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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

Tracking Information
First Submitted Date  ICMJE September 24, 2015
First Posted Date  ICMJE September 25, 2015
Last Update Posted Date October 17, 2019
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2015)
Muscle sympathetic nerve activity at rest and during mental stress [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02560805 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2015)
  • Change in Baroreflex sensitivity (BRS) at rest and during mental stress [ Time Frame: 12 weeks ]
  • Change in inflammatory biomarkers [ Time Frame: 12 weeks ]
    Inflammatory biomarkers will be assessed using standard assays.
  • Change in Blood Pressure [ Time Frame: 12 weeks ]
  • Change in PTSD symptoms [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV
Official Title  ICMJE Post-Traumatic Stress Disorder and Cardiovascular Disease Risk: Role of Sympathetic Overactivity and Angiotensin II
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Stress Disorders, Post-Traumatic
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • Procedure: Microneurography
    • Behavioral: Combat virtual reality video clip
    • Procedure: Handgrip Exercise
    • Procedure: Cold Pressor Test (CPT)
    • Drug: Sodium Nitroprusside (SNP)
    • Drug: Phenylephrine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 24, 2015)
134
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Melanie Jefferson, MS 404-321-6111 ext 7040 melanie.l.jefferson@emory.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02560805
Other Study ID Numbers  ICMJE IRB00082400
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeanie Park, Emory University
Study Sponsor  ICMJE Emory University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeanie Park, MD Emory University
PRS Account Emory University
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP