trial with an active treatment arm
20. Subject who is in custody by order of an authority or a court of law
HeartFailure NYHA Class III, Other, Heart & Vascular, Aging & Geriatrics
A phase 3 randomized partial blind storage duration ranging study in patients undergoing
complex cardiac surgery that will compare the transfusion of cold stored platelets to
standard room temperature stored platelets. The primary objective is to establish that cold
stored platelets have a non-inferiority (or superiority) to room temperature platelets.
Eric Simon
All
29 Days to 84 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04834414
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Inclusion Criteria:
• Age greater than 28 days and less than 85 years
• Planned complex cardiac surgery with planned use of cardiopulmonary bypass
Exclusion Criteria:
• Expected order for washed or volume reduced platelets
• Patient with known anti-platelet antibodies
• Platelet transfusion refractoriness due to anti-HLA antibodies
• Known or suspected pregnancy
• Previously randomized in this study
• Conscious objection or unwillingness to receive blood products
• Known IgA deficiency
• Known congenital platelet disorder
• Known congenital bleeding disorder
• Planned post-operative extracorporeal membrane oxygenation (ECMO), ventricular assist
device (VAD), and/or continuous renal replacement therapy (CRRT)/ hemodialysis
• Patients intended to receive whole blood either intra-operative or post-operative for
bleeding
• Platelet transfusion (of any type) within 24 hours prior to the date of surgery
• Pre-operative thrombocytopenia, defined as platelet count <75x10(9)/L, based on the
most recent labs completed within 72 hours prior to the date of surgery.
Acute Blood Loss, Complications of heart transplant, Congenital malformation of heart, unspecified, Heartfailure, Other acute ischemic heart diseases, Other, Heart & Vascular
A Prospective Registry Study to Assess Real-world Patient Characteristics, Treatment Patterns, and Longitudinal Outcomes in Patients Receiving Mavacamten and Other Treatments for Symptomatic Obstructive Hypertrophic Cardiomyopathy (Obstructive HCM) (DISCOVER-HCM)
The purpose of this study is to evaluate the safety of mavacamten in patients with
symptomatic obstructive hypertrophic cardiomyopathy (HCM) treated in the real-world setting.
The registry study also provide a real-world understanding of the current obstructive HCM
patient population, treatment patterns, and clinical relevant outcomes for patients with
symptomatic obstructive HCM in the US.
Aurangzeb Baber
All
18 Years and over
IV
This study is NOT accepting healthy volunteers
NCT05489705
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Inclusion Criteria:
1. Willing and able to provide written informed consent form (ICF) and any required
privacy authorization prior to the initiation of study procedures. i. Diagnosis of
obstructive HCM consistent with 2020 American Heart Association/American College of
Cardiology (AHA/ACC) guidelines. ii. Obstructive HCM is defined clinically by the
presence of increased LV wall thickness ≥ 15 mm (or ≥ 13 mm with positive family
history of HCM) in a nondilated ventricular chamber that is not solely explained by
abnormal loading conditions (eg, another cardiac or systemic disease) and peak LVOT
gradient of
≥ 30 mmHg at rest or with provocation.
2. Has documented LVEF of ≥ 55% recorded by echocardiography within the last 6 months.
3. Symptoms consistent with NYHA functional class II-IV.
4. ≥ 18 years of age at the time of informed consent.
5. Receiving BBs, non-dihydropyridine calcium. channel blockers (non-DHP CCBs),
disopyramide, and/or mavacamten (once available) as part of routine clinical care; or
currently receiving no treatment due to intolerance or failure of prior treatment (eg,
BBs, non-DHP CCBs, or disopyramide) for obstructive HCM.
Exclusion Criteria:
1. Known phenocopy disease (eg, Fabry disease, amyloidosis) or LV hypertrophy associated
with hypertension.
2. Documentation of any fixed obstruction of the outflow tract such as aortic valve
stenosis or replacement.
3. Prior treatment of obstructive HCM with invasive septal reduction (surgical myectomy
or percutaneous alcohol septal ablation [ASA]) within 6 months prior to enrollment;
participants with an unsuccessful myectomy or percutaneous ASA performed > 6 months
prior to enrollment may be enrolled.
4. Naïve to treatment for obstructive HCM (ie, never treated with BBs, non-DHP CCBs, or
disopyramide).
5. Receiving an investigational therapeutic agent for obstructive HCM (eg,
myosin-inhibitors other than mavacamten) in an interventional clinical trial at
participant enrollment.
6. Previously or currently enrolled in a long-term safety extension study of mavacamten
(eg, EXPLORER-HCM [ClinicalTrials.gov, NCT03470545], MAVA-LTE [NCT03723655],
PIONEER-OLE [NCT03496168], VALORHCM [NCT04349072], or MAVERICK [NCT03442764])
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