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Trial record 78 of 116 for:    Atenolol

Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV (ANG-P)

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ClinicalTrials.gov Identifier: NCT02560805
Recruitment Status : Recruiting
First Posted : September 25, 2015
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Jeanie Park, Emory University

Brief Summary:
The purpose of this study is to find out why patients with post-traumatic stress disorder (PTSD) have an increased risk for heart disease and high blood pressure later in life. A second purpose is to find out what causes PTSD patients to have high adrenaline levels during stress. This study will also test if a medicine called losartan improves high adrenaline levels in patients with PTSD and if a certain gene that has to do with high blood pressure might be associated with high adrenaline levels.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Procedure: Microneurography Behavioral: Combat virtual reality video clip Procedure: Handgrip Exercise Procedure: Cold Pressor Test (CPT) Drug: Sodium Nitroprusside (SNP) Drug: Phenylephrine Drug: Losartan Drug: Atenolol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Post-Traumatic Stress Disorder and Cardiovascular Disease Risk: Role of Sympathetic Overactivity and Angiotensin II
Study Start Date : October 2015
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Veterans
Subjects with post-traumatic stress disorder (PTSD) will be evaluated using microneurography, static handgrip exercise, cold pressor test, combat virtual reality video clip, and baroreflex sensitivity using sodium nitroprusside and phenylephrine. For the second phase, they will be randomized to either losartan or atenolol.
Procedure: Microneurography
Skin will be stimulated with a pencil-shaped electrode to find a certain nerve. Once the nerve is found, two tiny sterile wire needles (about the size of acupuncture needles) will be put in the skin. One needle is put just under the skin at a short distance away from the nerve, and the other one into the nerve. The needles are attached to a computer recorder to record the nerve activity. It may take up to one hour to get the needles in the right place. After the tiny needle is in the right place, investigators record nerve activity at rest for about 10 minutes. Then, it will be recorded throughout the rest of the visit (up to 4 hours).

Behavioral: Combat virtual reality video clip
Subjects will watch a video clip of combat on a computer screen or wearing video goggles.

Procedure: Handgrip Exercise
Subjects will squeeze a hand dynamometer intermittently.

Procedure: Cold Pressor Test (CPT)
Subjects' hand will be submerged in cold water (~0-1°C) up to the wrist for 1 minute.

Drug: Sodium Nitroprusside (SNP)
Subjects will receive sodium nitroprusside 100 µg, which is bolused through an antecubital intravenous catheter.
Other Name: Nitropress

Drug: Phenylephrine
Subjects will receive phenylephrine 150 µg, which is bolused through an antecubital intravenous catheter 60 seconds after the sodium nitroprusside bolus

Drug: Losartan
Subjects will receive Losartan 25 mg once a day orally up to 12 weeks
Other Name: Cozaar

Drug: Atenolol
Subjects will receive Atenolol 25 mg once a day orally up to 12 weeks
Other Name: Tenormin

Experimental: Control
Healthy controls will be evaluated using microneurography, static handgrip exercise, cold pressor test, combat virtual reality video clip, and baroreflex sensitivity using sodium nitroprusside and phenylephrine.
Procedure: Microneurography
Skin will be stimulated with a pencil-shaped electrode to find a certain nerve. Once the nerve is found, two tiny sterile wire needles (about the size of acupuncture needles) will be put in the skin. One needle is put just under the skin at a short distance away from the nerve, and the other one into the nerve. The needles are attached to a computer recorder to record the nerve activity. It may take up to one hour to get the needles in the right place. After the tiny needle is in the right place, investigators record nerve activity at rest for about 10 minutes. Then, it will be recorded throughout the rest of the visit (up to 4 hours).

Behavioral: Combat virtual reality video clip
Subjects will watch a video clip of combat on a computer screen or wearing video goggles.

Procedure: Handgrip Exercise
Subjects will squeeze a hand dynamometer intermittently.

Procedure: Cold Pressor Test (CPT)
Subjects' hand will be submerged in cold water (~0-1°C) up to the wrist for 1 minute.

Drug: Sodium Nitroprusside (SNP)
Subjects will receive sodium nitroprusside 100 µg, which is bolused through an antecubital intravenous catheter.
Other Name: Nitropress

Drug: Phenylephrine
Subjects will receive phenylephrine 150 µg, which is bolused through an antecubital intravenous catheter 60 seconds after the sodium nitroprusside bolus




Primary Outcome Measures :
  1. Muscle sympathetic nerve activity at rest and during mental stress [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in Baroreflex sensitivity (BRS) at rest and during mental stress [ Time Frame: 12 weeks ]
  2. Change in inflammatory biomarkers [ Time Frame: 12 weeks ]
    Inflammatory biomarkers will be assessed using standard assays.

  3. Change in Blood Pressure [ Time Frame: 12 weeks ]
  4. Change in PTSD symptoms [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • veterans ages 18-65 years old with PTSD and without PTSD (controls) matched for age, gender, and race.

Exclusion Criteria:

  • pregnancy
  • hypertension
  • diabetes
  • heart or vascular disease
  • illicit drug use
  • excessive alcohol use (>2 drinks per day)
  • hyperlipidemia
  • autonomic dysfunction
  • current treatment with clonidine, beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, or angiotensin II receptor blockers (ARBs)
  • treatment with monoamine oxidase (MAO) inhibitors within the last 14 days
  • any serious systemic disease
  • chronic kidney disease defined as estimated glomerular filtration rate (GFR) < 60 cc/min
  • hyperkalemia (serum potassium > 5 meq/dL)
  • systolic blood pressure < 100 mm Hg
  • diastolic blood pressure < 60 mm Hg
  • heart rate < 50 beats/min
  • known hypersensitivity to ARBs or beta blockers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560805


Contacts
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Contact: Melanie Jefferson, MS 404-321-6111 ext 7040 melanie.l.jefferson@emory.edu

Locations
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United States, Georgia
Atlanta VA Medical Center Recruiting
Decatur, Georgia, United States, 30033
Contact: Melanie Kankam, MS    404-321-6111 ext 7040    melanie.l.jefferson@emory.edu   
Principal Investigator: Jeanie Park, MD         
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Jeanie Park, MD Emory University

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Responsible Party: Jeanie Park, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02560805     History of Changes
Other Study ID Numbers: IRB00082400
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Atenolol
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Losartan
Nitroprusside
Phenylephrine
Oxymetazoline
Angiotensin II
Giapreza
Angiotensinogen
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents