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 : September 2, 2020
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |

Arm | Intervention/treatment |
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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.
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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 |
- Muscle sympathetic nerve activity at rest and during mental stress [ Time Frame: 12 weeks ]
- 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 ]

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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 |
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

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
Contact: Melanie Jefferson, MS | 404-321-6111 ext 7040 | melanie.l.jefferson@emory.edu |
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 |
Principal Investigator: | Jeanie Park, MD | Emory University |
Responsible Party: | Jeanie Park, Associate Professor, Emory University |
ClinicalTrials.gov Identifier: | NCT02560805 |
Other Study ID Numbers: |
IRB00082400 |
First Posted: | September 25, 2015 Key Record Dates |
Last Update Posted: | September 2, 2020 |
Last Verified: | September 2020 |
Atenolol Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders Losartan Nitroprusside Phenylephrine Oxymetazoline 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 Neurotransmitter Agents Protective Agents Sympatholytics |