Clinical trial: Anxiety-mediated Impairments in Large Elastic Artery Function and the Autonomic Nervous System (NCT03109795)

Eligibility criteria:
Inclusion Criteria for participants with moderate-to-high anxiety to undergo drug
        intervention:

          -  Willing and able to provide written, signed consent after the nature of the study has
             been explained, and prior to any research-related procedures.

        Age is > or = 18 and < or = 79 years

        No history of cardiovascular disease (e.g., heart attack, stroke, heart failure, valvular
        heart disease, cardiomyopathy), or peripheral arterial disease.

        Non-smokers, defined as no history of smoking or no smoking for at least the past 3 months.

        Normal resting 12-lead ECG (no evidence of myocardial infarction, left ventricular
        hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
        fibrillation/flutter, atherosclerosis).

        Blood chemistries indicative of normal renal (creatinine <2.0mg/dl), liver (<3 times upper
        limit for ALT, AST), and thyroid function (TSH between 0.4 - 5.0 mU/L) or on stable thyroid
        medication with no dose change for 3 months.

        Exclusion Criteria:

          -  Current use of clonidine or beta-blockers

        Current use of antihypertensive medications for reasons other than hypertension (e.g.,
        hydrochlorothiazide for leg edema or kidney stone prevention, beta-blockers for tremor)

        Difficult to control hypertension (e.g., on 2 or 3 antihypertensive medications)

        Low blood pressure (e.g., systolic BP < 110 mmHg)

        Hypertensive and have not been stable on their current antihypertensive medication regimen
        for at least 6 months

        Blood pressure not controlled either on or off antihypertensive medications (e.g., BP >
        150/100)

        Current diagnosis or history of cancer, liver disease, HIV/AIDS

        History of brain tumor, aneurysm or injury

        Clinical diagnosis of mental health disorders such as bipolar disorder or schizophrenia

        History of cardiovascular disease such as heart angioplasty/stent or bypass surgery,
        myocardial infarction, stroke, heart failure with or without LV ejection fraction <40%,
        cardiomyopathy, valvular heart disease, cardiomyopathy, heart transplantation,
        atherosclerosis.

        Current tobacco user or history of tobacco use within the past 3 months (cigarettes,
        cigars, chewing tobacco, Hookah).

        History of lung emphysema, chronic bronchitis or chronic obstructive pulmonary disease
        (COPD).

        Abnormal resting 12-lead ECG (e.g., evidence of myocardial infarction, left ventricular
        hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
        fibrillation/flutter, atherosclerosis).

        Serious neurologic disorders including seizures.

        History of renal failure, dialysis or kidney transplant.

        Use of any investigational products or investigational medical devices within 30 days prior
        to screening, or requirement for any investigational agent prior to completion of all
        scheduled study assessments.

        Recent flu-like symptoms within the past 2 weeks.

        Pregnant or breastfeeding at screening, or planning to become pregnant (self or partner) at
        any time during the study. A urinary pregnancy test will be done on all females. If test is
        positive, the subject will be excluded.

        History of rheumatoid arthritis, Grave's disease, systemic lupus erythamatosis, and
        Wegener's granulomatosis.

        Taking anticoagulation, anti-seizure, or antipsychotic agents.

        Start of or dose change to an antidepressant or anti-anxiety medication within the past 3
        months (if no change in medication or dose in past 3 month, then subject will be eligible).

        Immunodeficiency or systemic autoimmune disease.

        History of bleeding disorders or conditions of the microcirculation (i.e. von Willebrand
        disease, Raynaud's disease).

        History of co-morbid condition that would limit life expectancy to <1 year.

        Taking chronic non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin,
        indomethacin, naproxen, acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®) and not able
        or willing to go off of for 2 weeks prior to each study visit.

        Taking cox-2 inhibitors (Celebrex®, Vioxx®, etc) or allopurinol (Zyloprim®, Lopurin®,
        Aloprim®).

        Taking steroids or biologics: corticosteroids (prednisone); methotrexate, infliximib
        (Remicade®), etaneracept (Enbrel®); anakinra (Kineret®).

        Those who are currently donating blood, platelets, or plasma at the time of screening.

        Vulnerable populations (prisoners, etc.) will not be eligible to participate in this study.

        On weight loss drugs (i.e. orilistat (Xenical®), sibutramine (Meridia®),
        phenylpropanol-amine (Acutrim®)), or similar over-the-counter medications within 3 months
        of screening.

        Any surgery within 30 days of screening

        Those who currently donate blood, platelets, or plasma

        Any condition that, in the view of the PI or Co-I, places the subject at high risk or poor
        treatment and study compliance.

        We will also enroll 36 participants ages 18-79 years (50% men, 50% women) with low or no
        anxiety as control subjects to participate in only baseline testing (not participate in the
        drug intervention).

        Inclusion criteria:

        Willing and able to provide written, signed consent after the nature of the study has been
        explained, and prior to any research-related procedures.

        Age is > or = 18 and < or = 79 years

        No history of cardiovascular disease (e.g., heart attack, stroke, heart failure, valvular
        heart disease, cardiomyopathy), or peripheral arterial disease.

        Non-smokers, defined as no history of smoking or no smoking for at least the past 3 months.

        Normal resting 12-lead ECG (no evidence of myocardial infarction, left ventricular
        hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
        fibrillation/flutter, atherosclerosis).

        Blood chemistries indicative of normal renal (creatinine <2.0mg/dl), liver (<3 times upper
        limit for ALT, AST), and thyroid function (TSH between 0.4 - 5.0 mU/L) or on stable thyroid
        medication with no dose change for 3 months.

        Exclusion Criteria:

        Current use of clonidine or beta-blockers

        Current use of antihypertensive medications for reasons other than hypertension (e.g.,
        hydrochlorothiazide for leg edema or kidney stone prevention, beta-blockers for tremor)

        Difficult to control hypertension (e.g., on 2 or 3 antihypertensive medications)

        Low blood pressure (e.g., systolic BP < 110 mmHg)

        Hypertensive and have not been stable on their current antihypertensive medication regimen
        for at least 6 months

        Blood pressure not controlled either on or off antihypertensive medications (e.g., BP >
        150/100)

        Current diagnosis or history of cancer, liver disease, HIV/AIDS

        History of brain tumor, aneurysm or injury

        Clinical diagnosis of mental health disorders such as bipolar disorder or schizophrenia

        History of cardiovascular disease such as heart angioplasty/stent or bypass surgery,
        myocardial infarction, stroke, heart failure with or without LV ejection fraction <40%,
        cardiomyopathy, valvular heart disease, cardiomyopathy, heart transplantation,
        atherosclerosis.

        Current tobacco user or history of tobacco use within the past 3 months (cigarettes,
        cigars, chewing tobacco, Hookah).

        History of lung emphysema, chronic bronchitis or chronic obstructive pulmonary disease
        (COPD).

        Abnormal resting 12-lead ECG (e.g., evidence of myocardial infarction, left ventricular
        hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
        fibrillation/flutter, atherosclerosis).

        Serious neurologic disorders including seizures.

        History of renal failure, dialysis or kidney transplant.

        Use of any investigational products or investigational medical devices within 30 days prior
        to screening, or requirement for any investigational agent prior to completion of all
        scheduled study assessments.

        Recent flu-like symptoms within the past 2 weeks.

        Pregnant or breastfeeding at screening, or planning to become pregnant (self or partner) at
        any time during the study. A urinary pregnancy test will be done on all females. If test is
        positive, the subject will be excluded.

        History of rheumatoid arthritis, Grave's disease, systemic lupus erythamatosis, and
        Wegener's granulomatosis.

        Taking anticoagulation, anti-seizure, or antipsychotic agents.

        Start of or dose change to an antidepressant or anti-anxiety medication within the past 3
        months (if no change in medication or dose in past 3 month, then subject will be eligible).

        Immunodeficiency or systemic autoimmune disease.

        History of bleeding disorders or conditions of the microcirculation (i.e. von Willebrand
        disease, Raynaud's disease).

        History of co-morbid condition that would limit life expectancy to <1 year.

        Taking chronic non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin,
        indomethacin, naproxen, acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®) and not able
        or willing to go off of for 2 weeks prior to each study visit.

        Taking cox-2 inhibitors (Celebrex®, Vioxx®, etc) or allopurinol (Zyloprim®, Lopurin®,
        Aloprim®).

        Taking steroids or biologics: corticosteroids (prednisone); methotrexate, infliximib
        (Remicade®), etaneracept (Enbrel®); anakinra (Kineret®).

        Those who are currently donating blood, platelets, or plasma at the time of screening.

        Vulnerable populations (prisoners, etc.) will not be eligible to participate in this study.

        On weight loss drugs (i.e. orilistat (Xenical®), sibutramine (Meridia®),
        phenylpropanol-amine (Acutrim®)), or similar over-the-counter medications within 3 months
        of screening.

        Any surgery within 30 days of screening

        Those who currently donate blood, platelets, or plasma

        Any condition that, in the view of the PI or Co-I, places the subject at high risk or poor
        treatment and study compliance.

        We will also enroll 36 participants ages 18-79 years (50% men, 50% women) with low or no
        anxiety as control subjects to participate in only baseline testing (not participate in the
        drug intervention). These subjects will be either lean (body mass index < 25) or on the
        obesity spectrum (body mass index > 30).

        Because obesity is linked with hypertension and type 2 diabetes, enrollment of subjects may
        include those with pre-hypertension or hypertension (systolic blood pressure >/= 120 - <180
        mmHg- average of at least 3 measurements 2 min apart after 10 min seated resting position),
        and/or pre-diabetes (defined as fasting blood glucose between 100-126 mg/dl, fasting blood
        glucose of 140-199 mg/dl at 120 min of an oral glucose tolerance test, or HbA1C of 6-6.5%)
        or type 2 diabetes (defined as fasting blood glucose between >126 mg/dl, fasting blood
        glucose of >199 mg/dl at 120 min of an oral glucose tolerance test, or HbA1C > 6.5%). These
        subjects may be taking anti-hypertensive and/or diabetes (anti-hyperglycemic) medications.
        Subjects will be asked to refrain from medications the morning of the study visit, and to
        bring their medications with them to take immediately following their study visit.

        Inclusion criteria:

        Willing and able to provide written, signed consent after the nature of the study has been
        explained, and prior to any research-related procedures.

        Age is > or = 18 and < or = 79 years

        No history of cardiovascular disease (e.g., heart attack, stroke, heart failure, valvular
        heart disease, cardiomyopathy), or peripheral arterial disease.

        Non-smokers, defined as no history of smoking or no smoking for at least the past 3 months.

        Normal resting 12-lead ECG (no evidence of myocardial infarction, left ventricular
        hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
        fibrillation/flutter, atherosclerosis).

        Blood chemistries indicative of normal renal (creatinine <2.0mg/dl), liver (<3 times upper
        limit for ALT, AST), and thyroid function (TSH between 0.4 - 5.0 mU/L) or on stable thyroid
        medication with no dose change for 3 months.

        Exclusion Criteria:

        Current diagnosis or history of cancer, liver disease, HIV/AIDS

        History of brain tumor, aneurysm or injury

        Clinical diagnosis of mental health disorders such as bipolar disorder or schizophrenia

        History of cardiovascular disease such as heart angioplasty/stent or bypass surgery,
        myocardial infarction, stroke, heart failure with or without LV ejection fraction <40%,
        cardiomyopathy, valvular heart disease, cardiomyopathy, heart transplantation,
        atherosclerosis.

        Current tobacco user or history of tobacco use within the past 3 months (cigarettes,
        cigars, chewing tobacco, Hookah).

        History of lung emphysema, chronic bronchitis or chronic obstructive pulmonary disease
        (COPD).

        Abnormal resting 12-lead ECG (e.g., evidence of myocardial infarction, left ventricular
        hypertrophy, left-bundle branch block, 2nd or 3rd degree AV block, atrial
        fibrillation/flutter, atherosclerosis).

        Serious neurologic disorders including seizures.

        History of renal failure, dialysis or kidney transplant.

        Use of any investigational products or investigational medical devices within 30 days prior
        to screening, or requirement for any investigational agent prior to completion of all
        scheduled study assessments.

        Recent flu-like symptoms within the past 2 weeks.

        Pregnant or breastfeeding at screening, or planning to become pregnant (self or partner) at
        any time during the study. A urinary pregnancy test will be done on all females. If test is
        positive, the subject will be excluded.

        History of rheumatoid arthritis, Grave's disease, systemic lupus erythamatosis, and
        Wegener's granulomatosis.

        Taking anticoagulation, anti-seizure, or antipsychotic agents.

        Start of or dose change to an antidepressant or anti-anxiety medication within the past 3
        months (if no change in medication or dose in past 3 month, then subject will be eligible).

        Immunodeficiency or systemic autoimmune disease.

        History of bleeding disorders or conditions of the microcirculation (i.e. von Willebrand
        disease, Raynaud's disease).

        History of co-morbid condition that would limit life expectancy to <1 year.

        Taking chronic non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin,
        indomethacin, naproxen, acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®) and not able
        or willing to go off of for 2 weeks prior to each study visit.

        Taking cox-2 inhibitors (Celebrex®, Vioxx®, etc) or allopurinol (Zyloprim®, Lopurin®,
        Aloprim®).

        Taking steroids or biologics: corticosteroids (prednisone); methotrexate, infliximib
        (Remicade®), etaneracept (Enbrel®); anakinra (Kineret®).

        Those who are currently donating blood, platelets, or plasma at the time of screening.

        Vulnerable populations (prisoners, etc.) will not be eligible to participate in this study.

        On weight loss drugs (i.e. orilistat (Xenical®), sibutramine (Meridia®),
        phenylpropanol-amine (Acutrim®)), or similar over-the-counter medications within 3 months
        of screening.

        Any surgery within 30 days of screening

        Those who currently donate blood, platelets, or plasma

        Any condition that, in the view of the PI or Co-I, places the subject at high risk or poor
        treatment and study compliance.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 79 Years

Patient description (medical language): A 23-year-old man comes to the emergency department following an episode of syncope.  He was working out when he felt dizzy and passed out without head injury.  He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions.  The patient does not use tobacco, alcohol, or illicit drugs.  His father died suddenly at age 35.  Vital signs are within normal limits.  On physical examination, the patient has a harsh systolic murmur.  The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy.

Patient description (patient's own words): I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average.

Does the patient match the trial criteria? Contradiction